| 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 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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GEETA KADAYAPRATH |
| Designation |
Head, Breast Surgical Oncology |
| Affiliation |
Max Super Speciality Hospital Patparganj |
| Address |
108 A, IP EXTENSION,
PATPARGANJ, NEW DELHI
East
DELHI
110092
India |
| Phone |
9810169286 |
| Fax |
|
| Email |
Geeta.Kadayaprath@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GEETA KADAYAPRATH |
| Designation |
Head, Breast Surgical Oncology |
| Affiliation |
Max Super Speciality Hospital Patparganj |
| Address |
108 A, IP EXTENSION,
PATPARGANJ, NEW DELHI
East
DELHI
110092
India |
| Phone |
9810169286 |
| Fax |
|
| Email |
Geeta.Kadayaprath@maxhealthcare.com |
|
Details of Contact 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 |
rajesh.saxena@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| MAX SUPER SPECIALITY HOSPITAL,
108 A, IP EXTENSION, PATPARGANJ, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
MAX SUPER SPECIALITY HOSPITAL |
| Address |
108 A, IP EXTENSION
PATPARGANJ
NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR GEETA KADAYAPRATH |
MAX SUPER SPECIALITY HOSPITAL |
ONCOLOGY DEPARTMENT, MAX INSTITUTE OF CANCER CARE,
108 A, IP EXTENSION, PATPARGANJ, NEW DELHI
East
DELHI |
9810169286
Geeta.Kadayaprath@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
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Intervention / Comparator Agent
|
|
|
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
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our study aims to identify the challenges faced by oncology patients during the pandemic. |
09-05-2020 to 30-06-2020 |
|
|
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 Enrollment (India)
|
09/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="22" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 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. |