PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 10:27:46 GMT)

CTRI Number CTRI/2020/05/025070 [Registered on: 07/05/2020] - Trial Registered Prospectively Last Modified On 01/05/2020 Post Graduate Thesis No Type of Trial Observational Type of Study Cross Sectional Study Study Design Other Public Title of Study An Observational study to identify the issues and challenges in cancer patients on active treatment during the COVID-19 Pandemic and the resulting Lockdown Scientific Title of An Observational study to identify the issues and challenges in cancer patients on active treatment Study during the COVID-19 Pandemic and the resulting Lockdown Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name DR GEETA KADAYAPRATH Trial Coordinator (multi-center study) Designation Head, Breast Surgical Oncology Affiliation Max Super Speciality Hospital Patparganj Address 108 A, IP EXTENSION, PATPARGANJ, NEW 110092 Phone 9810169286 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name DR GEETA KADAYAPRATH Query) Designation Head, Breast Surgical Oncology Affiliation Max Super Speciality Hospital Patparganj Address 108 A, IP EXTENSION, PATPARGANJ, East DELHI 110092 India Phone 9810169286 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name RAJESH SAXENA Designation GENERAL MANAGER Affiliation Max Super Speciality Hospital Patparganj Address 108 A, IP EXTENSION, PATPARGANJ, NEW DELHI East DELHI 110092 India Phone 9818474003 Fax Email [email protected]

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Source of Monetary or Source of Monetary or Material Support Material Support > MAX SUPER SPECIALITY HOSPITAL, 108 A, IP EXTENSION, PATPARGANJ, NEW DELHI Primary Sponsor Primary Sponsor Details Name MAX SUPER SPECIALITY HOSPITAL Address 108 A, IP EXTENSION PATPARGANJ NEW DELHI Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DR GEETA MAX SUPER ONCOLOGY 9810169286 KADAYAPRATH SPECIALITY DEPARTMENT, MAX HOSPITAL INSTITUTE OF Geeta.Kadayaprath@m CANCER CARE, 108 axhealthcare.com A, IP EXTENSION, PATPARGANJ, NEW DELHI East DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 20/04/2020 No ETHICS COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Neoplasms Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 12.00 Year(s) Age To 98.00 Year(s) Gender Both Details i. Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020
ii. Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020
Exclusion Criteria Exclusion Criteria Details Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Our study aims to identify the challenges faced 09-05-2020 to 30-06-2020 by oncology patients during the pandemic.

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Secondary Outcome Outcome Timepoints N/A N/A Target Sample Size Total Sample Size=150 Sample Size from India=150 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 09/05/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=1 Days=22 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details

Brief Summary Title: “An Observational study to identify issues and challenges in cancer patients on active treatment during the COVID-19 Pandemic and the resulting Lockdown”

Protocol No: Onco_Covid-19

Version no:1.0

Version Date: 08 Apr 2020

Investigator: Dr. Geeta Kadyaprath

StudySite: Max Super Speciality Hospital, Patparganj, NewDelhi

Introduction:This is an Observational study by Oncology Department of Max Healthcare. In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life.Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.

Objectives: To do a prospective, cross-sectional, observational study of patients(who are either recently diagnosed with cancer or who want to Visit MICC either for treatment/ Follow up) to address the issues and challenges faced by them during Lockdown.

Primary Objective:Our study aims to identify the challenges faced by oncology patients during the pandemic.

Inclusion criteria

i. Registered with the Max Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020

ii. Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020

Selection and Enrollment of participants for Prospective Questionnaire based Survey:

Collection of data will be done through telephonic communication.

Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the

participant or attendant during telephonic verbal consent.

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Institutional Ethics Committee:

This protocol will be reviewed by the Institutional Ethics Committee and the study subjects will not be enrolled until the Committee/ Board has approved the protocol, as submitted or with modifications in subsequent version(s).

Publication of research findings:

After the completion of this study, we intend to immediately publish the results in international and national journals. In the Publication patients identity will not be revealed. Confidentiality of the subject would be maintained.

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