Fundraising Proposal Form
Event: Lions Lunch Date: 19th May 2017 Summary: Ahead of Ride With The Pride, the 4 bike ride leaders Shane Williams, Mike Hall, Andy Powell – all are British Lions - and Xavier Rush who is a former All Black - will hold a special Lions Lunch at the Principality Stadium in Cardiff looking ahead at the British & Irish Lions Tour of New Zealand and the bike ride. Comedian Rod Woodward has been asked to perform – awaiting confirmation he is available. The lunch will be held on Friday 19th May from 1pm. The lunch will aim to attract city companies mainly. We will be seeking a main sponsor for the event. The venue holds 250 guests. We will aim to sell a minimum of 200 tickets.
Key Objectives: • To host a successful event • To attract new supporters • To attract quality speakers • To attract new companies • To attract beneficial publicity • To increase awareness of Velindre
Event will raise money for which fund? General (Ride With The Pride Event)
Celebrity involvement? Yes
Target audience/Market: City companies, Directors, influential rugby supporters, current supporters
Is event repeatable? Yes ahead of future Lions tours
Risk Probability Likely Impact on Contingency Income/Expenditure Not selling enough Low Event will not go ahead Seeking main sponsor for the tables/not sourcing a with less than 12 event. sponsor tables. If no sponsor is sought event will still be profitable as ticket price will cover costs and make a profit. Monitor sales ahead of the event. Market as widely as possible, using current supporters, press and social media - utilising patrons with large social media followers. Panellists will market event and help sell tables. Ask Uprise Marketing to help market the event as they held a similar event for Velindre with Sam Warburton in May 2016 for Velindre so will have mailing list of attendees. 1
Celebrity panellists/MC Medium None Have other celebrities on standby. pulling out Recruit more than needed with this in mind. Marketing materials will state panel subject to change. Have good contacts with rugby celebs/MC’s so replacements will be possible. Not sourcing enough Low Low Have good supply of prizes prizes already. Have contacts for other prizes.
2
Velindre NHS Trust Charitable Funds
Event Name: Lions Legends Lunch Event Date: 19 May 2017 Unique Event Registration Number: CFC Approval date: CFC Agenda Item Number:
Income / Gross Revenue Estimated Actual % Tickets: 200 x £750 15,000.00 Raffle: 200 x £10 2,000.00 Auction 3,000.00 - Sponsor 5,000.00 Total Income / Gross Revenue £ 25,000.00 100% £ - 100% Direct Costs Excluding Publicity Estimated Actual Meals: 220 x £32 £7,040 - Framing of auction items 1,000.00 Screen & projector, PA System and lighting 1,200.00 - Total Direct Cost Excluding Publicity £ 9,240.00 37% £ - #DIV/0! Publicity Estimated Actual Design of flyer & programme 300.00 - Print of programme 300.00 - Total Publicity Cost £ 600.00 2% £ - #DIV/0! Staff Cost Estimated Actual Head of Fundraising 5 hours 130.90 - Deputy Head of Fundraising 259.65 - Total Staff Cost £ 390.55 2% £ - #DIV/0! Total Event Expenses Estimated Actual £ 10,230.55 41% £ - #DIV/0!
Total Event Profit and Loss / Net Revenue Estimated Actual £ 14,769.45 59% £ - #DIV/0!
The estimated cost to the charitable funds £ 10,230.55 to raise £ 25,000.00
The estimated cost to the charitable funds is £ 0.41 to raise every £1
The final actual cost to the charitable funds £ - to raise £ -
The final cost to the charitable funds is #DIV/0! to raise every £1 3
If Estimated expenditure authorised previously by CFC has been modified, explain the reason:
Name of Issuing Officer:
Signature: Date:
Name of Authorising Officer:
Signature: Date:
Date to be Presented to CFC for finalisation: Agenda Item No.:
4
Fundraising Authorisation Form
VELINDRE NHS TRUST
CHARITABLE FUNDS AUTHORISATION FORM FOR FUNDRAISING EVENTS
Event: Lions Lunch
Date: 19th May 2017
Fund No:
Fund Name:
Amount Authorised by Charitable Board: £
Date:
Payee:
Address:
------
Name of Issuing Officer:
Signature: Date:
Name of Authorising Officer:
Signature Date:
Name of trust Board Member:
Signature: Date:
5
CHARITABLE FUNDS COMMITTEE REPORT
RUNNING VESTS 2016 \ 17
Meeting Date: 8th November 2016
Author: Andrew Morris Head of Fundraising, VCC
Sponsoring Executive Director: Andrea Hague, Director Velindre Cancer Centre
Report Presented by: Andrew Morris Head of Fundraising, VCC
Committee/Group who have received or Charitable Funds Operational Management th considered this paper: Group – 20 October 2016.
Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The Charitable Funds Committee are asked to APPROVE the contents of this report.
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick)
Equitable and timely services
Providing evidence based care and research which is clinically effective Supporting our staff to excel
Safe and reliable services
First class patient /donor experience
Spending every pound well
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards • Governance, Leadership and Accountability • Staff and resources • Individual Care • Effective Care • Dignified Care
2 Running Vests 2016-17
1. Introduction / Background
Velindre has a great number of supporters who raise funds by entering running events, 5 and 10ks and half and full marathons. It is important that runners wear Velindre branded materials when training and running as this helps with beneficial publicity. They are ideal for media promotions, through press and social media.
2. Timing/Description:
Running activities take place all year.
3. Financial Impact:
From runners taking part in the Cardiff Half Marathon alone in the last 3 years, £157,971 has been raised from just 280 runners. To ensure our runners have branded vests for the next 2 years we would like to purchase around 800 vests at an approximate costs of £6,000.
4. Quality, Equality, Safety and Patient Experience Impact:
The vision of the charity supports the Trust’s provision of world class research-led treatment care and support for patients, families and carers affected by cancer and those who are involved in the donation of blood products. Any fundraising activity is considered in this context and that of the charity objectives outlined below. • General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas. • Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services. • Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.” • Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services.
By the very nature of how charitable funds are used it supports improving quality and patient/donor experience.
5. Considerations for Board / Committee:
Good quality running vests are essential so that runners will continue to wear the vests, prior to their event during training, while taking part in their activity, and following gathering publicity for Velindre.
See Appendix 1 for design.
6. Next Steps:
The Charitable Funds Committee are asked to APPROVE the new Velindre Fundraising running vests
.
Page 2
CHARITABLE FUNDS COMMITTEE
BUSINESS CASE FOR Gynaecological Radiotherapy Development Programme
Meeting Date: 8th November 2016
Author: Louise Hanna – Consultant VCC
Sponsoring Executive Director: Andrea Hague – Director VCC Report Presented by: Dr Louise Hanna/ Andrea Hague – Director VCC Committee/Group who have received or (Delete as appropriate) considered this paper: • Divisional Senior Management Team – Date: April/ May 2016 • Charitable Funds Operational Management Group – Date: 20/10/2016
Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The Charitable Funds Committee is asked to APPROVE funding for the Gynae Development Programme as outlined in the enclosed business case.
This report supports the following Velindre NHS Trust Charity Objectives (please tick)
General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas. Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services. Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.” Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services, which will further the following aims; • The investigation of the causes of cancer and the prevention, cure, treatment and defeat of cancer in all its forms; • The advancement of scientific and medical education and research in topics related to cancer; and • The furtherance of any other charitable purpose for the relief of persons diagnosed with cancer. Welsh Blood Service - For any charitable purpose or purposes relating to the National Health Service wholly or mainly for the services of the Blood Transfusion Service in the area served by the Welsh Blood Service.
2 Business Case
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick)
Equitable and timely services
Providing evidence based care and research which is clinically effective Supporting our staff to excel
Safe and reliable services
First class patient /donor experience
Spending every pound well
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards
• Individual care • Timely care • Effective care • Dignified care • Person centred care
Page 2
3 Business Case
1. Introduction / Background
1.1 Radical radiotherapy is the cornerstone of many gynaecological cancer treatments; it is used with the aim of curing patients or reducing the chances of cancer returning after surgery. It is typically the main treatment for every patient with locally advanced cervical, vulval or vaginal cancer, and it is used in patients with endometrial (womb) cancer if their cancer has features indicating a risk of recurrence after surgery. Every patient has an individualised radiotherapy treatment plan that is designed to give the best outcome for cancer control, while minimising adverse side effects. 1.2 Radiotherapy treatments have a risk of side effects. These can be acute (occurring during treatment or within three months) or late (occurring more than three months after treatment). The side effects and how to deal with them are increasingly well understood. It is important that patients who experience side effects following radiotherapy are identified and treated. This may involve referral to other specialty groups. For example, gastrointestinal side effects are common after pelvic radiotherapy, and patients with troublesome gastrointestinal side effects need to be referred to gastroenterology teams for investigation and treatment. Patients with troublesome urinary symptoms may require referral to urology teams. 1.3 Gynaecological radiotherapy in Velindre Cancer Centre has undergone significant change in recent years. External beam radiotherapy is now planned using 3D conformal and VMAT techniques, compared with ‘unplanned’ treatments that were used a few years ago. Image guided brachytherapy has been developed using CT and MRI planning. These new treatments are very complex to plan, implement and deliver. Effective team working is essential for planning and delivery of complex radiotherapy treatments. Safe delivery of radiotherapy is highly dependent on communication at many different levels and between different staff groups: poor communication and lack of team working is a key contributory factor for errors in radiotherapy.1 Good multidisciplinary working with clear communication is essential, and specific multidisciplinary teams should hold regular multidisciplinary meetings to review
1 The Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, National Patient Safety Agency, British Institute of Radiology. Towards Safer Radiotherapy. London: The Royal College of Radiologists, 2008.
Page 3
4 Business Case
individual complex cases and develop radiotherapy techniques.2 1.4 Radiotherapy developments have enhanced the service provided to gynaecological cancer patients. The gynaecological clinical oncologists have also identified gaps in the current service that are barriers to further service development: a) There is no team radiotherapy planning session. This means that radiotherapy plans are formulated without the benefit of peer review and team discussion. b) There are no structured protocols for following up patients after pelvic radiotherapy. There is no database of patients who have undergone pelvic radiotherapy treatments and no written protocols on how to identify patients with side effects following treatment. There is no system for prospectively recording information on late effects of cancer treatment. Referral of patients to specialist teams is largely ad hoc.
2. Timing:
2.1 Establish weekly radiotherapy peer review sessions. Evaluate the impact of the sessions e.g. number of cases discussed, number of treatment plans adjusted. 2 years
2.2 Establish a weekly late effects clinic. Establish a database of patients treated with pelvic radiotherapy for cervical cancer. Establish written protocols for follow up, systematic ways of identifying side effects of radiotherapy and establish referral pathways for investigation and treatment. 2 years
3. Description: 3.1. To hold a weekly team gynaecological radiotherapy planning meeting. The meeting will comprise oncology consultants, physicist and radiographers. Gynaecological radiotherapy is complex and it requires individual radiotherapy plans. A weekly meeting to discuss indications for treatment, target volumes and dose enable a consistent approach among the gynae team. The benefit of a weekly radiotherapy planning meeting will be to increase peer support to aid decision making in complex cases, and to ensure participation in any available radiotherapy trials. The meeting will also provide a
2 The Royal College of Radiologists, Society and College of Radiographers, Institute of Physics and Engineering in Medicine, National Patient Safety Agency, British Institute of Radiology. Towards Safer Radiotherapy. London: The Royal College of Radiologists, 2008.
Page 4
5 Business Case
platform to plan further developments in gynaecological radiotherapy planning and delivery.
3.2. To commence a weekly late effects clinic. Pelvic radiotherapy is known to produce long term side effects. A dedicated late effects clinic will enable patients to be seen by a variety of different healthcare professionals including oncology, gastroenterology and urology. The benefit of a late effects clinic will be to increase support and holistic care for patients who have received pelvic radiotherapy. Further benefits will include establishing a database of patients receiving pelvic radiotherapy as the main part of their treatment, and to produce structured protocols for follow up. The gastrointestinal nurse specialist will identify patients and facilitate investigation, treatment and counselling of patients.
4. Financial Impact:
4.1. The financial impact is predominantly in staff costs to enable the service developments described above.
5. Quality, Equality, Safety and Patient Experience Impact:
5.1. The activity considered by the Committee supports the objectives of the Charity as outlined below:
• General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas.
• Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services.
• Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services.
6. Considerations for Board / Committee:
6.1. Please refer to the full business case enclosed with this report. Option appraisals, impact assessments, financial assessment and consideration of risks have been explored within the business case to assist the Committee in their decision as to whether to approve this funding request. Prior to submission to the Committee, the business case has been considered by the Fund Holder and is supported. The Corporate Finance Department have confirmed that funding is available in respect of the fund identified.
Page 5
6 Business Case
7. Next Steps:
7.1. The Charitable Funds Committee are asked to APPROVE funding for the Gynae Development Programme as outlined in the enclosed business case
Page 6
7 Business Case
Appendix 1
VELINDRE NHS TRUST CHARITABLE FUNDS
BUSINESS CASE REPORT TO BE SUBMITTED TO THE CHARITABLE FUNDS COMMITTEE
THIS DOCUMENT HAS TO BE COMPLETED FOR PROJECTS / GRANTS / BIDS WITH EXPENDITUREOVER £5,000
1. BUSINESS CASE TITLE:
Gynaecological Radiotherapy Development Plan
2. BUSINESS CASE PREPARED BY:
Louise Hanna
3. BUSINESS CASE SPONSORTED BY:
Andrea Hague
4. UNIQUE BUSINESS CASE NUMBER: 5. PROPOSAL TOTAL EXPENDITURE: (Requested from Corporate Management Accountant / HQ)
2020/22 £141,728 over 2 years
6. FUND NAME: 7. FUND NUMBER: (Requested from Corporate Management Accountant / HQ) (Requested from Corporate Management Accountant / HQ)
Research Gynaecological 6307
8. FUND BALANCE & CURRENT COMMITTMENTS: (Requested from Corporate Management Accountant / HQ)
Fund Actual Balance Opening Forecasted Forecasted Forecasted as at Balance Income Current Balance 31/08/2016 01/04/2016 2016/17 Committments 31/03/2017 2016/17 6307 - Gynae 230,511 218,396 37,512 -14,479 241,429
9. BRIEF DESCRIPTION OF PROPOSAL:
The proposal is to enhance gynaecological radiotherapy services in Velindre Cancer Centre through multidisciplinary team working and development.
A dedicated gynaecological radiotherapy planning meeting will enable effective team communication and discussion of complex cases, as well as optimising participation in clinical trials and providing a
Page 7
8 Business Case
platform for adoption of new radiotherapy techniques.
A radiotherapy late effects clinic will improve the service currently provided for patients after radiotherapy by providing access to a multidisciplinary group of healthcare professionals and the opportunity to develop pathways for investigation and treatment.
10. REASONS FOR PROPOSAL: Provide in this section the reason for making the proposed changes. In particular, it should be indicated if they have an urgent clinical risk or if they are considered to be a “spend Save” initiative. You should ensure that these reasons: • Are consistent with the Charitable Funds objectives, aims, and values as well as supporting the values of the Trust. • Assist the Charitable Funds in moving towards its strategic vision. • Are identified as a priority within the Charitable Funds strategic and financial framework. • Assist the Charitable Funds in implementing external policies, plans, and reports.
The reasons for the proposal are outlined in the introductory section.
The proposal is consistent with the Trust’s values:
Be accountable: The gynaecological team will be more empowered to fulfil its role and deliver a high quality service for patients.
Be bold: The proposal is innovative. We are not aware of any other dedicated pelvic radiotherapy late effects clinic with a range of multi-disciplinary professionals.
Be caring: The gynaecological team aim to provide excellence in clinical interventions, including the delivery of radiotherapy and the management of complications of radiotherapy.
Be dynamic: The proposal is an excellent opportunity to improve the services for gynaecological patients.
11. BENEFIT / IMPACT OF PROPOSAL: Indicate the anticipated benefits and impact of the proposed project:
As described in the introductory section, the benefit and impact of the proposal is to enhance the gynaecological radiotherapy service in Velindre Cancer Centre, for delivery of radiotherapy and for identifying and treating side effects of radiotherapy.
