Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic

July 20, 2020 updated by: Max Healthcare Insititute Limited

An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Protocol No: Onco_Covid-19

Version no:1.0

Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown.

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110092
        • Recruiting
        • Max Superspeciality hospital, A Unit of Balaji Medical and Diagnostic Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will comprise all the cancer patients who are registered in the Max Superspeciality hospital, Patparganj between Nov 1st 2019 to Jan 31st 2020

Description

Inclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncology patients
Time Frame: 4-8 weeks
To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc
4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Healthcare Insititute Limited

Investigators

  • Principal Investigator: Geeta Kadayaprath, Max Hospital, Patparganj

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Onco_Covid-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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