| CTRI Number |
CTRI/2023/04/051523 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
estimate the standard cost of providing treatment for Gastric and Pancreatic cancer patients |
|
Scientific Title of Study
|
Study on cost of treatment of Pancreatic and Gastric cancer patients in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailesh V Shrikhande |
| Designation |
Professor & Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital department of surgical oncology 12th floor homibhaba block room number 1222 dr ernest borges marg parel mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shailesh V Shrikhande |
| Designation |
Professor & Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital department of surgical oncology 12th floor homibhaba block room number 1222 dr ernest borges marg parel mumbai
MAHARASHTRA 400012 India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shailesh V Shrikhande |
| Designation |
Professor & Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata memorial hospital department of surgical oncology 12th floor homibhaba block room number 1222 dr ernest borges marg parel mumbai
MAHARASHTRA 400012 India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital department of surgical oncology 12th floor room no 1222 homibhaba block dr ernest borges marg parel mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
dr ernest borges marg parel Mumbai |
| 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 |
| Shailesh V Shrikhande |
Tata Memorial Hospital |
Department of surgical oncology dr Ernest Borges Marg Parel
Mumbai MAHARASHTRA |
9820224761
shailushrikhande@hotmail.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: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Confirmed patients of Gastric and Pancreatic cancer visiting TMH
-Patients with written informed consent |
|
| ExclusionCriteria |
| Details |
Incomplete medical records
-Have other significant complicating conditions, including another cancer, major disability or deformity, poor mental function or other serious chronic diseases.
- Previously diagnosed with mental disorders or neurological diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To estimate the standard cost of providing treatment for gastric and pancreatic cancers in India
|
30 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To study the effect of early diagnosis and treatment on total duration of treatment and costs of cancer treatment for gastric and pancreatic cancer
-The potential of existing risk pooling mechanisms in covering the cost of gastric and pancreatic cancer
-To assess the financial onslaught of cancer on families of the patients
|
30 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Health care systems are increasingly burdened with the rising prevalence of cancer and high costs associated with the treatment of this chronic condition. The path towards universal level access to cancer care is real challenge in India’s health sector where the cost of health care in India is predominantly shared through out of pocket expenditure by the ailing person’s household (59 percent) and expenditure on health is equivalent to only 1.2 percent of India’s GDP (MOHFW 2019). As noted in the case of overall health care services (NSSO 2020), the for-profit private health care sector plays a major role in provisioning of cancer care treatment in India. Private health care sector in India provides 60 percent and 58 percent of cancer related inpatient and outpatient treatment respectively.Existing evidence in India shows the cancer affected households were at a risk of economic distress both out of financing of cancer care and due to wage loss arising out of less work participation, when compared other households. Economic burden associated with the cancer treatment is likely to have both short-term and long-term impact on welfare of the welfare of patient and family. The financial burden of cancer will be severe for patients who were economically active with dependent family members and were unable to work during/post treatment. Such patients with unexpected expenses due to cancer treatment is at a higher risk of anxiety, depression, and worse life quality. In this effort, we want to estimate the standard cost of providing treatment for stomach and pancreatic cancers in India and we want to study the dynamics of out of pocket expenditure. Further, this study will analyse the burden on caregiver and opportunity cost in gastric and pancreatic cancer patients in India. |