The radiotherapy team meeting will increase peer support and discussion to aid decision making in complex cases and to ensure participation in available radiotherapy trials. It will provide a platform to plan further developments in gynaecological radiotherapy planning and delivery.
The late effects clinic will enable patients to be seen by a multidisciplinary team of healthcare professionals including oncology, gastroenterology and urology. The benefit of a late effects clinic will increase support and holistic care for patients who have received pelvic radiotherapy. Further benefits will include establishing a database of patients who have received pelvic radiotherapy, to produce structured protocols for follow up.
12. LIST OF OPTIONS CONSIDERED AND PREFERRED OPTION:
Option Pros Cons Do nothing Cost neutral Failure to utilise charitable funds – risk that charitable fund obligations will not be met and that
Page 8
9 Business Case
fundraisers will direct their efforts elsewhere. Lack of development of advanced gynaecological radiotherapy in Velindre which would fall behind other centres in UK Radiotherapy planning Radiotherapy service Radiotherapy meeting only developments enabled. treatments enhanced Better outcomes for without improvements patient. Reputational in patient care following enhancement for treatment Velindre Cancer Centre. Radiotherapy late Improved services for Radiotherapy will fail to effects clinic only patients following pelvic keep up with advances radiotherapy for in the rest of the UK gynaecological cancer Radiotherapy planning Enhanced radiotherapy Costs. meeting and late effects treatment and care of clinic patients after radiotherapy. Holistic care.
13. RISK ASSESSMENT: Indicate how the project will manage both strategic and operational risks identified as part of the risk assessment. In particular, you should make reference to risks which initiate the need for change, those which need to be managed in implementing the project and the risks identified with not proceeding with the project:
Strategic risks: The risk of not proceeding with the project is that gynaecological radiotherapy in Velindre Cancer Centre will not develop and will fall behind other centres in the UK.
Operational risks: There is a risk that adequate space may not be available because it is well recognised that the Cancer Centre is short of meeting room space and clinic space.
14. COMPLIANCE Provide evidence that the proposed project meets the relevant requirements/standards including Health and Safety regulation, Legislation (e.g. Human Rights, Data Protection), Clinical Governance requirements, National Service Frameworks, NICE Regulations, Welsh Risk Management Standards, Commission for health improvement requirements and the Strategic and Financial Framework.
The project will be managed by members of the gynaecological site specific team which undergoes regular review and appraisal and which falls under the Trust’s clinical governance structures. Honorary Velindre contracts will be sought for any staff from other hospitals who attend the late effects clinic.
15. RESEARCH & DEVELOPMENT APPROVAL: If this project includes R&D activity, please provide evidence that this project has been approved by the R&D Committee e.g. date approved. R+D approval not required for this project. If any research is planned during the project, appropriate R+D approval will be sought.
16. FUNDING REQUIREMENTS:
Page 9
10 Business Case
Provide here an indication of the anticipated costs for the whole project. This should include breakdown of Capital or Revenue costs. Within the revenue cost you should indicate Staff costs, Non-staff cost and Equipments
Description Staff Non Staff Capital Total Expenditure Expenditure Expenditure Expenditure RT meet consultant sessions x 2 £ 48,720.00 £ - £ - £ 48,720.00 RT meet radiographer session x 0.5 £ 4,428.00 £ - £ - £ 4,428.00 RT meet physics or planner session x 0.5 £ 4,428.00 £ - £ - £ 4,428.00 Late effects consultant sessions x 2 £ 48,720.00 £ - £ - £ 48,720.00 Late effects gynae CNS sessions x 1 £ 8,858.00 £ - £ - £ 8,858.00 Late effects CNS or Physio Urology x 1 £ 8,858.00 £ - £ - £ 8,858.00 Late effects Gastro CNS x 2 £ 17,716.00 £ - £ - £ 17,716.00 £ 141,728.00 £ - £ - £ 141,728.00 Total
17. PROPOSED FUNDING CASH FLOW: Indicate here the length of the project and the expenditure expected during the financial period. Example - Year 1 Expenditure Total 2014/15 (April 2014-March 2015). Please note that funding cannot be requested for more than a three years period. The Total Funding Cash Flow should match the Total Funding Requirements indicated on the table above
Description Expenditure Expenditure Expenditure Total year 1 year 2 year 3 Expenditure 2017/18 2018/19 RT meeting £ 28,788.00 £ 28,788.00 X £ 57,576.00 Late effects clinic £ 42,076.00 £ 42,076.00 X £ 84,152.00 £ - Total £ 70,864.00 £ 70,864.00 £ - £ 141,728.00
The radiotherapy planning meeting and the late effects clinic will run for two years initially.
18. FUNDING PROPOSAL Indicate here which fund or funds you are expecting to pay for this project / please, note that in order to request money from different restricted funds the project has to be strongly linked between the funds activities.
This is an application to the Aphrodite Appeal Fund which is a fund dedicated to gynaecological cancer.
19. TIMESCALE / PROJECT MILESTONES Indicate here the length of this project – This must include a start date and end date. (Please indicate if there is likely to be any lead time which may delay the start date).
** If a project has not commenced within six months of the approved start date then you will be requested to provide a progress update to the Charitable Funds Committee who will consider whether funding will continue
Page 10 11 Business Case
depending on the explanation provided**
The project will commence as soon as job planning arrangements allow.
20. PROJECT MANAGEMENT ARRANGEMENTS State the proposed arrangements for managing this project and list those who will be involved in the process.
Dr Louise Hanna and Dr Emma Hudson will manage this project.
21. IMPACT ASSESSMENT AND ACTIONS REQUIRED WHEN THE PROJECT IS COMPLETE: What will happen at the end of this project? State whether there is likely to be any further demands on the charity, or Velindre NHS Trust revenue accounts as a result of this proposal coming to an end and any action required to mitigate risks.
At the end of the project, the project will be evaluated using criteria such as below. If successful, the team will look towards extending the project. This may involve further applications to the charity or Velindre NHS Trust revenue accounts. Evaluation of the project will ensure that any further applications, if made, are supported by robust data of the effectiveness of the project.
22. PROJECT SUCCESS MEASUREMENT Detail here what criteria will be used to measure the success of the project. The results will be gauged when completing the annual evaluation report
The following are examples of measurable outputs: • Radiotherapy planning meetings • Number of patients discussed in multidisciplinary radiotherapy planning meeting • Frequency of meetings • Development of new radiotherapy planning protocols • Participation in clinical trials • Late effects clinic • Number of patients seen in clinic • Number of referrals to gastroenterology and urology • Patient satisfaction survey • Development of pathways for investigation and treatment
23. FUND HOLDER APPROVAL Please confirm that the fund holder has supported this funding request prior to it being submitted to the CFC.
Confirmation received Yes ( ) No ( )
24. DATE SUBMITTED TO THE CHARITABLE FUNDS COMMITTEE
27 10 16
SECTIONS 25-26 TO BE COMPLETED BY CORPORATE FINANCE FOLLOWING CFC MEETING.
Page 11 12 Business Case
25. CHARITABLE FUNS COMMITTEE APPROVAL
Yes ( ) No ( )
If yes, date approved:
26. GRANT APPROVAL LETTER SENT
Yes ( ) N/A ( )
If yes, date sent:
Page 12
Charitable Funds Committee
LITEFORM study: Low Level Laser Therapy for Oral Mucositis in Head & Neck Cancer.
Application to Charitable Funds
Meeting Date: 8th November 2016
Author: Dr Mererid Evans
Sponsoring Executive Director: Professor Peter Barrett Lee/Ms Andrea Hague
Report Presented by: Dr Mererid Evans
Committee/Group who have received or This paper was considered (and fully supported) by the considered this paper: R&D Committee 21/09/2016.
The LITEFORM study described in this application has also been considered by RT Trials meeting & was supported (pending further information on room suitability & staff resources contained in this document).
The Charitable funds Operational Management Group: 20/10/2016
Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The CFC is asked to approve the attached business case Life form Study.
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick)
Equitable and timely services
Providing evidence based care and research which is clinically effective Supporting our staff to excel Safe and reliable services First class patient /donor experience Spending every pound well
[Report 2Title]
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards
• The new development and research described in this application are absolutely focused on delivering person centred care. The following standards are upheld:
• Safe care: I am kept safe and protected from avoidable harm through appropriate care treatment and support • Effective care: Interventions to improve my health are based on good quality and timely research and best practice • Staff and resources: Quality trained staff will be fully engaged in delivering excellent care and support to me and my family
The purpose of the application is to reduce toxicity for patients with Head and Neck cancer undergoing radiotherapy/chemoradiotherapy at Velindre Hospital.
The aim is to set up a new intervention (Low Level Laser Therapy), delivered through the context of a clinical trial (LITEFORM). This will be done through collaboration between the clinical, radiotherapy and radiation protection teams at Velindre, together with support from the R&D Department.
The application has received full support from the R&D Committee. This application requests funding from the Head and Neck Charitable Fund to purchase equipment and radiographer time to run the study at Velindre.
Page 2
3 [Report Title]
1. Introduction and Background
1.1. Background
Oral mucositis is one of the most frequent and distressing complications observed in patients receiving cancer treatment and is seen in nearly all patients who receive radiotherapy for the treatment of head and neck cancer. Oral mucositis manifests as painful ulceration of the mucous membranes lining the oral cavity (mouth, including the tongue and inside of the cheeks) and pharynx (throat) which frequently impairs the patients ability to eat and drink. Radiotherapy associated mucositis peaks at weeks 4 to 6 of treatment and usually lasts for weeks after the completion of treatment. The effects of oral mucositis are currently managed in the radiotherapy review clinic by prescribing mouthwashes and analgesics (including morphine-based pain killers) but, despite these interventions, patients are often still unable to eat and drink sufficient amounts to maintain their weight and hydration throughout radiotherapy and frequently require admission to the ward for enteral (tube) feeding and/or symptomatic support. Oral mucositis has been shown to be associated with impaired nutritional status and quality of life, increased duration and cost of hospital stay, and interruptions or dose reductions in chemotherapy or radiotherapy. Because of these implications, research has been focused on different preventive and treatment strategies for oral mucositis.
The Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO) have published guidelines for the prevention of oral mucositis. One recommended intervention was low level laser therapy (LLLT), also referred to as photobiomodulation, in patients receiving head and neck radiotherapy. A more recent systematic review and meta-analysis of eighteen RCTs (1144 patients) published in 2014 concluded that prophylactic LLLT reduced the overall risk of severe mucositis (risk ratio (RR) 0.37, 95% confidence interval (CI) 0.20 to 0.67; P = 0.001). LLLT also reduced the following outcomes when compared to placebo/no therapy: severe mucositis at the time of anticipated maximal mucositis (RR 0.34, 95% CI 0.20 to 0.59), overall mean grade of mucositis (standardized mean difference 21.49, 95% CI 22.02 to 20.95), duration of severe mucositis (weighted mean difference 25.32, 95% CI 29.45 to 21.19) and incidence of severe pain (RR 0.26, 95% CI 0.18 to 0.37). It concluded that prophylactic LLLT reduced severe mucositis and pain in patients with cancer and Haemopoietic Stem Cell Transplantation (HSCT) recipients. Future research should identify the optimal characteristics of LLLT and determine feasibility in the clinical setting.
The UK LITEFFORM study will assess the benefit of LLLT in Head and Neck cancer patients receiving radiotherapy, for the first time in the context of in a phase III clinical trial. Velindre has been invited to be one of 7 UK centres involved in the internal pilot phase of the study. The trial is led by the Newcastle Clinical Trials Unity (Chief Investigator: Mr Mike Nugent) and is funded by the HTA, initially as a pilot study, with full funding being released by the HTA if the pilot is successful. 7-10 sites will be involved after the pilot phase and recruitment will be carried out over a total of 2 years.
2. Timing:
Newcastle Clinical Trials Unit (NCTU) will aim for accelerated (fast-track) start-up phase, going straight to recruitment across 7 sites where there is established capacity and feasibility (Velindre has been chosen as one of these sites). Fast track or accelerated start -up is a reported goal of commercial processes to support industry studies but has not been used in head and neck trials previously. Fast track start-up offers economies of scale in terms of NCTU paperwork; setting multiple sites in phase with each other across the CRN; avoidance of repeated amendments to approvals and over-iterative contracting processes. The LiTEFORM start up will culminate in a ‘LiTEFORM Launch Month’ during month 4.
The launch month will constitute a turning point in the trial from its preparatory phase to the opening of recruitment in the internal pilot. It will incorporate a programme of site visits such that a co-applicant with a member of the NCTU trial management team will visit each site within in a three week period. All site PIs and key staff are also expected to attend the LiTEFORM Launch meeting. Thereafter recruitment will commence across all 7 sites. The application of this set up will be subject to rigorous Mixed Methods qualitative evaluation.
The pilot study will be considered a success if 7 out of the 10 sites are set up and recruiting 2 patients per month in the final five pilot months. There is a target of recruiting a total of 100 patients within the 9 month pilot phase. The process will be overseen by the Data Monitoring Committee and the Trial Steering Committee prior to consideration by the HTA who will decide whether to release the full funding. Subsequent to this, the aim is to recruit the remaining 280 patients during the 15 months following the pilot for a total UK recruitment target of 380 patients over 2 years.
We are awaiting confirmation of when the start-up phase of the study will start. In the meantime, we are requesting support to purchase the equipment needed to run the study at Velindre and, with the support and advice of radiation protection officer Matthew Ager, set up LLLT as a new development at Velindre.
3. Description:
Page 3
4 [Report Title]
3.1 Study Summary
Participant identification Patients will be identified by investigators as suitable following head and neck MDT decision making. They will be invited to join the study at the time of consent for radiotherapy.
Randomisation Once consent is completed, patients will be randomised using a web based system. The patients will be randomised to either sham or active LLLT. Patients will be allocated a unique trial number. This unique number will be crucial throughout the trial as it will link to either an A or B code on the LLLT devices.
Intervention Patients will be treated using red light at 660nm, 3J per spot, 1cm2 spot size, power output of 50mW. The exposure time is 60 seconds per spot, treating 6 anatomical sites within the oral cavity, but avoiding the primary site. This will be delivered in a locked room with windows and mirrors covered or absent, and with a laser warning on the door in accordance with the local rules established by laser protection supervisor. LLLT will be delivered by a Laser-trained nurse, radiographer or AHP. It is envisaged that trained radiographers will deliver the treatment at Velindre. The operator of the laser will select the allocated code on the laser device when the patients attend for LLLT. Patients will be scheduled for LLLT sessions which last around 30 minutes. These will be on their appointment card as part of their treatment booking and will take place at a convenient time within the radiotherapy department. A suitable room will be designated for this purpose and is currently being identified by Jane Mathlin, radiographer, together with Matthew Ager, Velindre Radiation Protection Advisor.
Blinding/Allocation concealment In accordance with standard laser safety procedures, the laser unit is only switched on once the operator is wearing the protective glasses and the patient has eye shields on. The glasses will block red light and prevent those delivering LLLT knowing whether the machine is on sham or treatment mode. The machine will bleep audibly at the completion of dose delivery for each of the targeted sites. When treatment is complete, the machine must be switched off prior to removal of safety eyewear. There is a risk of unmasking for the operator if they remove or do not wear the safety glasses. This, however, would be a breach of laser safety rules. If this does happen, the operator will be asked to remain discrete and not convey this knowledge to the participants. The individual delivering treatment will not be involved in assessing the outcome.
Outcome Measures: Day 1 of radiotherapy will be taken as the LiTEFORM baseline.
The primary outcome is OMWQ-HN measured by self-report at 6 weeks following start of radiotherapy treatment. This point is selected as being the point by which mucositis is likely to be its most severe.
