Changing Cancer Care (CCC) General Assembly 5
Video Conference, Mai 6th 2021 Agenda
2 During this meeting
Please turn of your microphone! (and remember to turn it on again when speaking) Here is the chat!
If you have a question or comment, please write in the chat in the left column on your screen. Type here
3 Presentation of participants I
Please open your microphone, when presented (and then turn it off again)! • 10 Universitätsklinikum Schleswig-Holstein, Campus Kiel, Institut für Klinische Molekularbiologie (IKMB) • 09 Universität zu Lübeck, Sektion für Forschung und Lehre in der Pflege am Institut für Sozialmedizin und Epidemiologie • 08 Institut für Krebsepidemiologie e.V., Universität zu Lübeck, Krebsregister Schleswig-Holstein (IKE) • 07 Universität Lübeck, Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie) • 06 Universität zu Lübeck, Klinik für Strahlentherapie
4 Presentation of participants II
• 05 Kræftens Bekæmpelse (KB)
• 04 Sygehus Lillebælt, Vejle Sygehus, Onkologisk Afdeling
• 02 University College Absalon (UCA) • 01 Sjællands Universitetshospital, Forskningsprojekter og Klinisk Optimering • LP Sjællands Universitetshospital (SUH)
5 Presentation of participants III
Network partners and guest: • Dr. Maria Karsten, Gynecological Clinic at Charité Hospital in Berlin • Dr. Lennart Friis-Hansen, Clinical Biochemical Department at Bispebjerg Hospital in Copenhagen • Dr. Annika Rademacher and Dr. Fabian Frietlitz, research project KULT-SH at the Pediatric Clinic at UKSH in Kiel and Lübeck • Dr. Mikkel Dorff, head of Hematological Department at SUH in Roskilde • Dr. Mads Nordahl Svendsen, head of Oncological Department at SUH in Roskilde/Næstved
6 WP1: Project Management
Niels Henrik Holländer, Julie Gehl and Keld Hundewadt General Assembly, May 6th 2021
7 Covid-19 in Germany and Denmark, the current situation
New infections in the last 7 days (per 100.000 inhabitants)
8 Covid-19, travelling from Denmark to Germany.
When can we meet again?
9 Covid-19 in Germany and Denmark, the development
Differences in national strategies and the development of the Covid19 pandemic
Development in Deaths (per 1 mio. inhabitants)
nfections
I
Vaccinations Tests
10 The golden triangle in laboratory testing (WP4) Frequency and turn around time is more important than test quality!
Test Quality/sensitivity
Biggest impact on patient outcome
Test frequency Test Turnaround time Understand the disease, the test and the intervention
11 The golden triangle of Medicine Patient ressources and access to treatment is crucial!
Health care staff education and training
Biggest impact on patient outcome
Patient ressources and wishes Treatment; access and quality Understand the disease, the patient and the treatment
12 What´s new
New activities and changes: • WP1, WP5 and WP6 did already prolong the project period until June 2022. Now WP3 has decided for a prolonging too! • A prolonging of WP2 and WP4 is pending. • The project partner from Odense Universitetshospital (OUH) has left Changing Cancer Care from the the beginning of this year. Vejle Hospital has agreed to take over the Danish contribution to the Spinal cord compression radiotherapy in WP5.3. • The Pediatric Clinic at UKSH in Kiel and Hematological Department at SUH in Roskilde has started the Interreg network project HomeHemo. The aim is to enable child and adult hematological patients to do blood tests in their own home.
13 Project reporting and accounting
Annual report 2020 and upcoming application change request • The annual report and accounting for 2020 was submitted in mid February. • The Interreg Secretariat has approved the annual report. • We are stille wating for the approval of the managing authority (Verwaltungsbehörde) in Kiel. This is expected at the end of May. • As soon as the Annual report 2020 has been approved, we will start to work on the application change request and adjusted budgets for 2021 and 2022.
14 Administrative reminders I
Interreg: • All additional expenses to the budget must be approved by Interreg in ELMOS – also when covered within the budget. • It is no longer possible to make 1:1-shifts in the budget to next year´s budget without Interreg´s approval! • Please inform WP1 and Interreg about participations in public events. Interreg wish to share this in their “Event Calendar”. • Please share ongoing results of the single WPs, so that our homepage and the Interreg CCC project blog can be updated. • Reference to EU funding – it´s obligatory to use the logo and reference to EU Interreg funding on all materials prepared in and payed for by CCC: Dette projekt finansieres af midler fra Den Europæiske Fond for Regionaludvikling Dieses Projekt wird gefördert mit Mitteln des Europäischen Fonds für regionale Entwicklung
15 Administrative reminders II
Use the CCC online platform at Cancerdk365:
• For sharing documents, minutes, photos, results etc. • Here you can also find the updated contact list for all partners. • Link: https://cancerdk365.sharepoint.com/sites/CCC/ • If you need help or don´t have access, please contact Keld.
