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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 

 
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