Secondary outcomes are: • WHO mucositis scores (weekly clinical assessment) • Days of feeding tube use (weekly clinical assessment then collected through the health utilization questionnaire) • Body mass index at baseline, weekly for 6 weeks and post radiotherapy months 4 and 14 • Analgesia usage (weekly clinical assessment then collected through the health utilization questionnaire) • Unscheduled admission (weekly clinical assessment then collected through the health utilization questionnaire) • Treatment interruptions (weekly clinical assessment then collected through the health utilization questionnaire) • Quality of life (EORTC QLQ C30 / HNC 35 / EQ-5D 5L) at baseline, week 6 and 14 months • OMWQ-HN at weeks 1-5 inclusive • MDADI at baseline, months 4 and 14, • PSS Normalcy of Diet weekly at weeks 1-6, then at months 4 and 14, • Timed water swallow at baseline, week 6, months 4 and14. • Safety (survival, recurrent/persistent disease at 14 months). • Economic outcomes – • Cost to NHS and patients at 14 months, quality adjusted life years (QALY) based on responses to EQ-5D 5L, incremental cost per QALY gained over 14 months. Health utilisation questionnaire administered at 6 and 14 months. Participant time and travel questionnaire at end of follow up
3.2 Health technologies being assessed
LLLT: Low-level laser therapy (LLLT) is a local application of a monochromatic, narrow-band, coherent light source using a laser generated by laser machine to treat a variety of conditions including oral mucositis. Low level lasers are class 3b lasers meaning that they do not cut or burn, but may injure the eye. LLLT arm:
Page 4
5 [Report Title]
An appropriately trained and accredited operator (radiographer at Velindre) will treat the head and neck cancer patients who will be receiving radiotherapy/chemoradiotherapy by employing a laser machine in a designated treatment room certified by local Laser Safety Officer with appropriate warning signs outside the laser room. Operators will receive both manufacturer’s instruction and training from the trial team during the trial start up period in an effort to standardize care. The laser device itself will be standardised across all centres (see Financial section 4). Dosing: Patients will receive LLLT dosage= 3.0 Joules/point, total dosage/session = 36–40 J, spot size= 1 cm2, 20-30min/session, 3 sessions per week by non-contact method at six pre-determined anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth, and palate excluding the primary cancer site) shortly before or after (chemo)radiotherapy sessions for 6 weeks. Eye protection: As a class 3b laser there is a risk of eye damage. The patient will wear adhesive eye shields throughout treatment. These create a total blackout. The operator will wear appropriate wavelength specific goggles during LLLT session to protect their eyes from laser. The goggles will also block red light and prevent the clinician from knowing whether the patient is receiving sham or real LLLT. The laser device will not be turned on until the eye protection is on both operator and patient. The device must be turned off prior to removal of eye protection. The Laser dosage and treatment details will be recorded in LLLT treatment sheet by the operator. Sham LLLT arm: Participants allocated to the sham LLLT arm will be treated using the same laser machine, but with the sham setting where the probe will not be emitting laser, but emitting a red light, which mimics the laser light. The patients receiving the sham treatment will be blinded to the treatment allocation. The machine will emit audible beeps when delivering either sham or real treatment, and as the participants will be unable to see anything through the eye shields there will be no perceptible difference between real and sham treatments. Clinical assessment will be done by appropriately trained research nurse/radiographer/clinician who will be blinded to whether the patient received LLLT or sham therapy. In Velindre, these assessments will be carried out during the patients’ routine radiotherapy review appointments by the review radiographer and/or consultant/SpR.
3.3 Design and theoretical/conceptual framework:
This is a triple blinded (intervention deliverer; assessor; patient) randomised placebo controlled trial. It tests the clinical and cost effectiveness of LLT in ameliorating the effects of irradiation to the head and neck primarily by means of a patient recorded outcome measure, namely the OMWQ-HN. Beyond this a mixed methods approach allows a comprehensive evaluation of this technology from patient and clinician perspective, allowing assessment of any benefit to the patient over and above the current standard of care, the ease of integration of this new therapy into existing care pathways, and cost effectiveness for patients and the national health service. Outcomes will also be assessed in the longer term, at 14 months. This design also addresses safety of LLLT in its application to HNC patients, by recording disease status up to 14 months from starting treatment.
3.4 Sampling
A total of 380 patients will be recruited from 7-10 head and neck cancer treatment centres across England and Wales. Potential sites were identified through the cancer research network based on the following criteria: i) a reasonable number of eligible patients annually ii) an identifiable site Principal Investigator, keen to devote personal time and energy to maximising recruitment. iii) capacity and willingness to introduce LLLT service. LiTEFORM sites (including Velindre) have successfully completed the NCTU Early Feasibility questionnaire on numbers of potential recruits, availability of staff and their willingness to train in a novel treatment.
It is planned to recruit 100 patients during the pilot phase of the trial. Subsequent to this and based on a recruitment rate of 230 patients per year, it should possible to recruit the remaining 280 patients during the 15 months following the pilot. We aim to recruit 20 patients in the 1st 12 months and 30 patients in the 2nd 12 months of the study at Velindre. This is feasible based on the annual number of head and neck patients treated at Velindre per annum (>200) and fact that a significant proportion of these patients (estimated 70%) will be receiving radiation to the oral cavity, either in the definitive or post- operative setting (both are eligible for the study, as long as they receive ≥ 60Gy ).
Patients will be randomised 1:1 to either LLLT or sham, in addition to standard care in both trial arms. The randomisation will be stratified by whether the patient receives radiotherapy alone or radiotherapy in combination with chemotherapy. The sequence generation will be arranged by Newcastle CTU, with advice from the Trial Statistician. Patients, clinicians and assessors will be blind to the treatment allocation.
Based on 190 patients in each trial arm and assuming a maximum of 20% drop-out or missing data, there would be 90% power to detect a 4-point difference between trial arms in the primary outcome measure, i.e. OMWQ-HN score at 6 weeks following start of irradiation, assuming a standard deviation of 10.7and based on a 2-sided test at the 5% level. According to previous work (Epstein), a group difference of 4 points would reflect a meaningful treatment effect.
4 Financial Impact:
Page 5
6 [Report Title]
The LITEFORM study is a UK portfolio study funded by the HTA. Costs of purchasing the LLLT equipment are not covered by the study budget and are therefore requested from Charitable Funds. In addition, funding is requested for radiographer time to deliver the LLLT to patients recruited to the trial.
4.1 Capital costs for Thor laser 1. Thor LX2 Control Unit 2. 660 nM 75 mW Dental Tip Inta oral. 3. 2 x Dual wavelength Protective Glasses 4. Soft carry Case £4,150
1. Sham / Placebo function £1,200
Total: £5,350 plus vat @20% = £6,420
[Quote provided by Mark Bruin @ thorlaser on 30/08/2016 – this is a reduced rate agreed for all study centres].
Extra safety glasses £110 plus vat @20% = £132
4.2 Maintenance costs of Thor laser:
Thor do not have a formal maintenance contract but have advised that a budget of £250 per year will cover maintenance of the laser.
Total: £500
4.3 Staffing costs
Patients will receive 3 sessions per week of LLLT, lasting 20-30min/session, delivered shortly before or after their (chemo)radiotherapy sessions for 6 weeks.
We will aim to recruit 20 patients in the 1st 12months (including 9 month pilot phase) and 30 patients in the 2nd 12 months of recruitment (15 months following pilot phase).
Total time required to deliver LLLT: 3x30min per week = 90min per patient per week x6= 540min or 9hrs per patient over 6 weeks
For 20 patients= 9hrsx20= 180hrs = 0.595hrs/day* ~3hrs/week
For 30 patients= 9hrsx30= 270hrs = 1.07hr/day* ~ 5.35hrs/week
*Based on 252 working days per annum (weekends and bank holiday/public holidays not included)
LLT will be delivered by Band 7 Velindre radiographers. Costs for mid-scale Band 7 radiographer (including ‘on-costs’ [pension & NI] provided by Kieran Gingell, Velindre Finance dept 31/08/2016) = £23.18 per hour.
Staff costs for Year 1= £4,172.4 Staff costs for year 2= £6,258.60
Total staff costs: £10,431
Staff training on how to deliver LLLT will be provided by trial team free of charge. A budget of £1000 is requested to cover travel for the PI and 4 radiographers to attend the study launch meeting.
4.4 Total costs:
Year 1: £6,420+ £132+£250+£4,172.40+£1000 = £11,974.40
Year 2: £250+ £6,258.60 = £6,508.60
Page 6
7 [Report Title]
5 Quality, Equality, Safety and Patient Experience Impact:
5.1 Patient Experience: Oral mucositis has a profound effect on patient QOL during and after head and neck radiotherapy – LLLT could potentially reduce mucositis, thereby benefitting patients who taken part in the study. If proven to be effective, it is also likely to be adopted into standard of care in the UK and internationally, benefitting future patients who undergo radiotherapy.
5.2 Quality and Equality
Participation in the LITEFORM study will give Velindre patients an opportunity to participate in a peer reviewed, portfolio adopted, UK clinical trial. Recruitment to clinical trials is a quality measure which is included in the Cancer Delivery Plan for Wales.
5.3 New development/opportunity for patients and staff
Setting up LLLT delivery for the LITEFORM study represents a new development for Velindre, which has the support of head and neck clinicians, the radiotherapy department (Jane Mathlin/Bernadette McCarthy) and the radiotherapy protection service (represented by Medical Physics Expert, Matthew Ager). A meeting has been held between these parties and there are ongoing discussions to clarify how we will set up LLLT as a new development within Velindre. Furthermore, we have met with Sarah Townsend, Velindre R&D manager, who is supportive of this new development (LLLT) and associated research study (LITEFORM).
LLT will be delivered by Band 7 Velindre radiographers and a number have already expressed an interest in developing their roles to deliver LLLT. It is envisaged that 4 radiographers will be trained to deliver LLLT. They will rotate under supervision from Jane Mathlin and Bernadette McCarthy.
Matthew Ager is enthused by the prospect of the addition of laser techniques to the repertoire of available therapies within the Trust and has offered his assistance. In order to satisfy the laser safety aspects of the development, he will provide the following:
• Develop corporate Artificial Optical Radiation Safety Policy • Develop Local Rules document • Complete a prior risk assessment for the application of lasers in the allocated room(s) • Provide requisite warning signs for the doors to the allocated treatment room(s) • Provide BMLA approved Core of Knowledge Laser Safety Training • Provide onsite Laser Protection Adviser (LPA) services • Review all associated clinical and non-clinical documentation • Acceptance inspection of equipment (including personal protective equipment (PPE)) on delivery (post-installation)
He will also train staff in the laser safety aspects of the therapy.
If the LITEFORM study proves to be positive, then our aim will be to set up LLLT as a service for Velindre patients. As far as we are aware, this service is not available to patients elsewhere in Wales.
6 Considerations for Board / Committee:
The Charitable Funds Committee are asked to support the business case for purchasing the LLLT equipment and radiographer costs to deliver the therapy to patients.
This development and associated research study will be good for patients, staff development at Velindre and will demonstrate the feasibility of developing therapies at Velindre, in conjunction with support from Charitable Funding.
7 Next Steps:
If the bid is approved by the Charitable Funds Committee, we will purchase the Thor laser required to deliver LLLT. In parallel, we will work with Matthew Ager of the Radiation Protection Service to set up the documents/policies and procedures, along with a dedicated room, to deliver this therapy at Velindre. We will also liase with the Newcastle Clinical Trials Unit to track study progress through central regulatory approvals and ensure that we are in a position to open the pilot phase of the study in a timely way at Velindre (likely in q1-2 2017).
Page 7
VELINDRE NHS TRUST CHARITABLE FUNDS
BUSINESS CASES REPORT TO BE SUBMITTED TO THE CHARITABLE FUNDS COMMITTEE
This document has to be completed for projects/ grants / bids with expenditure over £5,000
1.- BUSINESS CASE TITLE:
LITEFORM study: Low Level Laser Therapy for Oral Mucositis in Head & Neck Cancer.
2.- BUSINESS CASE PREPARED BY:
Mererid Evans
3.- BUSINESS CASE SPONSORED BY:
Andrea Hague
4.- UNIQUE BUSINESS CASE 5.- PROPOSAL TOTAL NUMBER EXPENDITURE:
(Requested from Corporate Management Accountant / HQ) :
2019/20 £18,483
6.- FUND NAME: 7.- FUND NUMBER:
(Requested from Corporate Management (Requested from Corporate Management Accountant / HQ) Accountant / HQ) Head and Neck/Thyroid 6310
8.- FUND BALANCE & CURRENT COMMITTMENTS:
(Requested from Corporate Management Accountant / HQ) Fund Actual Balance Opening Forecasted Current Forecasted as at Balance Income Committments Balance 31/08/2016 01/04/2016 2016/17 2016/17 31/03/2017
Head Neck/Thyroid 93,559.00 95,647.00 £ 3,950.00 -£ 14,256.00 85,341.00
There is adequate funding to cover this Business Case. Proposed expenditure for 2017-18 not yet finalized.
Lay Summary (added at request of the Operational Management Group)
Radiotherapy can cure many patients with Head and Neck cancer but can cause extremely serious side-effects. One of the most distressing side-effects is pain and ulceration in the mouth and throat (oral mucositis) which has a negative impact on patients’ quality of life and ability to eat and drink; it is one of the reasons that Head and Neck cancer patients are frequently admitted to hospital during their course of radiotherapy.
Low-level Laser Therapy (LLLT) uses laser light therapy to reduce ulceration, inflammation and pain. There is some evidence that it can help relieve some of the symptoms of oral mucositis during radiotherapy. However, we need better evidence that it is effective before it can be rolled out across the NHS and so the LITEFORM study has been set up in the UK to prove how effective it really is. LITEFORM is a randomized clinical trial which is being set up in 7-10 UK sites and Velindre has been chosen as one of those sites, based on our track record in other trials. We aim to recruit 50 patients to the study at Velindre over 2 yrs. During their radiotherapy, patients in the study will receive LLLT for 20-30mins, 3 times a week, for 6 weeks. Patients will be assessed as usual during radiotherapy in the radiotherapy review clinic.
In order to take part in the LITEFORM study, LLLT will be set up as a new development in Velindre. This has widespread support from the H&N SST, RT department, Radiation Protection Service and R&D Committee. Low level lasers are class 3b lasers meaning that they do not cut or burn, but may injure the eye. Therefore, LLLT will be delivered in a designated treatment room in the radiotherapy department, certified by our Laser Safety Officer, and patients and operators will wear eye shields or safety goggles. A team of radiographers will develop their roles to deliver LLLT and they will be trained to do so by the Laser Safety Officer and LITEFORM study team.
Developing LLLT at Velindre and taking part in the LITEFORM study provides our patients with access to a new treatment and the chance to take part in important research. If the study proves that LLLT reduces the pain and distress of oral mucositis, then we will make a case to set it up as a routine service in Velindre for future patients. The funding requirements to develop LLLT at Velindre (purchase of a Thor Laser and funding for radiographer time) are described in the business case.
9.- BRIEF DESCRIPTION OF PROPOSAL:
Almost 300 Head and Neck cancer patients receive high dose (radical) radiotherapy (RT) every year at Velindre Cancer Centre. Although, radiotherapy can effectively cure patients of their cancer, it can cause serious side-effects. One of the most significant acute (short-term) side-effects is oral mucositis which manifests as pain, inflammation and ulceration of the surface of the tongue and lining of the cheeks, floor of mouth and throat. It significantly affects the patients’ Quality of Life (QOL) and ability to eat and drink during and for up to 3 months after radiotherapy and is one of the factors contributing to the high admission rate and use of nasogastric/gastrostomy tube feeding for these patients.
Low-level Laser Therapy (LLLT) is a laser light therapy that improves tissue repair, reduces inflammation and reduces pain wherever the beam is applied. It requires local application, 2 or more times a week. LLLT works mainly on a protein in mitochondria (cytochrome c oxidase) to increase ATP and reduce oxidative stress. A cascade of mitochondrial and intracellular downstream effects lead to improved tissue repair and reduced inflammation. Low power density LLLT is used to promote healing and reduce inflammation. The international MASCC (Multinational Association Supportive Care in Cancer)/ISOO (International Society of Clinical Oncology) Evidence Based Clinical Practice Guidelines 2014 recommended using LLLT for prevention of oral mucositis in patients receiving haemopoietic stem cell transplantation +/- TBI (level evidence II) & suggested using LLLT for prevention of oral mucositis in patients undergoing Head and Neck RT (+/- chemotherapy) (level evidence III). However, robust prospective evidence of the efficacy of LLLT is lacking.