16 Administrative reminders III
Be aware of national and EU requirements for documentation: • Get 3 prices before purchasing equpiment or services (keep the documentation, such as written offers, screenshots etc.). • Be aware of national depreciation rules when purchasing equipment. • Be aware of national and EU tender procedures. • Attach signature lists, meeting minutes ect. to your meeting or/and travel expenses. • Keep all documents for • It is always a good idea to have a look into the Interreg hand book: • https://www.interreg5a.eu/dokumente/interreg-handbuch/ • https://www.interreg5a.eu/dk/interreg-handbog/
17 WP2: Communication
Dirk Keil and Elise Burmeister General Assembly, May 6th 2021
18 Goal and Activities
To communicate the project to citizens, decision makers and health professionals in the program region.
Activity 2.1 Startup activities incl. communication Press release, logo, templates, fact sheet, kick-off event, website, communication strategy. strategy and website
Activity 2.2 Publications Min. 20 articles in the press, research publications (WP3-6), information for citizens and patients, newsletter
Activity 2.3 Events 2 co-creation events, 9 presentations on conferences or external meetings, 1 midterm and 1 final conference
Activity 2.4 Printed materials 2 brochures, 2 flyers, roll-up /poster and merchandise etc.
Activity 2.5 Digital activities such as social media 1 Facebook page and 2-4 small films and multimedia
19 Status on activities
• Press • Focus on German press
20 Status on activities
• Focus on German press
21 Status on activities
• Newsletter – internal, 6 in total • Events – 7 so far
22 Status on activities
• Facebook – one post every week • Website – is continously updated
23 What to expect the coming half year
24 WP3: Innovations in nursing care
General Assembly (online), 6th May 2021
25 Work Package Team
• Lead: Christina Louise Lindhardt, University College Absalon • Members: – Katrin Balzer, University of Lübeck – Gundula Bergtrøm, Absalon – Pernille Brandt Schmidt, Absalon – Anna Jacobsen, Absalon – Frederike Lüth, University of Lübeck – Kitt Vestergaard – Mette West Gajhede Eskesen, Absalon
26 Scoping Reviews
1. Supportive technologies in cancer nursing (submitted to Cancer Nursing Journal) • Under revision (search update) 2. Development of tasks and roles in nursing and interprofessional oncological care • Overview of Reviews • Submission (English language) to “Pflege” (Medline- registered German nursing science journal)
27 Curriculum on innovations in oncological nursing care
• Target groups: Nurses working in oncological care • Main subjects: New treatments and technologies in cancer care, person-centred care, implementation of innovations, special patient group, communication, empowerment and shared decision-making • Curriculum 1: Absalon – Main characteristics: 10 ECTS, 40 lectures, 1 assignment – Implemented in Sept. 2020, evaluation completed • Curriculum 2: Lübeck – Main characteristics: 2 ECTS, 40 lectures (blended learning, incl. 1 round table talk between Danish and German nurses), 1 assignment – Informed by qualitative study (in progress) – Implementation in Sept.-Oct. 2021 (collaboration with University Hospital Schleswig- Holstein), incl. formative and summative evaluation
28 Interim lessons learned
• Cross-country differences in professional roles, tasks and career pathways in nursing profession Impact on quality of care? • Country-specific adaptions of curriculums for continuing education required • Cross-country exchange of expertise and experiences in nursing profession not usual
29 Dissemination
1. Publications – 1 article in review and 2 in writing progress
2. Public communication (collaboration with Work Package 2) • Report about curriculum for continuing nursing education in oncological care in Lübeck
30 Ongoing project activities in Denmark
Curriculum 2 – desk research • Target group: Public Health Nurses working in the municipality • Main subjects: New innovations and technology • Status: Individual and focus group with Public Health Nurses
• Data generation in progress and the prototype curriculum will be finished June 2021
31 Ongoing project activities in Denmark
Qualitative research • Target group: Patients who are being treated with calcium- electroporation at the University Hospital Næstved • Main subjects: The experience of being treated with calcium electroporation and quality of life – interviews at baseline – 2 months and 12 months • Status: Seven patients included in total
