An Observational study to identify the issues and challenges in cancer patients on active treatment during the COVID-19 Pandemic and the resulting Lockdown

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

**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 Hindi 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.

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.