| CTRI Number |
CTRI/2020/06/025784 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
QUESTIONNAIRE BASED SURVEY |
| Study Design |
Other |
|
Public Title of Study
|
To study the effects of digitalisation and decentralisation in cancer treatment |
|
Scientific Title of Study
|
Grid Oncology: Remaking Cancer Care in India |
| Trial Acronym |
G O Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C S Pramesh |
| Designation |
Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges Road Parel
Mumbai Maharashtra
India 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224168440 |
| Email |
cspramesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C S Pramesh |
| Designation |
Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges Road Parel
Mumbai Maharashtra
India 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224168440 |
| Email |
cspramesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C S Pramesh |
| Designation |
Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges Road Parel
Mumbai Maharashtra
India 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224168440 |
| Email |
cspramesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital
Dr E Borges Road Parel
Mumbai Maharashtra
India 400012
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KINGS COLLEGE LONDON |
The Strand
London WC2R 2LS
United Kingdom
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Kannan |
Cachar Cancer Hospital and Research Centre |
N S Avenue Meherpur
Silchar Assam 788015
Cachar
ASSAM |
9854040424
ravi.kannan@cacharcancerhospital.org |
| Dr Satyajit Pradhan |
Mahamana Pandit Madan Mohan Malviya Cancer Centre & Homi Bhabha Cancer Hospital |
Varanasi
Uttar Pradesh 221005
Varanasi
UTTAR PRADESH |
9105422575035
satyajit.pr@gmail.com |
| Dr C S Pramesh |
Tata Memorial Hospital |
Dr E Borges Marg Parel
Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA |
02224176310
02224168440
cspramesh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Cachar Hospital |
Approved |
| Institutional Ethics Committee of MPMMMCC & HBCH |
Approved |
| Institutional Ethics Committee of Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients and family members who are not physically and mentally fit will be excluded from the study. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Doctors nurses administrators patients and family members will be approached for participating in the study after written consent process |
|
| ExclusionCriteria |
| Details |
Patients and family members who are not physically and mentally fit will be excluded from the study
Relatives will not be interviewed if the patient wishes so
Age: below 18 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To generate rich empirical accounts of India’s National Cancer Grid and its efforts to decentralize, standardize and digitalize oncology |
ONE TIME INTERVIEW |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To document the intended and unintended consequences of these efforts for doctors nurses administrators patients and family members |
ONE TIME INTERVIEW |
|
|
Target Sample Size
|
Total Sample Size="900"
Sample Size from India="900"
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)
|
01/09/2020 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE AS OF NOW |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cancer has been recognized
as an important and growing public health concern in low- and middle-income
countries. In India, the annual number of new cases is projected to increase to
almost 2 million over the next 15 years. In 2012 India’s flagship cancer
hospital, Tata Memorial Hospital in Mumbai, made a step change and responded to
the rapidly growing number of patients. Supported by other public sector cancer
centers, Tata Memorial launched the National Cancer Grid of India to
decentralize, standardize, and digitalize oncology. Since 2012, 150 centers
have joined the grid, covering 60% of all cancer patients in the country.
The
project contributes to a better social scientific understanding of cancer care
in India. The project will help improve the prevention and control of an
important non-communicable disease in India. It will establish a new platform
for social science research collaborations. |