32 Ongoing project activities
• Development of assessment tool ‘Socrative’ for curriculum development
• An online assessment tool has been tested on the participants on the test course in autumn 2020
• A short film for demonstration and an e-book has been developed as part of the toolbox for the WP 3
33 WP4: Blood test in patients home
General Assembly 5, May 6th 2021 Aim of study
• To test usability of HemoScreen by patients
• Compare capillary blood counts in patients, measured using HemoScreen versus laboratory measurement of venous blood counts
• Investigate how the patient experience the use of HemoScreen for self-testing at home Timeline – the different test phases
Phase 2: Phase 3: Self-testing in patients home Phase 1: Usability N = 33 patients Verification testing at of devices hospital in lab 10 patients
01.01.2020 01.07.2020 01.01.2021 01.07.2021 01.01.2022 Study, phase 3: Testing in patients home
• Department of Clinical Oncology ZUH, Næstved, outpatient clinic • Measurements and data collected:
Phase 3 33 patients receiving Capillary self-test (by Observed self- Interview right chemotherapy nurse and self-test) test after self-test Patients at hospital at at hospital at hospital self-testing at inclusion. home Approximately 6 venous test at hospital and 6 self- test at home prior to chemo therapy (HOTline available) 5-7 of the 33 patients One additional Observed self- Interview at enrolled for home- capillary self-test at test at home home testing home Status of phase 3: Testing in patients home
• The first patient was recruited in December • So fare 11 patients have been included, 35 capillary blood tests conducted in home • Five HemoScreens will return in May • 8 contacts to Hotline • Qualitative interviews planned Qualitative interviews
• Observation and interview in patients home: • How did it work? • My SP • Challenges and how they were solved – Hotline, video? • Registration of side effect • Co-creation element TV2 East featured our study Thank you WP5: Innovative cancer diagnosis and treatment methods WP5.1: Liquid Biopsy - Malene Støchkel Frank WP5.2: Calcium Electroporation – Julie Gehl WP5.3: Spinal cord compression radiotherapy - Dirk Rades
General Assembly, May 6th 2021 WP5.1 Lung cancer liquid biopsy
Zealand University Hospital, Næstved, 28.04.2021 Malene Støchkel Frank and Niels Pallisgaard (DK), Michael Forster (DE)
43 Aims
• to assess how the levels of circulating tumor DNA, measured in plasma, during treatment correlate to treatment response in patients with advanced non-small cell lung cancer
• to identify resistance mechanisms and molecular therapeutically actionable targets through plasma analyses
44 Inclusion rate
2018 2019 2020
Included 160 Expected
140 s
t 120
n e
i 100
t a
p 80 Included - total: 158
f o
60
. o
N 40 20 0 p c r n p c r n p c e e a u e e a u e e -S -D -M -J -S -D -M -J -S -D l t n r l t n r l t u c a p u c a p u c J O J A J O J A J O
45 Publications
46 47 48 Project plans
• Publication under review in BioTechniques Published
• Liquid biopsy study: selecting patients for substudy analyses in Kiel – in process Completed
• Preparation of plasma samples: Isolation of cell free DNA
• Transferral of samples for analyses at IKMB, Kiel (end-May)
49 Conclusion and future
• Project delay due to COVID-19 pandemic (transferral of samples)
• Analyses performed, interpretation of results and writing process in progress in 2021
• Grant application in process (DFG)
• Liquid Biopsy Symposium presentation – 27th of October 2021
50 WP 5.2 Calcium Electroporation
51 Calcium electroporation protocol
Protocol • 30 patients (10 at each centre: Vejle, Næstved, Lübeck). • All cancer diagnoses with cutaneous metastases • Endpoint (primary): Response at 2 months • Total follow-up 12 months
52 Progress
• Protocol approved, Næstved and Vejle. Lübeck awaits approval.
• Registered on Clinicaltrials.gov
• Lübeck to start pending protocol approval (awaits ammendment).
• Coronavirus epidemic has led to delays due to travel restrictions and changes in workflow at hospitals.
53 Patient inclusion
54 Pictures from treatment of pt. No 5
Injection of local anesthetic
Injection of calcium
Application of electric pulses
55 MR at Vejle
As part of the protocol in Vejle, MR imaging will be made to visualize the effects of the Calcium Electroporation treatment on the cancer tumors.
56 Publications
Protocol paper • In final review (with Editor) at BMJ Open (British Medical Journal portfolio).
Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin Mille Vissing (1,2), John Pløen (3), Mascha Pervan (4), Kitt Vestergaard (5), Mazen Schnefeldt (6), Stine K Frandsen (1), Søren Rafael Rafaelsen (6), Christina Louise Lindhart (5,7), Lars Henrik Jensen (3), Achim Rody (4), Julie Gehl* (1,2)
57 Plans for the coming 6 months
• Protocol paper in submission to BMJ open • Næstved cohort possibly completing accrual of total ten patients within the next 6 months • Vejle to continue patient accrual • Lübeck awaiting final approval and will then commence inclusion • Coronavirus pandemic continues to affect work flows in hospitals as well as restrict travel (clinical training, meetings).
58 4th World Congress on electroporation
POSTPONED October 9th to 13th, 2022 Expected presentations on calcium electroporation and the new curriculum
Abstract deadline: April 2022.
59 WP 5.3 Spinal cord compression radiotherapy
60 RAdiotherapy for Metastatic Spinal cord compression with increased radiation dosES (RAMSES-01)
Prasad et al. Lancet Oncol 2005
100
80
60 % 40
20
0 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
Rades et al., Cancer 2008
61 RAdiotherapy for Metastatic Spinal cord compression with increased radiation dosES (RAMSES-01)
• Study leader: Dirk Rades, Radiation Oncology, University of Lübeck
• ≥35 points (retrospective study): Increased Dose => Better Local PFS
• Phase II Study: High-precision RT with 18 x 2.333 Gy or 15 x 2.633 (fewer RT-Sessions in times of COVID-19) versus Historical Control Group: 10 x 3.0 Gy of conventional RT
• => Increase of Equivalent Dose by 33% or 28%.
62 RAdiotherapy for Metastatic Spinal cord compression with increased radiation dosES (RAMSES-01)
• Primary goal (Phase II) = 12-month LPFS and to demonstrate that the rate is superior to conventional RT with 10x3 Gy; required patients N=65
• Centers that contributed patients: • University of Lübeck, Germany N=15 • Cruces University Hospital/BHRI, Barakaldo, Spain N=6 • Tbilisi State Medical University, Georgia N=6 • University of Ljubljana, Slovenia N=2 • Acad. F. Todua Medical Center Tbilisi, Georgia N=2 • Catalan Institute of Oncology, Barcelona, Spain N=1 • University Hospital Ramón y Cajal, Madrid, Spain N=1
63 RAMSES-01: Current status
• 03/2019: EC Approval for initial protocol • 11/2019: Original study protocol published in BMC Cancer • 04/2020: EC Approval for amended protocol (15x2.633 Gy) • Recruitment status: 33 of 65 patients • Current LPFS = 96.6% (4 patients with FU of 12 mos., no progression) • Additional study (Radiat Oncol, 1/2021): Comparison of 5x5 Gy and 10x3 Gy for metastatic spinal cord compression using data from three prospective trials
64 RAMSES-01: Current status
• Recruitment should have been completed 04/2020; only 50% achieved. • Recruitment: Extension till 04/2021. • Trial will likely be closed prematurely (due to slow accrual). • Early June: Discussion with corresponding centers:
1. No patients until 30-08-2021 => Closure of the center ? 2. <2 patients until 30-11-2021 => Closure of the center ? (3. Only inclusion of ≥3 patients will qualify for co-authorship.)
65 WP6: Quality of cancer treatment and patient involvement in research and care
General Assembly 5, May 6th, 2021
66 WP aim
To assess and improve the quality of cancer care and treatment using two approaches:
• Patient involvement in care evaluation • Cancer surveillance based on registry data Institutions
• Common experiences from previous projects • Population-based, data-driven approaches WP activities at a glance
• 6.1: Improvement of PREM/PROM-questionnaire capturing patients’ own evaluation of treatment and care
• 6.2: Assess patients’ perspective on treatment and care delivery in large-scale survey • 6.3: Linking research activities from WP4-5 to the patients’ perspective • 6.4: Cancer surveillance and disease mapping Status report
6.1: Improvement of PREM/PROM-tool
Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are used to evaluate health care quality from the patients' perspective. Our aim is to develop a tool, which is valid on both sides of the border and allows cross-border benchmarking.
• Long version for use in WP6.2 was under revision • Adaptation to German GP/ out-patient care system • Adaptation to Covid-19-related lockdown and changes in care • Now being designed in TeleForm (machine-readable data form) Status report cont`d
6.2: Assess patients‘ perspective on treatment and care delivery in large-scale survey
A population-based survey among cancer patients in Schleswig-Holstein will be conducted using the innovative tool for involving patients in the evaluation of cancer treatment quality, which is being developed in Activity 6.1.
