| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family Members of Cancer Patients |
| Patients |
Cancer Patients, |
|
|
Intervention / Comparator Agent
|
|
|
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. |