The LITEFORM study is a new phase III UK study, funded by the HTA and run by the Newcastle Clinical Trials Unit, which is being set up to prove whether LLLT can reduce the incidence and severity of oral mucositis in patients receiving head and neck radiotherapy. It is a randomized, placebo-controlled clinical trial which will randomly assign patients to receive either LLLT or placerbo (sham LLLT). It is triple blinded, which means that neither the patient, the operator (Velindre radiographer) or assessor (Velindre clinician or radiographer) will know if the patient has received LLLT or placerbo. In this way, the study will be able to determine if LLLT works to reduce oral mucositis in an unbiased way.
The study is being set up in 7-10 UK sites and Velindre has been chosen as one of those sites, based on our track record of recruiting to head and neck clinical trials and our research infrastructure. There will be an initial feasibility phase with ‘fast-track’ start-up (over 3 months) followed by recruitment of 100 patients in 9 months. The total UK recruitment target is 380 patients over 2 yrs. In Velindre, we aim to recruit 50 patients over 2yrs (20 patients in year 1, 30 patients in year 2). Patients will receive standard of care radiotherapy, 60-66Gy in 30 fractions over 6 weeks. Once consented to the study, they will be randomized 1:1 to LLLT or sham therapy. Treatment is given for 20-30mins, 3 times a week, during the 6 weeks of RT. It will be delivered by trained radiographers in a dedicated room in the RT department, certified by the Laser Safety Officer. The patient and operator will wear protective eye shields/goggles. RT-related toxicities will be collected in the RT review clinic (as per our current practice) by a clinician/another radiographer. The patient, operator and assessor are blinded to study allocation.
In order to take part in the LITEFORM study, LLLT will be set up as a new development in Velindre, in the context of this clinical trial. This is supported by clinicians (consultant members of H&N SST), RT department (represented by Jane Mathlin), Radiation Protection Service (represented by Matthew Ager) and R&D Committee. Low level lasers are class 3b lasers meaning that they do not cut or burn, but may injure the eye. LLLT will be delivered in a designated treatment room, certified by the Laser Safety Officer. The patient will wear adhesive eye shields and operators will wear safety goggles. Our operators will receive training from the local Laser Safety Officer and from and from LITEFORM study team.
10.-REASONS FOR PROPOSAL:
Provide in this section the reason for making the proposed changes. In particular, it should be indicated if they have an urgent clinical risk or if they are considered to be a “spend Save” initiative. You should ensure that these reasons:
• Are consistent with the Charitable Funds objectives, aims, and values. • Assist the Charitable Funds in moving towards its strategic vision. • Are identified as a priority within the Charitable Funds strategic and financial framework. • Assist the Charitable Funds in implementing external policies, plans, and reports.
Developing LLLT at Velindre and taking part in the LITEFORM study provides our patients with access to a new therapy (currently, to our knowledge, only available in one other RT unit in the UK outside of the trial centres) and the opportunity to participate in cutting edge clinical research. If the LITEFORM study proves that LLLT reduces the severity of oral mucositis during head and neck radiotherapy, we will make the case for setting up a LLLT service in Velindre to reduce the side- effects that are experienced by our future radiotherapy patients.
11.- BENEFIT / IMPACT OF PROPOSAL:
Indicate the anticipated benefits and impact of the proposed project:
• Benefit to patients of having access to new therapies (some patients are already asking for LLLT) and opportunities to participate in research • Reputational importance of taking part in high impact UK clinical studies • Reputational importance of developing new therapies for Velindre patients • Benefit to staff development – Jane Mathlin has already recruited a team of 4 radiographers who are interested in developing their roles to deliver LLLT. Such initiatives are important for retention and recruitment of staff.
12.- LIST OF OPTIONS CONSIDERED AND PREFERRED OPTION:
There are no other options apart from not developing LLLT at Velindre and not taking part in the LITEFORM study.
13.- RISK ASSESSMENT:
Indicate how the project will manage both strategic and operational risks identified as part of the risk assessment. In particular, you should make reference to risks which initiate the need for change, those which need to be managed in implementing the project and the risks identified with not proceeding with the project:
Setting up LLLT delivery for the LITEFORM study represents a new development for Velindre and the addition of laser techniques to the repertoire of available therapies within the Trust is supported by many departments (clinicians, radiotherapy, radiation protection and R&D). New developments are important for the Trust and expand the range of available therapies available for our patients. Participation in the LITEFORM in the early (pilot) phase will also enhance the reputation of the Trust for research.
Failure to deliver on our commitment to the LITEFORM study in a timely way and/or failure to recruit sufficient patient numbers is a risk. Allocation of a research radiographer to the study (pending new appointments) is critical to ensure this does not happen.
Lack of capacity within the RT department to deliver LLLT is a risk. This is minimised by requesting specific, additional funding in this business case for radiographer time to deliver LLLT, 3 times a week for the duration of RT, for every patient recruited to the study.
14.- COMPLIANCE:
Provide evidence that the proposed project meets the relevant requirements/standards including Health and Safety regulation, Legislation (e.g. Human Rights, Data Protection), Clinical Governance requirements, National Service Frameworks, NICE Regulations, Welsh Risk Management Standards, Commission for health improvement requirements and the Strategic and Financial Framework.
The LITEFORM study has been approved for funding by the HTA and its aims are supported by the NCRI Head and Neck Clinical Studies Group. It has received full support from Velindres’ R&D Department.
Setting up LLLT delivery for the LITEFORM study represents a new development for Velindre, which has the support of head and neck clinicians, the radiotherapy department (Jane Mathlin/Bernadette McCarthy) and the radiotherapy protection service (represented by Medical Physics Expert, Matthew Ager). The radiation protection service will provide laser safety training and provide the following documents to satisfy the laser safety aspects of the development:
• Develop corporate Artificial Optical Radiation Safety Policy • Develop Local Rules document • Complete a prior risk assessment for the application of lasers in the allocated room(s) • Provide requisite warning signs for the doors to the allocated treatment room(s) • Provide BMLA approved Core of Knowledge Laser Safety Training • Provide onsite Laser Protection Adviser (LPA) services • Review all associated clinical and non-clinical documentation • Acceptance inspection of equipment (including personal protective equipment (PPE)) on delivery (post-installation)
15.- R&D APPROVAL:
If required, please provide evidence that this project has been approved by the R&D Committee.
The project was presented to the R&D committee by Dr Mererid Evans on 21/09/2016. This confirmation of R&D support was received by E-mail on 06/10/2016 (with full letter of support to follow):
“Re: LITEFORM study: Low Level Laser Therapy for Oral Mucositis in Head & Neck
In reference to the above business case presented to the R&D Committee on the 21st September 2016, on behalf of the Committee I am writing to confirm full support for this project as described.
The Committee agreed to support the business case as presented and VCC Charitable Funds Committee will be notified of this decision.
We wish you every success with your project.
Yours sincerely
Dr Zoë Harris, Assistant Director of Research & Development”
16.- FUNDING REQUIREMENTS:
Provide here an indication of the anticipated costs for the whole project. This should include breakdown of Capital or Revenue costs. Within the revenue cost you should indicate Staff costs, Non-staff cost and Equipments
Description Staff Non Staff Capital Total Expenditure Expenditure Expenditure Expenditure Thor laser £6,420 £ 6,420.00 Extra safety goggles £132 £ 132.00 Mainenance of laser £500 £ 500.00 Staff training £1,000 £1,00 Band 7 Radiographer time £10,431 £ 10,431.00 Total £ 10,431.00 £ 1,500.00 £ 6,552.00 £ 18,483.00
The LITEFORM study is a UK portfolio study funded by the HTA. Costs of purchasing the LLLT equipment are not covered by the study budget and are therefore requested from Charitable Funds. In addition, funding is requested for radiographer time to deliver the LLLT to patients recruited to the trial.
Capital costs for Thor laser
1. Thor LX2 Control Unit 2. 660 nM 75 mW Dental Tip Inta oral. 3. 2 x Dual wavelength Protective Glasses 4. Soft carry Case 5. £4,150
1. Sham / Placebo function
£1,200
Total: £5,350 plus vat @20% = £6,420
[Quote provided by Mark Bruin @ thorlaser on 30/08/2016 – this is a reduced rate agreed for all study centres].
Extra safety glasses £110 plus vat @20% = £132
Maintenance costs of Thor laser: Thor do not have a formal maintenance contract but have advised that a budget of £250 per year will cover maintenance of the laser.
Total: £500
Staffing costs: Patients will receive 3 sessions per week of LLLT, lasting 20-30min/session, delivered shortly before or after their (chemo)radiotherapy sessions for 6 weeks. We will aim to recruit 20 patients in the 1st 12months (including 9 month pilot phase) and 30 patients in the 2nd 12 months of recruitment (15 months following pilot phase). Total time required to deliver LLLT:
3x30min per week = 90min per patient per week x6= 540min or 9hrs per patient over 6 weeks
For 20 patients= 9hrsx20= 180hrs = 0.595hrs/day* ~3hrs/week For 30 patients= 9hrsx30= 270hrs = 1.07hr/day* ~ 5.35hrs/week
*Based on 252 working days per annum (weekends and bank holiday/public holidays not included) LLT will be delivered by Band 7 Velindre radiographers. Costs for mid-scale Band 7 radiographer (including ‘on-costs’ [pension & NI] provided by Kieran Gingell, Velindre Finance dept 31/08/2016) = £23.18 per hour. Staff costs for Year 1= £4,172.4
Staff costs for year 2= £6,258.60
Total staff costs: £10,431 Staff training on how to deliver LLLT will be provided by trial team free of charge. A budget of £1000 is requested to cover travel for the PI and 4 radiographers to attend the study launch meeting.
Total costs:
Year 1: £6,420+ £132+£250+£4,172.40+£1000 = £11,974.40
Year 2: £250+ £6,258.60 = £6,508.60
17.- PROPOSE FUNDING CASH FLOW:
Indicate here the length of the project and the expenditure expected during the financial period.
Example - Year 1 Expenditure Total 2014/15 (April 2014-March 2015).
Please note that funding cannot be requested for more than a three years period.
The Total Funding Cash Flow should match the Total Funding Requirements indicated on the table above
Description Expenditure Expenditure Expenditure Total year 1 year 2 year 3 Expenditure Thor laser/goggles £ 6,552.00 £ 6,552.00 Maintenance £ 250.00 £ 250.00 £ 500.00 Training £ 1,000.00 Staff £4,172.40 6,258.60 £ 10,431.00 Total £ 11,974.40 £ 6,508.60 £ - £ 18,483.00 18.- FUNDING PROPOSAL:
Indicate here which fund or funds you are expecting to pay for this project / please, note that in order to request money from different restricted funds the project has to be strongly linked between the funds activities.
Funding is requested from the Head and Neck/Thyroid Fund 6310
This has been discussed and agreed by the H&N SST
19. TIMESCALE / PROJECT MILESTONES:
Indicate here the length of this project – This must include a start date and end date. (Please indicate if there is likely to be any lead time which may delay the start date).
The Thor laser will be purchased as soon as CFC funding is confirmed.
Staff laser safety training will start October 2016.
Development of documentation/policies will start Oct 2016.
We are awaiting confirmation from Newcastle CTU of when the start-up phase (3 months) of the LITEFORM study will start. Likely to be Q1 2017. Recruitment will start after this phase and is likely to continue for 21-24 months. Recruitment will be delayed if there is a delay in obtaining central/local R&D approvals during the start-up phase. Similarly, if there is a delay in preparing the documentation and policies necessary for to setting up LLLT delivery as a new development in Velindre.
20. PROJECT MANAGEMENT ARRANGEMENTS:
State the proposed arrangements for managing this project and list those who will be involved in the process.
Dr Evans will manage the project with input from:
Matthew Ager, Radiation Protection
Jane Mathlin, Radiotherapy and research radiographers (new posts currently being appointed)
Sarah Townsend, R&D
Regular meetings will be held to assess progress (6 weekly initially, then 3 monthly). We will report progress to the RT trials group and CFC.
21. Impact Assessment and Actions required when the project is Complete:
What will happen at the end of this project? State whether there is likely to be any further demands on the charity, or Velindre NHS Trust revenue accounts as a result of this proposal coming to an end and any action required to mitigate risks.
If the LITEFORM study proves to be positive (preliminary study results likely to be available 2019-2020), then our aim would be to set up LLLT as a service for Velindre patients. As far as we are aware, this service is not available to patients elsewhere in Wales.
22. PROJECT SUCCESS MEASUREMENT:
Detail here what criteria will be used to measure the success of the project. The results will be gauged when completing the annual evaluation report
1. Purchase of Thor Laser by Velindre 2. Allocation and adaptation of designated room 3. Development of corporate Artificial Optical Radiation Safety Policy, Local Rules document and other documentation 4. Staff attendance at laser safety course and training in delivery of low level laser therapy 5. Timely opening of the LITEFORM study (‘fast-track’) at Velindre 6. Patient recruitment
23. FUND HOLDER APPROVAL Please confirm that the fund holder has supported this funding request prior to it being submitted to the CFC.
Confirmation received
Yes ( X ) No ( )
24. DATE SUBMITTED TO CFC
06 October 2016
Sections 25-26 to be completed by Corporate Finance following CFC meeting.
25. CFC APPROVAL
Yes ( ) No ( )
If yes date approved:
26. GRANT APPROVAL LETTER SENT
Yes ( ) N/A ( )
If yes, date sent:
Charitable Funds Committee
BUSINESS CASE FOR Phase 1 Clinical Trials
Meeting Date: 20/10/2016
Author: Dr Rob Jones
Sponsoring Executive Director: Andrea Hague Report Presented by: Rob Jones
Committee/Group who have received or (Delete as appropriate) considered this paper: • Charitable Funds Operational Management Group – Date: 20/10/2016
Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The Charitable Funds Committee is asked to APPROVE funding for the continued phase 1 trials as outlined in the enclosed business case.
This report supports the following Velindre NHS Trust Charity Objectives (please tick)
General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas. Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services. Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.” Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services, which will further the following aims; • The investigation of the causes of cancer and the prevention, cure, treatment and defeat of cancer in all its forms; • The advancement of scientific and medical education and research in topics related to cancer; and • The furtherance of any other charitable purpose for the relief of persons diagnosed with cancer. Welsh Blood Service - For any charitable purpose or purposes relating to the National Health Service wholly or mainly for the services of the Blood Transfusion Service in the area served by the Welsh Blood Service.
2 Business Case
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick)
Equitable and timely services
Providing evidence based care and research which is clinically effective Supporting our staff to excel Safe and reliable services First class patient /donor experience
Spending every pound well
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards
• Safe care • Dignified care • Staff & Resources
1. Introduction / Background
Page 2
3 Business Case
1.1. The strategic need for a phase 1 workforce has been previously outlined in the original business case and this was previously approved with funding initiated for a year period from April 2014-16, and subsequently extended to March 2017 with the addition of new posts to reflect increased activity.
One of the primary reasons for adopting the strategy and business case was to allow Welsh patients wishing participate in Phase 1 trials to get treatment in Wales as opposed to travelling to Oxford or London. It also provided an opportunity to further improve the profile of both Velindre and Wales in Cancer Research and to increase collaboration between research institutions within Wales to deliver translational cancer research projects.
Key success since the approval of the business case include;
a. A rapid expansion of phase 1 trial activity and the unit has regularly exceeded pre-set treatment and financial targets (see below for details).
b. Of the 10 trials currently open to recruitment 3 are led by Cardiff based Chief Investigators
c. We have attracted investment from a number of organisations including CRUK, Cancer Research Wales (CRW), the Experimental Cancer Medicine Centre (ECMC), Wales Cancer Research Centre (WCRC).
d. Global leading recruiter to ARADES phase 1 clinical trial which has led to a Lancet Oncology publication. Welsh patients were some of the first in the world to gain benefit from the drug (ODM-201) which is now in 2 Phase 3 trials recruiting 3000 patients from 800 centres.
e. We have also employed three clinical research fellows, two of which are studying for higher degrees with laboratory based translation research projects and the other looking at the patient experience in phase 1 trials.