• Received addresses and clinical-epidemiological data for 1 044 patients diagnosed from August 2020 to January 2021 • Amendment vote necessary due to changes in questionnaire, delay of survey and changes in study design is pending Status report cont`d
6.2 cont‘d: Assess patients‘ perspective on treatment and care delivery in large-scale survey
• Survey among cancer patients newly diagnosed August 2020 to January 2021 • 1 044 eligible patients in Schleswig-Holstein Cancer Registry • All cancer sites but C44, C76, C80 • Consent to be contacted for research purposes • One wave of data collection June to July `21 with one reminder Status report cont`d
6.2 cont‘d: Assess patients‘ perspective on treatment and care delivery in large-scale survey
• Evaluation of teleconsultation in oncology during the Covid-19 pandemic in Denmark • Patient survey is completed and manuscript is under review • Qualitative interviews with health care staff, patients and relatives are conducted; analysing and writing stage • Health record audit of lung cancer treatment comparing care prior to the pandemic to care during Covid-19 Status report cont`d
6.3: Linking research activities from WP4-5 to the patients‘ perspective
The aim is to assess patient experiences (PREMs) and subjective health outcomes (PROMs) also in cancer patients who participate in the trials in WP 4 and WP 5 in order to evaluate the patients' perspective on innovative diagnostic and treatment solutions that differ from standard care.
• Amendment of RAMSES-01 study protocol for PREM/PROM collection in Lübeck was ethically approved • Data collection started in January 2021 Status report cont`d
6.4: Cancer surveillance and disease mapping
The aim of Activity 6.4 is to monitor cancer occurrence and outcomes through clinical cancer registry data and develop an online platform on cancer (="interactive cancer atlas") to present and track improvements in oncological care through epidemiological measures (e.g. survival).
• Manuscript on breast cancer survival in peer review at Cancer Epidemiology • 9 video calls were held • Exchange of results established (individual calculations) • Now undergoing further quality controls Status report cont`d
Smoothing-Process has been established
Aims: • Support interpretability • Remove random artefacts from the maps Status report cont`d
Age-standardised incidence rate
First impression: • Overall incidence comparable • Diagnosed stages are a bit lower in Denmark Status report cont`d
Relative 5-year Survival
First impression: • Overall survival is comparable in both countries • Regional differences (also stage-specific) under study Outlook – within CCC
• WP6-meeting alternatively video or telephone conferences • Finalize altered PREM/PROM-questionnaire in WP6.1 (layout, TeleForm and pre-test) • Obtain amendment vote for study planned in WP 6.2 • Carry out population-based survey (WP 6.2) in summer 2021 • Finalize breast cancer prototype and extend the atlas to more cancer sites (WP 6.4) Thanks for your attention! Midterm Conference – From the application
81 Midterm Conference - Discussion
1. Cancellation of the midterm conference due to Corona. 2. Small midterm conferences for each work packages with physical participation assisted by WP2. 3. A ”midterm” conference in connection to the next GA.
What do you think?
82 The Interreg6a 2021-27 Deutschland-Danmark program
The process towards a new Interreg6a program is still ongoing.
• Right now there is a public hearing regarding the priorities. • National approvals expected summer 2021 • Final approval by the EU commsion expected winter 2021. • The first application deadline is expected to be in Mai 2022.
83 Interreg6a Deutschland-Danmark: Highlights
The future Interreg6a program: An innovative Region Strengthening health care innovation and new technology and equal access to health care. • e-health and telemedicine to improve quality and access to health care in collaboration with patients. • Solution to improve shift from hospital treatment to primary care. • Collaboration between universities, research institutions and private companies in the region.
84 Future Interreg6a 2021-27 application?
The process towards a new Interreg6a application.
Phase 1: Lead partners in CCC will contact all current project partners in June/July this year for face-to-face discussions regarding: • New projects ideas for future collaboration • Commitment for the partners to a future collaboration
85 Summing up
Next CCC General Assembly: Suggested date: Thursday October 14th 2021. Place: • Meeting in person. • Will be hosted in Denmark. • There is a tradition to visit the different partners during the project period. • Please inform lead partner, if you would like to host the next GA6?
Miscellaneous
86 Work package meetings
Meeting time • 13:00 -14:00 hours
WP virtual meeting rooms • WP3: [email protected] • WP5: [email protected] • WP6: [email protected]
87 Thank you for your attention!
88 Changing Cancer Care wird gefördert mit Mitteln des Europäischen Fonds für regionale Entwicklung.
Changing Cancer Care finansieres af midler fra Den Europæiske Fond for Regionaludvikling.