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CTRI Number  CTRI/2017/06/008892 [Registered on: 21/06/2017] Trial Registered Prospectively
Last Modified On: 17/08/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Questionnaire Based Survey 
Study Design  Other 
Public Title of Study   To explore availability, costs involved and new ideas in Cancer care in India 
Scientific Title of Study   Cancer Care in India: Accessibility, Affordability, Innovation 
Trial Acronym  CCI  
Secondary IDs if Any  
Secondary ID  Identifier 
1896 Version No 2 dated 29-Mar-2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr C S Pramesh 
Designation  Professor and Surgical Oncologist  
Affiliation  Tata Memorial Centre 
Address  Room No 301, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24176310  
Fax  24154005  
Email  prameshcs@tmc.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr C S Pramesh 
Designation  Professor and Surgical Oncologist  
Affiliation  Tata Memorial Centre 
Address  Room No 301, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24176310  
Fax  24154005  
Email  prameshcs@tmc.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr C S Pramesh 
Designation  Professor and Surgical Oncologist  
Affiliation  Tata Memorial Centre 
Address  Room No 301, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24176310  
Fax  24154005  
Email  prameshcs@tmc.gov.in  
 
Source of Monetary or Material Support  
Wellcome Trust Gibbs Building 215 Euston Road London NW1 2BE United Kingdom 
 
Primary Sponsor  
Name  Wellcome Trust 
Address  Gibbs Building 215 Euston Road London NW1 2BE United Kingdom  
Type of Sponsor  Other [Global charitable foundation ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumitra Shankar Datta   Tata Medical Center  Department of Palliative Care and Psycho-oncology 14,MAR(E-W), New Town, Rajarhat, Kolkata, West Bengal-700156
Kolkata
WEST BENGAL 
03366057161
66057578
ssdatta2000@yahoo.com 
Dr C S Pramesh  Tata Memorial Hospital  Department Thoracic Disease Management Group Room No 301, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Dr. E Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA 
022-24177070
24154005
prameshcs@tmc.gov.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Tata Medical Center, Institutional Review Board  Approved 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Family Members of Cancer Patients 
Patients  Cancer Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Patient and family members at TMH will be recruited after written Consent process 
 
ExclusionCriteria 
Details  1 Patients and family members who are not physically and mentally fit will be excluded from the study
2 Relatives will not be interviewed if the patient wishes so.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To conduct an empirical study to evaluate availability of cancer care, affordability and access to cancer care in India  The study involves one time survey per participant. When the entire study is completed the data will be analysed and assessed. 
 
Secondary Outcome  
Outcome  TimePoints 
To take the first steps and generate robust empirical evidence for a better understanding of cancer and cancer care in India from the perspective of patients and family members
 
The study involves one time survey per participant. When the entire study is completed the data will be analysed and assessed. 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   01/08/2017 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Study Title: Accessibility, Affordability, Innovation.

Short Title: CCI Study

Background:

India has over one million new cancer patients every year. Facing a crisis that is rapidly emerging, experts have sounded a national alarm arguing that cancer has become one of the country’s greatest public health challenges. The CCI study will explore India’s cancer scenario. Recent Research suggests that the abundance of patients and the scarcity of resources have resulted in an unprecedented movement of people. Faced with a diagnosis of disease, people travel enormous distances across the country to access medical care and this movement has intensified the burden on hospitals in metropolitan regions. 

Aims:

The project has two main Research aims: 

1. To conduct an empirical study to evaluate availability of cancer care, affordability and access to cancer care in India. 

2. To take the first steps and generate robust empirical evidence for a better understanding of cancer and cancer care in India from the perspective of patients and family members and policy makers. 

Sample Size:

600 patients and their relatives will be recruited from the 2 Indian sites.

Study Design:

Observational Study-questionnaire based survey.

Study Methodology:

The proposed study is a Pilot study will focus on Tata Memorial Hospital in Mumbai and Tata Medical Center in Kolkata. The Co-Principal Investigators will work with Research Assistants and interview patients and family members based on questionnaire, which will be conducted after written Informed Consent is obtained. For this pilot study, participants able to understand either of these languages will be approached- English, Hindi, Marathi or Bengali. The study duration would be 8 months.

In the interviews, the Research Assistants will ask non-intrusive, open-ended questions and would not interrupt the narratives provided by the participants. This will give participants as much control as possible over what they want to talk about and when to shift the topic of conversation. All interviews will be tape-recorded and translated.

The Co-Principal Investigator or the Research Assistants will explain to participants that they are free to not answer any questions that are upsetting to them or make them uncomfortable, and that they can choose to terminate the interview at any time without giving a reason.

Data will be collected regarding the following: (a) Socio-demographic data (b) Qualitative data about patient mobility, accessibility and affordability

Statistical Analysis:

Data will be processed using the principles of grounded theory. When reviewing the data, repeated ideas, concepts, metaphors or elements become apparent, and are tagged with codes, which will be extracted from the data.

Sharing of Results:

At the end of the Research project, the PIs will make a presentation at TMH presenting preliminary results from the Research, so that individuals and the institution might benefit from the study. 

 

 
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