We now wish to extend the business case until April 2019 by drawing together separate bids that have been submitted to support expansion of activity since 2014 into a single document.
1.2 Expansion of phase 1 activity 2011/12-2015/16;
As outlined in the original business case the treatment of patients in phase 1 trials is extremely complex and requires a huge time commitment, greater than that involved later phase trials, and significantly greater than that required for standard of care (see figure 1 below)
Page 3
4 Business Case
Because of the required time commitment, a highly trained staff infrastructure is required. This has expanded over the last 5 years due to the rapid expansion of trials (see below Fig. 2)
Page 4
5 Business Case
The expansion of the trial portfolio has also facilitated an increased opportunity for patient participation. The total number of patients on treatment within our trials is outlined in figure 3 below. Each bar represents the number of patients receiving trial treatment in any given month spanning from 2012- 16. Of the 10 studies currently open to recruitment 3 (FAKTION, FURVA, and FIESTA) are led by Welsh Chief Investigators.
From the outset we have been conscious of generating income through external grants and commercial income in order to offset our staff costs. This is in line with our desire to generate the partnership funding model outlined in the original business case. In this way we have aimed to reduce the requirement of VCC CF funds over time.
In order to achieve this we have developed a balanced trial portfolio to include commercial and non-commercial studies. This has allowed us attract funding grants from external sources such as CRUK, CRW, ECMC, and WCRC, which funds 2 WTE research nurses, 1.5 WTE clinical research fellows, and a 0.5 WTE project officer. In addition we set targets for trial related income from both commercial and non-commercial activity. Figure 4 outlines how we have outperformed our pre-defined income targets 2014-16.
Page 5
6 Business Case
Predictions versus performance of Early Phase in VCC for 2014-2015 & 2015-2016 By financial year (1st April – 31st March)
Income
£528,751
£340,000
£250,000 £200,000
2014-2015 2015-2016
Figure 4. Income gained from per patient payments and drug reimbursement.
2. Timing:
2.1. Given the success of the unit in delivering trial treatment over the last 2 ½ years we now wish to extend the funding of existing posts until April 2019.
3. Description: 3.1. This business case does not seek to incorporate additional posts at this point but simply consolidate what has already been approved and extend an underwritten agreement of funding for a core set of posts.
4. Financial Impact:
4.1. No additional posts required, but an extension of funding is being requested against a business case which is coming to an end in March 2017. This business case also supersedes another phase 1 business cases which had previously secured funding of £372,288 from the CFC. Therefore the additional fund request to the committee is a minimum of £167,276 (539,564 - 372,288) or a maximum of £567,276 ((539,564 + £400,000) - £372,288)) depended on commercial income.
5. Quality, Equality, Safety and Patient Experience Impact:
5.1. The activity considered by the Committee supports the objectives of the Charity as outlined below:
Page 6
7 Business Case
• General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas.
• Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services.
• Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.”
• Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services.
6. Considerations for Board / Committee:
6.1. Please refer to the full business case enclosed with this report. Option appraisals, impact assessments, financial assessment and consideration of risks have been explored within the business case to assist the Committee in their decision as to whether to approve this funding request. Prior to submission to the Committee, the business case has been considered by the Fund Holder and is supported. The Corporate Finance Department have confirmed that funding is available in respect of the fund identified.
7. Next Steps:
7.1. The Charitable Funds Committee are asked to APPROVE funding for the posts outlined in the enclosed business case
Page 7
8 Business Case
Appendix 1
VELINDRE NHS TRUST CHARITABLE FUNDS
BUSINESS CASE REPORT TO BE SUBMITTED TO THE CHARITABLE FUNDS COMMITTEE
THIS DOCUMENT HAS TO BE COMPLETED FOR PROJECTS / GRANTS / BIDS WITH EXPENDITUREOVER £5,000
1. BUSINESS CASE TITLE
Consolidation of current agreed business cases to support the ongoing development of the Phase 1 Clinical Trials Service at Velindre Cancer Centre
2. BUSINESS CASE PREPARED BY:
Dr Rob Jones –Phase 1 lead, VCC Dr Zoe Harris – Assistant Director of Research and Development Mrs Kay Wilson-Team Lead Early phase Mrs Nicola Hughes-VCC Finance
3. BUSINESS CASE SPONSORTED BY:
Andrea Hague – VCC Director
4. UNIQUE BUSINESS CASE NUMBER: 5. PROPOSAL TOTAL EXPENDITURE: (Requested from Corporate Management Accountant / HQ)
2017/16 £539,564 (previous approved £372,484) Additional request from charity Min £167,276 Max £567,276 depended on commercial Income.
6. FUND NAME: 7. FUND NUMBER: (Requested from Corporate Management Accountant / HQ) (Requested from Corporate Management Accountant / HQ)
General Purpose Fund 6000
8. FUND BALANCE & CURRENT COMMITTMENTS: (Requested from Corporate Management Accountant / HQ)
Fund Actual Balance Opening Forecasted Current Forecasted as at Balance Income Committments Balance 31/08/2016 01/04/2016 2016/17 2016/17 £000 31/03/2017 £000 £000 £000 £000
6000 - General 2,163 2,431 2,250 -3,249 1,432
Page 8
9 Business Case
9. BRIEF DESCRIPTION OF PROPOSAL:
We now wish to extend the business case until March 2019 by drawing together separate bids that have been submitted to support expansion of activity since 2014 into a single document.
10. REASONS FOR PROPOSAL: Provide in this section the reason for making the proposed changes. In particular, it should be indicated if they have an urgent clinical risk or if they are considered to be a “spend Save” initiative. You should ensure that these reasons: • Are consistent with the Charitable Funds objectives, aims, and values as well as supporting the values of the Trust. • Assist the Charitable Funds in moving towards its strategic vision. • Are identified as a priority within the Charitable Funds strategic and financial framework. • Assist the Charitable Funds in implementing external policies, plans, and reports.
Given the success of the unit in delivering trial treatment over the last 2 ½ years we now wish to extend the funding of existing posts until April 2019.
11. BENEFIT / IMPACT OF PROPOSAL: Indicate the anticipated benefits and impact of the proposed project:
To secure support to continue Phase 1 trial delivery to patients until March 2019
12. LIST OF OPTIONS CONSIDERED AND PREFERRED OPTION:
To consolidate the Phase 1 business cases
13. RISK ASSESSMENT: Indicate how the project will manage both strategic and operational risks identified as part of the risk assessment. In particular, you should make reference to risks which initiate the need for change, those which need to be managed in implementing the project and the risks identified with not proceeding with the project:
Both strategic and operational risks remain as per original business case. Actual income for the current financial year has proven successful in its overachievement. However the financial risk remains a constant due to the unpredictability of early phase research.
14. COMPLIANCE Provide evidence that the proposed project meets the relevant requirements/standards including Health and Safety regulation, Legislation (e.g. Human Rights, Data Protection), Clinical Governance requirements, National Service Frameworks, NICE Regulations, Welsh Risk Management Standards, Commission for health improvement requirements
Page 9
10 Business Case
and the Strategic and Financial Framework.
The projects compliance with requirements are detailed in the Business Justification approved by Trust R&D committee.
15. RESEARCH & DEVELOPMENT APPROVAL: If this project includes R&D activity, please provide evidence that this project has been approved by the R&D Committee e.g. date approved.
All activity and posts have been previously approved by R&D committee
16. FUNDING REQUIREMENTS: Provide here an indication of the anticipated costs for the whole project. This should include breakdown of Capital or Revenue costs. Within the revenue cost you should indicate Staff costs, Non-staff cost and Equipments
Consultants Sessions 2017-18 2018-19 R Jones 1 11,000 11,165 S Kumar 1 11,000 11,165 Radiology Sessions 2 22,000 22,330 Vacant 3 33,000 33,495 77,000 78,155 SPR 0.5 24,852 25,225 Research Fellow August 17 - March 18 1 38,000 0 Research Fellow March 18 - August 18 0 38,380 62,852 25,225 Band 7 Unit Manager 0.8 35,232 35,760 Band 6 Nurse 0.3 21,996 22,326 Band 6 Nurse 0.73 27,260 27,669 Band 5 Nurse 1 35,080 35,606 Band 4 Nurse 0.8 20,028 20,328 139,596 141,690 Band 6 R&D Officer 0 14,000 14,210 Band 5 Clerical 1 30,324 30,779 Band 4 Clerical 0.5 12,030 12,210 56,354 57,199 Band 8a Pharmacist 0.5 29,638 30,083 Band 5 Pharmacy Technician 0.5 16,231 16,474 Band 3 Pharmacy Tech 0.5 10,691 10,851 56,560 57,408
Education Fund 10,000 10,000
Clinical Research Fellow Project - 3 Years 1 59,671 67,854 Clinical Research Fellow Project - 3 Years Consumables 20,000 20,000
Subtotal of Posts 482,033 457,531
Page 10 11 Business Case
- - Projected Commercial Income 200,000 200,000
Total Funding 282,033 257,531
Funding already secured from outside of the Charity
Funded Posts Band 6 Nurse 1 37,759 Band 5 Clerical 1 26,946 Band 4 Clerical 0.5 12,030 Band 6 Nurse 0.5 21,996 CRW Fellow 49,704
148,435
No additional posts required, but an extension of funding is being requested against a business case which is coming to an end in March 2017. This business case also supersedes another phase 1 business cases which had previously secured funding of £372,288 from the CFC.
Therefore the additional fund request to the committee is a minimum of £167,276 (539,564 - 372,288) or a maximum of £567,276 ((539,564 + £400,000) - £372,288)) depended on commercial income.
17. PROPOSED FUNDING CASH FLOW: Indicate here the length of the project and the expenditure expected during the financial period. Example - Year 1 Expenditure Total 2014/15 (April 2014-March 2015). Please note that funding cannot be requested for more than a three years period. The Total Funding Cash Flow should match the Total Funding Requirements indicated on the table above
Description Expenditure Expenditure Expenditure Total year 1 year 2 year 3 Expenditure Phase 1 £ 282,033.00 £ 257,531.00 £ 539,564.00 £ - £ - Total £ 282,033.00 £ 257,531.00 £ - £ 539,564.00
18. FUNDING PROPOSAL Indicate here which fund or funds you are expecting to pay for this project / please, note that in order to request money from different restricted funds the project has to be strongly linked between the funds activities.
General Fund
Page 11 12 Business Case
19. TIMESCALE / PROJECT MILESTONES Indicate here the length of this project – This must include a start date and end date. (Please indicate if there is likely to be any lead time which may delay the start date).
** If a project has not commenced within six months of the approved start date then you will be requested to provide a progress update to the Charitable Funds Committee who will consider whether funding will continue depending on the explanation provided**
Given the success of the unit in delivering trial treatment over the last 3 ½ years we now wish to extend the funding of existing posts until April 2019.
20. PROJECT MANAGEMENT ARRANGEMENTS State the proposed arrangements for managing this project and list those who will be involved in the process.
The Senior Responsible Owner (SRO) for the project remains Dr Rob Jones
21. IMPACT ASSESSMENT AND ACTIONS REQUIRED WHEN THE PROJECT IS COMPLETE: What will happen at the end of this project? State whether there is likely to be any further demands on the charity, or Velindre NHS Trust revenue accounts as a result of this proposal coming to an end and any action required to mitigate risks.
The continuation and development of the Early Phase service is an ongoing aim of the Trust. Continued support is anticipated until the Service achieves its aim of becoming sufficient. However, the service will be subject to annual review and any subsequent funding proposal will be submitted to a future Charitable Funds Committee.
22. PROJECT SUCCESS MEASUREMENT Detail here what criteria will be used to measure the success of the project. The results will be gauged when completing the annual evaluation report
Continued development and growth of Phase 1 trial delivery to patients.
23. FUND HOLDER APPROVAL Please confirm that the fund holder has supported this funding request prior to it being submitted to the CFC.
Confirmation received Yes
Page 12 13 Business Case
24. DATE SUBMITTED TO THE CHARITABLE FUNDS COMMITTEE
SECTIONS 25-26 TO BE COMPLETED BY CORPORATE FINANCE FOLLOWING CFC MEETING.
25. CHARITABLE FUNS COMMITTEE APPROVAL
Yes ( ) No ( )
If yes, date approved:
26. GRANT APPROVAL LETTER SENT
Yes ( ) N/A ( )
If yes, date sent:
Page 13
CHARITABLE FUNDS COMMITTEE REPORT
BUSINESS CASE EVALUATIONS
Meeting Date: 8th November 2016
Author: Cally Hamblyn, Legal Services & Governance Manager Sponsoring Executive Director: Mark Osland, Executive Director of Finance & Informatics Report Presented by: Georgina Galletly, Director of Corporate Governance Committee/Group who have received or Charitable Funds Operational Management th considered this paper: Group – 20 October 2016.
Trust Resolution to: (please tick) APPROVE: REVIEW: INFORM: ASSURE: Recommendation: The Charitable Funds Committee is asked to NOTE this report.
This report supports the following Velindre NHS Trust Charity Objectives (please tick) General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas. Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services. Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.” Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services. Welsh Blood Service - For any charitable purpose or purposes relating to the National Health Service wholly or mainly for the services of the Blood Transfusion Service in the area served by the Welsh Blood Service.
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick) Equitable and timely services Providing evidence based care and research which is clinically effective Supporting our staff to excel Safe and reliable services First class patient /donor experience Spending every pound well ACRONYMS
OMG – Charitable Funds Operational Management Group
2 Business Case Evaluation Reports
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards
• Governance, Leadership and Accountability • Staff and resources • Individual Care • Effective Care • Dignified Care
Page 2
3 Business Case Evaluation Reports
1. Introduction / Background
1.1. In accordance with the process for applying for Charitable Funds, leads and/or sponsors are asked to provide an annual update or an evaluation (depending on the status) in respect of business cases which have been approved by the Charitable Funds Committee.
1.2. This process will inform and update the Charitable Funds Committee on how the approved funds have been used and what impact the proposals have had on the services provided.
1.3. The Evaluation Reports are considered by the OMG prior to being received at the CFC.
2. Timing:
2.1. The evaluations are requested on an annual basis until completion of the project.
3. Description:
3.1. See Appendix 1 – Evaluation Reports.
4. Financial Impact:
4.1. The financial implications are outlined in the Evaluation Reports included at Appendix 1.
5. Quality, Equality, Safety and Patient Experience Impact:
5.1. All business cases approved by the Committee are required to support the objectives of the Charity as outlined below:
• General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas.
• Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services.
• Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.”
• Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services.
6. Considerations for Board / Committee:
6.1. A programme for receiving the Evaluation reports has been established, the evaluations received for October 2016 are outlined in the table on page 4.
Page 3
4 Business Case Evaluation Reports
Business Case Proposal Comments Reference 2013/018 Non Medical With regard to the Research Project for the evaluation of Non Pharmacy Research Medical Research, the lead is currently on long term absence and therefore the research has been suspended for approx 12 months after which time the lead intends to pick the project back up. Progress to date: 1) Completed the first study and currently evaluating / writing up 2) In the process of gaining ethical consent for the second study.
Further update will be requested in January 2017.
2015-018 All Wales Cancer The position has not been appointed. So this has not Centre Clinical Trials progressed, at present as the lead has no candidates or Research fellowship applications. So this project currently remains on hold.
Further update will be requested in January 2017.
2015-019 VRRI RT Strategy Deferred to January 2017. A collective evaluation incorporating Research all the investment in Radiotherapy Research & Developments Infrastructure will be received at the next Committee meeting under the Moondance Radiotherapy Programme.
Further update will be requested in January 2017. 2016-012 Acute Oncology App Evaluation included at Appendix 1.
2016-020 VNHST Service Evaluation included at Appendix 1. Improvement Small Grant Scheme 2016-019 CRTU Funding - Evaluation included at Appendix 1. Pharmacy Staff 2016-021 Research Evaluation included at Appendix 1. Governance / Quality Assurance Officer Post 2016-016 Clinical Fellow in Evaluation to be deferred until next meeting as Lead is currently Gynaecological going to advert for this position. Lead was advised by the Technical RT Training Programme Director to delay interviewing to fit in with trainee exam timetables.
Further update will be requested in January 2017. 2016-03 Moondance Evaluation included at Appendix 1. Foundation Grant
7. Next Steps:
7.1 The Charitable Funds Committee is asked to NOTE this report.
Page 4
5 Business Case Evaluation Reports
Appendix 1
APPROVED BUSINESS CASES – ANNUAL EVALUATION REPORT
1. BUSINESS CASE TITLE: 2. BUSINESS CASE REFERENCE NUMBER
Service Improvement Small Grants Scheme 2016/20
3. BUSINESS CASE PREPARED BY: 4. BUSINESS CASE SPONSORED BY:
Dr Zoe Harris Assistant director of Research & Professor Susan Morgan, Executive Director of Development Nursing & Service Improvement Lisa Miller, General Manager, Velindre Cancer Centre 5. DATE APPROVED BY CFC: 6. DATE APPROVED BY R&D COMMITTEE
11th November 2015 N/A
7. BRIEF SUMMARY OF PROJECT:
• The Service Improvement Small Grants Scheme will be a competitive scheme. • The scheme is intended to support practical application of service improvement knowledge and skills acquired through participation in IQT silver or the Trust’s Leadership Development Programme. • £50,000 will be available each year for three years; the maximum individual award will be £10,000. • Funding can be used for staff time, backfill, consumables etc. • Projects must be completed within 12 months of commencement. 8. PROJECT TERM – i.e. one year
Three years
9. PLEASE INDICATE THE STAGE OF THE PROJECT THIS EVALUATION RELATES TO: (please tick)
Year 1 Year 2 Year 3 End of project evaluation 10. EXPENDITURE:
a) What was the value of the funding request?
£150,000 (£50,000 in yr1, yr2, and yr3) b) Is expenditure on target? If no, explain why?
On target but no expenditure to date (call for applications for yr 1 funding about to be issued).
Page 5
6 Business Case Evaluation Reports
11. IS THE PROJECT ON TARGET? IF THE PROJECT IS FINALISED WERE THE PROPOSALS DELIVERED WITHIN THE AGREED TIMESCALES?
Yes - some slippage with issue of call for applications but not anticipated to impact on timescale overall.
12. WHAT WENT WELL – HAS THE PROJECT MET THE ANTICIPATED BENEFITS?
N/A at this stage
13. WHAT DID NOT GO SO WELL? IDENTIFY ANY LESSONS LEARNED.
N/A at this stage
14. MEASURING SUCCESS
Embedding Service Improvement within the culture of Velindre will have multiple benefits to patients, staff, and the organisation.
• Provide a vehicle to embed SI within daily practice, promoting a culture of shared purpose and best practice as part of all staff working practices • Provide a valuable resource to further investigate important SI questions posed by the outcomes of the Transforming Cancer Services Programme. • Facilitate an increase in journal articles and conference presentations. • Provide job enrichment for the workforce through exposure to new skills and experiences, which will benefit both the individual and the organisations, and ultimately our other staff, patients and donors. • Enables colleagues who have engaged with in-house learning to access tangible support for continued learning and opportunity to further utilise their skills.
15. FEEDBACK
N/A at this stage
Page 6
7 Business Case Evaluation Reports
APPROVED BUSINESS CASES – ANNUAL EVALUATION REPORT
1. BUSINESS CASE TITLE: 2. BUSINESS CASE REFERENCE NUMBER
The Development of an Acute Oncology App 2016-012
3. BUSINESS CASE PREPARED BY: 4. BUSINESS CASE SPONSORED BY:
Dr Hilary Williams, Consultant Andrea Hague, Director Velindre Cancer Centre Philip Richards, IM&T Tom Crosby, Consultant
5. DATE APPROVED BY CFC: 6. DATE APPROVED BY R&D COMMITTEE
Not applicable
7. BRIEF SUMMARY OF PROJECT:
The lead requested funding to complete the development of an Acute Oncology App; they successfully applied to charitable funds to undertake a phased approach to the development with the first phase agreed in Feb 2015. However, following detailed discussions with the procurement team and initial exploratory discussions with potential IT providers, it is clear a single step procurement to complete the project is the preferred approach.
The aims of the APP remain the same, which is to exploit smart phone technology to enable rapid access to acute oncology guidelines and clinical teams with key clinical messages. In addition exploratory discussions with IT/App developers on the required NHS framework has allowed us to build a detailed specification for the project. A number of companies have prior experience of using creative design solutions in the health care setting, a key requirement to ensure pathways are easy to navigate by busy clinical teams.
A crucial challenge for VCC remains improving care for our patients who receive treatment at VCC, but due to geography or bed availability are admitted to local hospitals or present to local community teams with life threatening toxicities. The APP, particularly aimed at front line junior staff, will allow universal access to succinct emergency protocols and ultimately improve compliance with critical clinical pathways. It will be free across mobile platforms and will not be limited by need to access the internet or NHS computers. 8. PROJECT TERM – i.e. one year
Aim to complete March 2017.
9. PLEASE INDICATE THE STAGE OF THE PROJECT THIS EVALUATION RELATES TO: (please tick)
Year 1 Year 2 x Year 3 End of project evaluation 10. EXPENDITURE:
c) What was the value of the funding request?
Page 7
8 Business Case Evaluation Reports
£46,218.00 for the development and first year fees, plus £6000 for year 2 and 3 support and maintenance. Potential total over three years - £52,218 excluding VAT Amount was agreed following completion of the procurement process. 11. IS THE PROJECT ON TARGET? IF THE PROJECT IS FINALISED WERE THE PROPOSALS DELIVERED WITHIN THE AGREED TIMESCALES?
Completed the procurement process on digital cloud and appointed the provider (26 Digital.)
Finalised the APP clinical pathways and agreed the project plan/time scales.
The App build should start in October 2016 and deliver IOS platform in January 2017 with android platform in March 2017.
12. WHAT WENT WELL – HAS THE PROJECT MET THE ANTICIPATED BENEFITS?
N/A as yet
13. WHAT DID NOT GO SO WELL? IDENTIFY ANY LESSONS LEARNED.
Learning in respect of the complexities of NHS procurement, buying a digital solution (rather than a piece of kit) & the digital procurement platforms (G cloud and digital services framework).
14. MEASURING SUCCESS
Excellent and enthusiastic support from a wide range of clinical teams across Wales. The lead has 15 acute oncology protocols which are agreed on an All Wales basis and aimed at acute and community teams.
15. FEEDBACK
N/A until completion
Page 8
9 Business Case Evaluation Reports
APPROVED BUSINESS CASES – ANNUAL EVALUATION REPORT
1. BUSINESS CASE TITLE: 2. BUSINESS CASE REFERENCE NUMBER
CLINICAL RESEARCH TREATMENT UNIT: 2016-019 Continuation of Funding to support clinical trials activity undertaken by Pharmacy. 3. BUSINESS CASE PREPARED BY: 4. BUSINESS CASE SPONSORED BY:
Bethan Tranter – Chief Pharmacist Andrea Hague – Director VCC Jon Patmore – VCC Finance Manager 5. DATE APPROVED BY CFC: 6. DATE APPROVED BY R&D COMMITTEE
7. BRIEF SUMMARY OF PROJECT:
In January 2014, the Charitable Funds Committee approved funding to support £158,000 of staff costs for the Clinical Trials Research Unit (Non Phase 1) for 1 year. The proposal stated that subsequent years’ funding would be subject to further proposals.
This proposal sought to support to continue that funding for a further 3 year period. It is understood that in the longer term funding streams for clinical trial staffing resources will be addressed at a Trust/ Cancer Centre and that this will include the pharmacy element.
This report is specifically for the Pharmacy staff element.
Supporting these posts will enable the Clinical Research Treatment Unit to give patients continued access to the current level of high quality trials which includes trials; and novel therapies, vaccines and Phase II, III and IV trials
This funding proposal is for continuation of funding for 3.0 WTE Pharmacy staff
8. PROJECT TERM – i.e. one year
3 years
9. PLEASE INDICATE THE STAGE OF THE PROJECT THIS EVALUATION RELATES TO: (please tick)
Year 1 Year 2 x Year 3 End of project evaluation 10. EXPENDITURE:
d) What was the value of the funding request?
£94k per annum
Page 9
10 Business Case Evaluation Reports
e) Is expenditure on target? If no, explain why?
Yes 11. IS THE PROJECT ON TARGET? IF THE PROJECT IS FINALISED WERE THE PROPOSALS DELIVERED WITHIN THE AGREED TIMESCALES?
Yes
12. WHAT WENT WELL – HAS THE PROJECT MET THE ANTICIPATED BENEFITS?
Funding these posts has enabled Pharmacy to continue the team based working for clinical trials and build on our success from previous years. We have excellent working relationships with CTU and other departments. We have continued to comply with the required GCP standards to take on the numerous activities required for pharmaceutical input into clinical trials.
Such activities include: • Meeting with Sponsors for initial evaluation visits and subsequent site initiation visits • Reviewing and advising on whether a prospective clinical trial is suitable and financially viable to run at VCC, and active involvement in the Trials Operational Group • Preparing, writing and inputting information for all pharmacy related documents required for managing the trial according to Good Clinical Practice (GCP • Ongoing active involvement in external groups (TMGs and CRUK project) • Dispensing and clinical checking of trial prescriptions according to GCP and protocol requirements • Management of Clinical Trial Investigational Medicinal Products (CTIMPs) according to GCP requirements (to include stock control, archiving, temperature monitoring, clerical) • Hosting external representatives of the Sponsor during their routine frequent monitoring visits. Currently averaging 12 per month • Updating pharmacy documents and prescriptions in a timely manner for numerous protocol amendments every month.
13. WHAT DID NOT GO SO WELL? IDENTIFY ANY LESSONS LEARNED.
Not applicable.
14. MEASURING SUCCESS
Having a dedicated pharmacy clinical trials team ensures that processes are streamlined efficiently, and with very few errors occurring
Pharmacy are meeting the demand, and are on target, for new trials reviewed and set up at VCC; and similarly for ongoing protocol amendments
Page 10 11 Business Case Evaluation Reports
Even though pharmacy haven’t measured patient experience per se, our aim is to streamline processes to make the service patient centred and reduce waiting times as far as possible. We dispense many trial prescriptions per month and having a specialized team to dispense these complex prescriptions (rather than the prescription being absorbed by the pharmacy department mixed amongst all their other work) has enabled an efficient service with a very low error rate.
The graphs below show our dispensing workload
Page 11 12 Business Case Evaluation Reports
Figure 1 shows that the trend in number of trials being opened is increasing. However, the number of dispensings (or number of patients recruited) isn’t increasing at the same rate (figures 2 and 3) The main reason for this is that the types of new trials today are significantly different to even just four or five years ago. Research has moved on at a substantial pace and the large recruiting trials of previous years have gone and the trials being opened now are more complex with targeted therapies which will not recruit the large numbers that they have done in the past. This is in line with prediction statements made by the Research and Trials workstream of Transforming Cancer Services
The average time in August 2016 to dispense an oral trial prescription is 15 minutes. This is well over half of the previous times before we adopted the team approach and is a reflection of having named staff to undertake this workload.
We have received positive external monitor reports and no issues have been noted. This again is a reflection of team working.
15. FEEDBACK
Positive verbal feedback from CTU, CRTU and R&D departments
Page 12 13 Business Case Evaluation Reports
APPROVED BUSINESS CASES – ANNUAL EVALUATION REPORT
1. BUSINESS CASE TITLE: 2. BUSINESS CASE REFERENCE NUMBER
Request for extension to part funding of Research 2016-021 Governance Officer/Quality Assurance Post
3. BUSINESS CASE PREPARED BY: 4. BUSINESS CASE SPONSORED BY:
Sarah Townsend, Research & Development Professor Peter Barrett-Lee, Medical Director Manager/Sponsor Representative
5. DATE APPROVED BY CFC: 6. DATE APPROVED BY R&D COMMITTEE
11th November 2015
7. BRIEF SUMMARY OF PROJECT:
To support the daily activities associated with • the management of the risk profile of research portfolio in respect of governance and sponsorship • ensuring that the Trust is compliant with national, UK and EU clinical trial regulations as required by the MHRA • Managing the relationship with Cardiff University (CU) Centre for Trials Research (CTR)
8. PROJECT TERM – i.e. one year
2 years
9. PLEASE INDICATE THE STAGE OF THE PROJECT THIS EVALUATION RELATES TO: (please tick)
Year 1 x Year 2 Year 3 End of project evaluation 10. EXPENDITURE:
f) What was the value of the funding request? 2015/16 = £8,793 2016/17 = £22,072 2017/18 = £13,485 Total £44,350 g) Is expenditure on target? If no, explain why?
Yes – Spend to date £13,030.
11. IS THE PROJECT ON TARGET? IF THE PROJECT IS FINALISED WERE THE PROPOSALS DELIVERED WITHIN THE AGREED TIMESCALES?
This post has been filled by 2 members of staff and the role continues to meet objectives set by the R&D Page 13 14 Business Case Evaluation Reports
Manager/Sponsor Representative to assist in the maintenance of the current risk profile of the Trust in respect of regulatory requirements, particularly in relation to the conduct of Trust sponsored studies, many of which are hosted UK wide.
12. WHAT WENT WELL – HAS THE PROJECT MET THE ANTICIPATED BENEFITS?
Yes. The role continues to ensure high standards of governance, as described within the Feedback section.
13. WHAT DID NOT GO SO WELL? IDENTIFY ANY LESSONS LEARNED.
None at this time
14. MEASURING SUCCESS
• Development and implementation of process to manage the R&D risk register and DATIX system • Positive feedback from external agencies and institutions (see below) • Low risk rating applied by MHRA direct response to high standards of governance through the establishment of the role, which results in less frequent inspections and a reduced cost burden.
15. FEEDBACK
• The UK NIHR Health Technology Assessment (HTA) programme, who fund 40% of the role, have previously highlighted that the post is considered best practice in the management of sponsor responsibilities. • Senior Staff within the CTR fully support the role and consider it to be value added to both VNHST and CU.
Page 14 15 Business Case Evaluation Reports
APPROVED BUSINESS CASES – ANNUAL EVALUATION REPORT
1. BUSINESS CASE TITLE: 2. BUSINESS CASE REFERENCE NUMBER
Moondance Foundation Grant 2016/13
3. BUSINESS CASE PREPARED BY: 4. BUSINESS CASE SPONSORED BY:
Dr Tom Crosby, Consultant Clinical Oncologist, Andrea Hague, Director Velindre Cancer Centre Velindre Cancer Centre 5. DATE APPROVED BY CFC: 6. DATE APPROVED BY R&D COMMITTEE
12th August 2015 8th September 2015
7. BRIEF SUMMARY OF PROJECT:
Velindre Cancer Centre (VCC) has been developing its Radiotherapy R&D Strategy which it has referred to as Cutting Edge Radiotherapy Project. The ultimate aim of this strategy is the establishment of a Velindre Radiotherapy Research & Development Institute (VRRI). These well established ambitions are contained within the Trust strategic transforming project “Transforming Cancer Services in SE Wales”, where the goal is to establish VCC as the best Cancer Centre in Europe over the next 10 years.
An award made by the Moondance Foundation, and subsequently the CFC, support this move towards establishing a VRRI. The Programme will create a research and service development infrastructure which accelerates the introduction of stereotactic treatment for patients. This will be achieved by establishing a multi-disciplinary team who can drive forward this cutting edge radiotherapy research; provide staff, equipment and infrastructure to enable patients to receive Stereotactic Ablative Body Radiotherapy (SABR) routinely; and enable participation in clinical trials involving SABR.
Creating a research and service infrastructure will allow VCC to: • accelerate the introduction of stereotactic treatment for patients within funded indications, the Commissioning through Evaluation scheme and clinical trials; • Support the infrastructure to apply for research grants and awards such as the CRW Programme Grant • Support a wider advanced radiotherapy development programme
The benefits of this programme of work will: • help develop a research and development infrastructure for radiotherapy which is a priority with Trust R&D Strategy • allow VCC to develop radiotherapy and ensure it can be an early adopter of new techniques through advanced development of expertise i.e. be at the forefront of UK Radiotherapy Research and Service Development • embed the infrastructure to support new capital equipment application to Welsh Government • make provision of an infrastructure to provide quality improvement and prudent healthcare • enable VCC staff to develop and train its workforce in the latest techniques, thereby aiding recruitment and retention; and • provide patients in SE Wales with access to state of the art radiotherapy and thereby improve outcome for patients
8. PROJECT TERM – i.e. one year Page 15 16 Business Case Evaluation Reports
Five years
9. PLEASE INDICATE THE STAGE OF THE PROJECT THIS EVALUATION RELATES TO: (please tick)
Year 1 X Year 2 Year 3 End of project evaluation 10. EXPENDITURE:
h) What was the value of the funding request?
£1,500,000 This was funding to match that initially awarded by the Moondance Foundation (therefore a project budget of £3,000,000 in total).
i) Is expenditure on target? If no, explain why?
The overall expenditure is on target, with £1.5m committed. Drawing down on these costs will be spread over the five years of funding.
11. IS THE PROJECT ON TARGET? IF THE PROJECT IS FINALISED WERE THE PROPOSALS DELIVERED WITHIN THE AGREED TIMESCALES?
The overall project is on target, and with newly appointed clinical and administrative help, individual projects will be monitored over the life of the funding.
12. WHAT WENT WELL – HAS THE PROJECT MET THE ANTICIPATED BENEFITS?
The Moondance Programme Board was established and first met in February 2015. It is Chaired by non- executive member Jan Pickles, with Tom Crosby as the Moondance Programme Clinical Lead, and a membership of: Andrea Hague, Director VCC; Jacinta Abraham, Clinical Director VCC; Mark Osland, Director Finance VNHST; Jenny Stock, Radiotherapy Project Manager.
The Moondance Programme Board is advised and guided on applications by comments and queries provided by an Advisory Group. The membership of this includes clinical and operational representatives; and expertise from R&D, Nursing and Finance.
The Board now has appropriate governance, process and procedures in place. It has also set out a strategic proposal for the funds which closely align with the Moondance objectives and the radiotherapy strategy. Appointments have yet to be made to the Clinical Lead and Programme Manager post. Expert advice, and close monitoring and support will then in place for lead applicants to draw on.
A complete summary of awarded projects can be found in Appendix A. The evaluation of these projects will provide greater detail over the coming months, however for now, the following are the key achievements of some of the funded bids:
• The PET-based Adaptive Radiotherapy Clinical Trial (PEARL) research proposal has been awarded a matched fund of £380k from Cancer Research Wales (CRW).
• Funding clinical time dedicated to leading the clinical implementation of Stereotactic Body Radiation Therapy (SBRT), has seen the establishment of the new stereotactic MDT which is now evaluating all patients referred for stereotactic treatment. Page 16 17 Business Case Evaluation Reports
• A fellowship award has meant one of VCCs registrars is in Canada studying SABR practices to bring back and expand the SABR service.
• Access to SABR has been extended to patients (with medically inoperable early stage lung cancer) in South West Wales.
• A Radiomics event (17 March 2016) in collaboration with CRW, and the Annual South Wales Radiotherapy Review meeting will be held in December 2016.
As a result of the above, the following benefits have started to be realised: • a research and development infrastructure for radiotherapy is beginning to emerge • opportunities for VCC staff to develop and train in the stereotactic service (clinical oncologist and medical physics time have been awarded, with a proposal for radiotherapy in the next round of applicants) • provide patients in SE Wales (and SW Wales) with access to state of the art radiotherapy and thereby improve outcome for patients
13. WHAT DID NOT GO SO WELL? IDENTIFY ANY LESSONS LEARNED.
The application evaluation process has evolved and part way through an external peer review process was implemented to ensure appropriate scrutiny on the research is being undertaken. It would have been preferable to have this in place from initiation.
14. MEASURING SUCCESS
Success of the Moondance Programme will: • Accelerate implementation of stereotactic radiotherapy programme • Achieve matched funding from CRW • Patient outcomes and treatment rates will be reported accurately and appropriately through the accurate recording of data and follow up • Benchmark VCCs use of stereotactic treatments against all treatment routes and against other leading centre in the UK • Effective partnership working with academic institutions, charities and other research funds • Publish academic papers • Provide support for areas of advanced radiotherapy for the wider benefit of patients • Support for meetings • Training and support
15. FEEDBACK
N/A
Page 17 18 Business Case Evaluation Reports
Appendix A - Moondance Programme - Awarded Applications
Date Amount Application Description Approved Awarded Consultant post to lead the clinical implementation of SBRT at VCC: expand, audit Consultant Clinical Lead for 17/02/16 & evaluate services (inc long term outcomes); £140,000 Stereotactic Radiotherapy coordinate a MDT; education and training; clinical trials for SABR Training opportunity to learn and experience McGill University Stereotactic SABR where it is well established in North 17/02/16 £35,000 Ablative Fellowship America (currently no UK centres that have extensive experience of SABR provision). Support the Moondance Programme Board and 29/04/16 Executive PA Moondance Clinical Lead in developing and maintaining the £103,400 application processes. Fund key posts (medical physicist/computer scientist; clinical fellow; and part consultant time) to develop an educational framework 29/04/16 Extension of RTTQA £281,000 around RTTQA to enhance established training and CPD, improving patient care locally, and with the potential to be expanded nationally. Fund a clinical session of consultant oncologist and 6 months of physics/radiographer training Optimisation of access to to improve access to stereotactic ablative 29/04/16 Stereotactic Radiotherapy SW £32,700 radiotherapy (SABR) for medically inoperable Wales early stage lung cancer in patients living in South West Wales. Consultant sessions with protected research time; supervision of a MD student; and develop Consultant Sessions for a prospective clinical study in collaboration with 29/04/16 Radiotherapy Research in £11,300 medical physics and the Cardiff University Brain Neuro-oncology Research Imaging Centre (CUBRIC) within the next 12 months. Fund keys posts to support and implement the interventional clinical study: PET-based VCC-CRW PET Research 29/04/16 Adaptive Radiotherapy Clinical Trial (PEARL), £448,400 Grant some aspects of which have been funded by CRW. Fund a Stereotactic Radiotherapy Development Physicist to support the development and Stereotactic Radiotherapy 29/04/16 implementation of new techniques in intra- £190,000 Development Physicist cranial stereotactic radiosurgery and extra- cranial stereotactic ablative radiotherapy. Equipment, used for H&N immobilisation, which is MRI compatible. This will meet new Q-fix MRI compatible 07/07/16 guidance; open up treatment for a particular £6,900 immobilisation system cohort of H&N patients; and greater access to trials. Oversee the R&D investments made by the Moondance Radiotherapy Programme Board to ensure they deliver their 07/07/16 £63,000 R&D Clinical Lead full potential in terms of investment for Velindre and radiotherapy services in South Wales. Programme management support for funded Moondance Programme 07/07/16 projects; oversight of the programme of work; £165,000 Manager and support for the board.
TOTAL COMMITTED £1,477,600
Page 18
CHARITABLE FUNDS COMMITTEE
FUNDRAISING UPDATE REPORT
Meeting Date: 8th November 2016
Author: Andrew Morris Head of Fundraising, VCC
Sponsoring Executive Director: Andrea Hague, Director Velindre Cancer Centre
Report Presented by: Andrew Morris Head of Fundraising, VCC
Committee/Group who have received or CFC OMG considered this paper:
Trust Resolution to: (please tick) Approve: Endorse: Discuss: Note: Recommendation: The Charitable Funds Committee are asked to NOTE the contents of this report.
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick)
Equitable and timely services
Providing evidence based care and research which is clinically effective Supporting our staff to excel
Safe and reliable services First class patient /donor experience Spending every pound well
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards • Governance, Leadership and Accountability • Staff and resources • Individual Care • Effective Care • Dignified Care
2 Fundraising Update Report
1. Introduction / Background
1.1. This Fundraising report represents exceptional activity and key projects affecting Velindre Fundraising from July - September 2016.
2. Timing/Description:
2.1 This report is provided at every meeting and incorporates the activity that has taken place since the previous Committee.
3. Financial Impact:
3.1 The Income in respect of Fundraising Activity is captured in the tables below and in Appendices A-C of this report.
Monthly income for 2015 2016 Date Actual Legacies Total April 153,712 30,742 184,446.62 May 147,924 87 148,069.94 June 273,367 20,000 295,820.97 July 265,012 0 263,165.28 August 172,144 61,506 223,576.80 September 240,367.00 0 243,697.06 October 220,602 1,000 221,601.69 November 178,024.00 5,000 183,211.93 December 220,388 20,000 240,387.84 January 122,464 357,209.00 479,473.55 February 108,746 15,000 123,743.73 March 226,208 97,581 319,039.38 2,328,958 608,125 2,926,235
1,500,000 M \D £1.5m 4,426,235
Monthly income for 2016 2017 Date Actual Legacies Total April 144,564 5,000 149,564.20 May 178,317 250 178,567.82 June 174,244 250 174,494.54 July 287,060 78,793 365,853.00 August 154,073 £18,051.70 172,124.94 September 164,815.00 164,815.00 1,103,073 102,345 1,205,418
Page 2
3 Fundraising Update Report
4. Quality, Equality, Safety and Patient Experience Impact:
4.1. The vision of the charity supports the Trust’s provision of world class research-led treatment care and support for patients, families and carers affected by cancer and those who are involved in the donation of blood products. Any fundraising activity is considered in this context and that of the charity objectives outlined below.
• General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas.
• Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services.
• Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.”
• Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services.
4.2. By the very nature of how charitable funds are used it supports improving quality and patient/donor experience.
5. Considerations for Board / Committee:
5.1 Fundraising & Sponsorship Success:
• Adopted by S3 advertising agency as their Charity of the Year for the next 2 years.
• New Patron: Shane Williams, new Ambassadors, Huw Williams Jones, Julian Lewis Jones, Derek Brockway, Gareth Way, Sean Holley. Annual Ambassadors evening to take place at the Bear Hotel Cowbridge, Wednesday 2 November, 7.00PM start.
5.2 A selection of some of the fundraising activities that took place during July - September 2016 Please see Appendix One
• The Ride with the Pride New Zealand Bike Ride in June 2017 was officially launched at the Park Plaza Cardiff on 27 April with a Q and A with the 3 bike leaders, British & Irish Lions Shane Williams and Mike Hall, 29 riders recruited.
• The Peru Trek will now take place in September 2017. Early indications for previous Patagonia participants indicate that over 30 will sign up
Page 3
4 Fundraising Update Report
• Ride the Rockies 2016 44 riders completed the first Ride the Rockies bike ride, and 20 riders completed the 2nd Ride the Rockies event.
Page 4
5 Fundraising Update Report
Press coverage: http://www.walesonline.co.uk/news/health/33-hills-2-000ft-south- 11944225#ICID=sharebar_facebook
http://www.barryanddistrictnews.co.uk/news/14764767.Walking_weatherman_Derek_Brockway_le ads_Barry_trek_ahead_of_Peru_charity_challenge/?ref=rss
http://www.walesonline.co.uk/news/health/33-hills-2-000ft-south- 11944225#ICID=sharebar_facebook
5.3 Social Media Velindre Fundraisings Facebook and Twitter numbers continue to grow, with increases from 6158 to 6403 and 6,626 to 6897 respectively
Report: Cancer charities are the nation’s favourite cause to support Fundraising | 7 Oct 2016
Cancer charities are the nation’s favourite cause to support, but children’s charities have fallen beneath animal charities in popularity, according to a report published today.
Facts and Figures: Favourite Causes, a free report published today by consultancy nfpSynergy, found that hospices and other health causes rounded out the top five favourite causes, as they have done since 2010. It found that armed forces charities continued to grow in popularity, and were now at sixth place in the list. As with last year, the report found that the public do not always give the most money to the causes they say are their favourites. 1.1 Other findings "As highlighted in last year’s Facts and Figures report, the public do not necessarily donate the largest amount of money to their favourite causes. Despite cancer being the most popular cause by far, it does not attract the largest proportion of public donations; the cause that attracts the most individual donations is children and young people (30 per cent), ahead of medical research this year (29 per cent) for the first time." "Our 2016 data reveals that most causes are fairly equal in popularity amongst males and females, with 2 notable exceptions. Both male and females picked the same top three causes (cancer, animals and children and young people); however, the data reveals that men are slightly more likely to favour armed forces causes. 21 per cent of men picked armed forces causes, as opposed to only 17 per cent of women. In addition, women continue to be far more likely to favour animal charities than men (40 per cent and 28 per cent respectively)." "Looking at ten year trends, homelessness and social welfare have increased in popularity, rising from 12 per cent in 2007, to 16 per cent in 2016. This increase in popularity correlates with a rise in homelessness since 2010 and a surge in media coverage of food waste and hungeriv, both of which could have led to greater awareness of social welfare issues. The high level of austerity following the 2008 financial crisis and a subsequent reduction in social welfare provision under the current Conservative Government has meant that homelessness and social welfare have become pressing issues in the UK." 1.2 Methodology In July, nfpSynergy asked 1,000 charity supporters to name as many of their favourite causes as they wanted, and also to give information on which charities they donated to and volunteered for.
6. Next Steps:
Page 5
6 Fundraising Update Report
6.1. The Charitable Funds Committee is asked to NOTE the contents of this report.
Appendix A contains reports showing donations received by ‘event’ code and also by ‘fund’ code for the month of July 2016.
Donations received by EVENTDiamond July 2016Ball 16 Bost2NY14 CAF16 Cardiff Triathlon 16 Celeb Football 16 Cardiff Half Marathon 16 COTY16 IMO16 JDGD16 Legacy16 London Marathon 16 Mairs Walk 16 Martyn Williams Walk 16 Merchandise Misc16 Patagonia Patagonia Rhod Patagonia Shane Peru17 Pride17 Reg16 Reindeer15 RhianRose16 Rockies16 Rockies216 Run16 Sky16
Event Code Total Diamond Ball 16 £2,964.00 Bost2NY14 £7.13 CAF16 £1,589.39 Cardiff Triathlon 16 £1,172.49 Celeb Football 16 £0.00 Cardiff Half Marathon 16 £822.44 COTY16 £5,147.16 IMO16 £24,190.21 JDGD16 £1,200.00 Legacy16 £78,793.48 London Marathon 16 £94.55 Mairs Walk 16 £6,905.10 Martyn Williams Walk 16 £1,896.96 Merchandise £104.00 Misc16 £22,894.78 Patagonia £50.00 Patagonia Rhod £233.95 Patagonia Shane £30.88 Peru17 £1,809.91 Pride17 £4,568.87 Reg16 £1,624.00 Reindeer15 £33.26 RhianRose16 £2,771.22 Rockies16 £63,565.69 Rockies216 £12,352.01 Run16 £60.00 Sky16 £77.88 SuppEvents16 £121,837.71 TeamEvsy £6,979.91 Tin16 £368.11
Page 6
7 Fundraising Update Report
Wedding16 £757.00 World16 £151.81 £365,053.90 Donations received by FUND July 2016
6000 Hospital General Purposes Fund 6100 Patients General Purposes Fund 6103 Ward - Patients
6104 Equipments
6300 Research General Purposes Fund 6303 Breast Research (In The Pink Appeal) 6304 Urology / Prostate
6305 Lung Cancer (Stepping Stones Appeal) 6306 Undercover Appeal
6307 Research Gynaecological (Aphrodite Appeal) 6308 Advanced Radiotherapy / R&D Cutting Edge 6309 ATTAC Appeal
6310 Head and Neck / Thyroid
6312 Brain
Fund Total
6000 Hospital General Purposes Fund £181,058.30 6100 Patients General Purposes Fund £5.00 6103 Ward - Patients £408.00 6200 Staff General Purposes Fund £7,550.00 6300 Research General Purposes Fund £495.00 6303 Breast Research (In The Pink Appeal) £79,475.48 6304 Urology / Prostate £2,168.12 6305 Breast Research (In The Pink Appeal) £5.00 6305 Lung Cancer (Stepping Stones Appeal) £9,436.98 6306 Undercover Appeal £808.75 6307 Research Gynaecological (Aphrodite Appeal) £4,138.72 6308 Advanced Radiotherapy / R&D Cutting Edge £66,916.96 6309 ATTAC Appeal £2,952.50 6309 Research General Purposes Fund £10.00 6310 Head and Neck / Thyroid £641.18 6311 Lymphoma £200.00 6312 Brain £7,404.91 6317 Radiotherapy Department £30.00 6321 Macmillan Cancer £1,000.00 6500 WBS General Purposes Fund £24.00 6610 NPHS- BTW General Purposes Fund £300.00
Page 7
8 Fundraising Update Report
£365,028.90
Appendix B contains reports showing donations received by ‘event’ code and also by ‘fund’ code for the month of August 2016. Donations received by EVENT August 2016 Diamond Ball CAF16 Cardiff Triathlon 16 Cardiff Half Marathon 16 COTY16 IMO16 Legacy16 London Marathon 16 Mairs Walk 16 Martyns Walk 16 MegaRun16 Merchandise Misc16 Overseas16 Peru17 Ride with the Pride 17 Regular Givers 16 RhianRose16 Rockies16 Rockies216 Run16 Sky16 SuppEvents16 TeamEvsy Tin16
Event Code Total Diamond Ball £4,010.00 CAF16 £3,092.93 Cardiff Triathlon 16 £420.63 Cardiff Half Marathon 16 £1,588.75 COTY16 £460.37 IMO16 £15,978.85 Legacy16 £53,051.70 London Marathon 16 £1,327.58 Mairs Walk 16 £1,291.58 Martyns Walk 16 £57.58 MegaRun16 £50.00 Merchandise £727.00 Misc16 £10,980.76 Overseas16 £1,253.09 Peru17 £3,947.89 Ride with the Pride 17 £7,686.03 Regular Givers 16 £1,767.00 RhianRose16 £437.45 Rockies16 £10,264.75 Rockies216 £5,690.20 Run16 £366.25 Sky16 £73.75 SuppEvents16 £43,499.85 TeamEvsy £2,851.15
Page 8
9 Fundraising Update Report
Tin16 £969.80 Wedding16 £280.00 £172,124.94
Donations received by FUND August 2016 6000 Hospital General Purposes Fund
6100 Patients General Purposes Fund
6103 Ward - Patients
6104 Equipments
6300 Research General Purposes Fund
6303 Breast Research (In The Pink Appeal)
6304 Urology / Prostate
6305 Lung Cancer (Stepping Stones Appeal)
6306 Undercover Appeal
6307 Research Gynaecological (Aphrodite Appeal)
Fund Total
6000 Hospital General Purposes Fund £152,705.56
6100 Patients General Purposes Fund £5.00 6103 Ward - Patients £835.00 6104 Equipments £1,000.00
6300 Research General Purposes Fund £377.04 6303 Breast Research (In The Pink Appeal) £2,971.48 6304 Urology / Prostate £748.35 6305 Lung Cancer (Stepping Stones Appeal) £1,456.58 6306 Undercover Appeal £408.70 6307 Research Gynaecological (Aphrodite Appeal) £1,051.45 6308 Advanced Radiotherapy / R&D Cutting Edge £132.30 6309 ATTAC Appeal £2,570.09 6310 Head and Neck / Thyroid £175.00 6312 Brain £2,851.15 6321 Macmillan Cancer £4,527.25
6500 WBS General Purposes Fund £110.00 6610 NPHS- BTW General Purposes Fund £200.00
Page 9
10 Fundraising Update Report
£172,124.94
Appendix C. Appendix C contains reports showing donations received by ‘event’ code and also by ‘fund’ code for the month of September 2016
Donations received by EVENT September Diamond Ball 16 2016 bike18 Body Basics Walk 16 CAF16 Cardiff Triathlon 16 Cardiff Hald Marathon 16 COTY16 IMO16 Jonathan Davies Golf Day Legacy16 Mairs Walk 16 Martyns Walk 16 Merchandise Misc16 Overseas16 Peru17 Ride With the Pride 17 Regular Givers RhianRose16 Rockies16 Rockies216 Run16 Sky16
Event Code Total Diamond Ball 16 £2,094.00 bike18 £3,083.26 Body Basics Walk 16 £20.00 CAF16 £204.81 Cardiff Triathlon 16 £25.00 Cardiff Half Marathon 16 £9,914.72 COTY16 £883.40 IMO16 £13,540.48 Jonathan Davies Golf Day £400.00 Legacy16 £85.79 Mairs Walk 16 £8.75 Martyns Walk 16 £10.00 Merchandise £150.00 Misc16 £13,996.24 Overseas16 £200.00 Peru17 £14,042.16 Ride With the Pride 17 £4,277.50 Regular Givers £1,764.00 RhianRose16 £1,804.50 Rockies16 £28,950.11 Rockies216 £5,566.75 Run16 £1,783.50 Sky16 £552.50 SuppEvents16 £55,300.90 TeamEvsy £4,608.72 Tin16 £362.73
Page 10
11 Fundraising Update Report
Wedding16 £140.00 £163,769.82
Donations received by FUND September 6000 Hospital General Purposes 2016 Fund 6100 Patients General Purposes Fund 6203 Radiotherapy Staff Fund
6300 Research General Purposes Fund 6303 Breast Research (In The Pink Appeal) 6304 Urology / Prostate
6305 Lung Cancer (Stepping Stones Appeal) 6306 Undercover Appeal
6307 Research Gynaecological (Aphrodite Appeal) 6308 Advanced Radiotherapy / R&D Cutting Edge 6309 ATTAC Appeal
6310 Head and Neck / Thyroid
Fund Total 6000 Hospital General Purposes Fund £147,388.44 6100 Patients General Purposes Fund £5.00 6203 Radiotherapy Staff Fund £240.00 6300 Research General Purposes Fund £5.00 6303 Breast Research (In The Pink Appeal) £807.79 6304 Urology / Prostate £275.00 6305 Lung Cancer (Stepping Stones Appeal) £78.67 6306 Undercover Appeal £1,550.86 6307 Research Gynaecological (Aphrodite Appeal) £2,464.50 6308 Advanced Radiotherapy / R&D Cutting Edge £3,241.28 6309 ATTAC Appeal £675.00 6312 Brain £6,478.28 6316 Diagnostic X-Ray Fund £60.00 6321 Macmillan Cancer £500.00 £163,769.82
Page 11
Appendix One:
24-25 September 2016: Hannah-Lee Docherty has raised over £10,000 completing the Hever Castle Triathlon.
17&18 September: 5-year-old Nia took part in the IronKids 500m and her Dad Rhodri the full Ironman Wales, in memory of Nia’s best friend, her Grandfather, raising £2337.
July – September: Ryan Owen has been walking (and camping) for 3 months from Lands End to John O’Groats whilst also summiting the UK’s 3 Peaks
25 September: Walk with the Weatherman from Barry to Rhoose
CHARITABLE FUNDS COMMITTEE REPORT
FUNDRAISING REGULATOR
Meeting Date: 8th November 2016 Author: Cally Hamblyn, Legal Services & Governance Manager Andrew Morris, Head of Fundraising Sponsoring Executive Director: Mark Osland, Executive Director of Finance & Information Report Presented by: Andrew Morris, Head of Fundraising
Committee/Group who have received Charitable Funds Operational Management Group th or considered this paper: – 20 October 2016
Trust Resolution to: (please tick) APPROVE: REVIEW: INFORM: ASSURE: Recommendation: The Charitable Funds Committee is asked to CONSIDER and APPROVE the recommendation from the OMG to register with the Fundraising Regulator.
This report supports the following Velindre NHS Trust Charity Objectives (please tick) General – For charitable purposes relating to the general or specific purposes of Velindre NHS Trust or to purposes relating to the health service and for any other Health Services for which specific monies have been donated for use within the UK or overseas. Patients - For the relief of illness of patients suffering from cancer or its effects that are or have been treated by Velindre Cancer Services. Staff - For the relief of sickness by promoting the efficient and effective performance and duties of Velindre Trust staff.” Research - For any charitable purpose or purposes principally (but not exclusively) at or in connection with Velindre Cancer Services. Welsh Blood Service - For any charitable purpose or purposes relating to the National Health Service wholly or mainly for the services of the Blood Transfusion Service in the area served by the Welsh Blood Service.
This report supports the following Trust objectives as set out in the Integrated Medium Term Plan: (please tick) Equitable and timely services Providing evidence based care and research which is clinically effective Supporting our staff to excel Safe and reliable services First class patient /donor experience Spending every pound well ACRONYMS
OMG – Charitable Funds Operational Management Group 2 Fundraising Regulator
This report supports the following Health & Care Standards: http://www.wales.nhs.uk/governance-emanual/health-and-care-standards
• Governance, Leadership and Accountability • Staff and resources • Individual Care • Effective Care • Dignified Care
Page 2
3 Fundraising Regulator
1. Introduction / Background
1.1 One of the key changes in the Charities (Protection and Social Investment) Act 2016 was the launch of the Fundraising Regulator on the 7th July 2016.
1.2 The Fundraising Regulator is the independent regulator of charitable fundraising and was established following the Etherington review of fundraising self-regulation (2015) to strengthen the system of charity regulation and restore public trust in fundraising.
2. Timing:
2.1 The Fundraising Regulator launched on the 7th July 2016.
2.2 On the 6th October 2016 the Trust was contacted to make arrangements to pay the levy to support the Fundraising Regulator (see financial impact – section 4).
3. Description:
3.1 The role of the regulator is to:
• Set and promote the standards for fundraising practice (‘the code’ and associated rulebooks) in consultation with the public, fundraising stakeholders and legislators. • Investigate cases where fundraising practices have led to significant public concern. • Adjudicate complaints from the public about fundraising practice, where these cannot be resolved by the charities themselves. • Operate a fundraising preference service to enable individuals to manage their contact with charities. • Where poor fundraising practice is judged to have taken place, recommend best practice guidance and take proportionate remedial action.
3.2 Further information on the Fundraising Regulator is available on their website via the following link: https://www.fundraisingregulator.org.uk/
4. Financial Impact:
4.1 The ‘Fundraising Regulator’. Rather than a membership body like the FRSB we will regulate the whole charity sector. The review declared that for the regulator to be independent and not statutory, it needed to be funded by charities themselves.
4.2 The recommendation was that this be in the form of a Levy on fundraising expenditure so charities that spend over 100K on fundraising are to contribute to the running costs of the Regulator. As the Velindre NHS Trust Charity has submitted accounts to the Charity Commission that declare Fundraising expenditure of over £100,000 the Charity will be asked to contribute.
4.3 Based on the information received to date it is anticipated that Velindre NHS Trust Charity would pay the following fees:
Levy: £800
4.4 It appears that whilst the payment of this levy is voluntary, the government’s charity bill does give it the power to impose a mandatory registration fee if charities refuse to comply.
Page 3
4 Fundraising Regulator
5. Quality, Equality, Safety and Patient Experience Impact:
5.1. The aim of the regulator is to ensure that the Velindre NHS Trust Charity adheres to good fundraising practices to provide positive and safe fundraising experiences to the public.
5.2. It provides an adjudication role in respect of complaints where these cannot be resolved by the charities themselves.
6. Considerations for Board / Committee:
6.1 Code of Fundraising Practice
The Code of Fundraising Practice and its associated rule books for street and door fundraising outline the standards expected of all charitable fundraising organisations across the UK. The standards were developed by the fundraising community through the work of the Institute of Fundraising (IoF) and Public Fundraising Association (PFRA).
In 2015, a Review of Fundraising Regulation chaired by Sir Stuart Etherington identified a need for responsibility for the Code and the rule books to be transferred to a new Fundraising Regulator to safeguard the independence of fundraising regulation.
The Code and the rule books have been formally transferred to the Fundraising Regulator at its launch on 7th July 2016. Decisions on changes to the Code will be made by the Fundraising Regulator’s Standards Committee in consultation with fundraising stakeholders.
The Code of Fundraising Practice can be found on the following link: https://www.fundraisingregulator.org.uk/code-of-fundraising-practice/code-of-fundraising- practice
6.2 Impact in respect of Velindre NHS Trust Charity Fundraising
As existing members of the Fundraising Standards Board, the new Regulator will give additional confidence to the general public, especially as registered charities will sign up to the Fundraising Promise and Fundraising Code of Practice.
Institute of Fundraising Chief Executive Peter Lewis said: “We believe that the fundraising community will be better served by this new, stronger Fundraising Regulator, able to act more quickly and effectively if poor fundraising practice is exposed. Its existence gives members of the public an effective place to go, and with a new independent remit to set standards it will no doubt help us all rebuild trust in charity fundraising practice. We look forward to working closely with the new regulator.”
6.3 Registering with the Fundraising Regulator
Charities and other fundraising organisations will be invited to register with the Fundraising Regulator from autumn 2016, to signal their commitment to good practice.
It is understood that this registration will soon replace the Fundraising Standards Board (FRSB) symbol currently used on fundraising material and those who register will be eligible to use a badge on marketing materials which states they are registered with the new regulator. The new badge will not be made available before this as registration will be a condition of being able to use it
Page 4
5 Fundraising Regulator
6.4 Recommendation from the Operational Management Group.
The OMG recommends to the Committee that the Velindre NHS Trust Charity registers with the Fundraising Regulator to ensure continued confidence to the general public in respect of its fundraising activities.
7. Next Steps:
7.1 The Charitable Funds Committee is asked to CONSIDER and APPROVE the recommendation from the OMG to register with the Fundraising Regulator.
Page 5
VELINDRE NHS TRUST
CHARITABLE FUNDS COMMITTEE REPORT
Meeting Date: 8th November 2016
Agenda Item: 7.3
Report Author: Andrew Morris Head of Fundraising
Executive Sponsor: Andrea Hague, Director VCC
Presented by: Andrew Morris Head of Fundraising
STAFF TAKING PART IN OVERSEAS FUNDRAISING TRIPS
ACRONYMS
1. PURPOSE & ACTION REQUIRED
Charitable Funds Committee is asked to approve a maximum of 5 members of staff to attend overseas trips whilst raising a minimum of 50% of sponsorship level.
2. INTRODUCTION
Background. Over the last 6 years Velindre Fundraising Department have organised a number of highly successful treks and bike ride events:
2010 - Kilimanjaro trek 1 and 2 2011 - Kilimanjaro 3, Peru trek 2012 - California Bike Ride 1 and 2 2013 - Kilimanjaro trek 4 2014 – East Coast Bike Ride 1 and 2 2015 – Ride the Rockies 1 and 2
These activities serve a number of purposes: • They raise funds • They create beneficial publicity • Offer an opportunity to recruit future fundraisers for Velindre
Overseas events provide a unique opportunity to spend valuable time with supporters, and to be able to develop and build relationships.
Spending time with some of Wales’ leading business people offers a rare chance to be able to explain in detail the work, vision and needs of Velindre Cancer Centre. Having members of staff who can speak of their first hand experiences at Velindre is a great asset.
Members of staff impact on a trip has resulted in first time participants becoming regular supporters of Velindre. This has resulted in a number of substantial donations being made following trips.
Members of staff add considerable value to the trips, allowing participants to have firsthand experience of working at Velindre.
A number of members of staff have previously supported overseas trips, but combining their daily role whilst trying to raise several thousand pounds is challenging.
Given the impact that the presence of staff can have on a trip, it is proposed to support their involvement by the following:-
• Reducing the sponsorship ask by 50%. This will ensure that the costs of the trip are always covered, and that participants will benefit from the additional insight key members of staff can bring. • It is proposed that this would apply to a maximum of 5 members of staff per trip. • Members of staff taking part in trips would be required to contribute before trips, by attending cheque presentations and speaking at fundraising functions, raising the equivalent of the outstanding sponsorship in funds donated at these cheque presentations. • Providing kit for staff to take part in overseas challenges
3. CONSIDERATIONS FOR BOARD/COMMITTEE
4. ACTIONS/RECOMMENDATION TO THE BOARD/COMMITTEE
Charitable Committee are asked to approve the agreed options above which have previously been approved by OMG.