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CTRI Number  CTRI/2024/01/062071 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A multinational study to evaluate financial difficulties of patient for breast cancer treatment. 
Scientific Title of Study   Burden of financial toxicity in Breast Cancer patients treated with curative intend: a multi-national study from low-middle income countries (FIT Study). 
Trial Acronym  FIT 
Secondary IDs if Any  
Secondary ID  Identifier 
4232- Version 2 dated 20/09/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tabassum Wadasadawala 
Designation  Professor and Consultant Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, 11th floor, Homi Bhabha Block, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India

Mumbai
MAHARASHTRA
400012
India 
Phone  2224177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tabassum Wadasadawala 
Designation  Professor and Consultant Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, 11th floor, Homi Bhabha Block, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India

Mumbai
MAHARASHTRA
400012
India 
Phone  2224177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Tabassum Wadasadawala 
Designation  Professor and Consultant Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, 11th floor, Homi Bhabha Block, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India

Mumbai
MAHARASHTRA
400012
India 
Phone  2224177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Source of Monetary or Material Support  
Intramural funds from Tata Memorial Centre. Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India 
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 
Dr Tabassum Wadasadawala  Tata Memorial Hospital  Tata Memorial Hospital, Breast OPD 105 and 108 Radiation Oncology, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 2224177026

twadasadawala@actrec.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  a. Pathologically confirmed new invasive breast cancer cases
b. Invasive breast cancer (AJCC 8th edition)
c. Received multi-modality treatment with curative intent.
d. Patient willing to provide all estimates of expenditure before and after coming to
the tertiary hospital, share relevant socio-demographic information and fill or respond to QOL instruments. 
 
ExclusionCriteria 
Details  a. Unable or unwilling to give written informed consent
b. Recurrent or metastatic disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Estimate of catastrophic health expenditure (CHE)  Single interview at the time of radiotherapy treatment planning and review of medical records.  
 
Secondary Outcome  
Outcome  TimePoints 
a. Proportion of quality indicators adversely affected
b. Study impact of FIT on quality of life using EQ5D5L and HADS.
c. Objective assessment of FIT using FACIT-COST questionnaire
d. Proportion of CHE using OOP expenditure greater than or equal to 40% of total
non-food expenditure of household definition
e. Proportion of patients facing medical impoverishment (MI) and economic
hardship (EC)
f. Study disease-related and socio-economic variables associated with FIT
g. Study disease-related and socio-economic variables associated with QOL  		 Single interview at the time of radiotherapy treatment planning and review of medical records.  
 
Target Sample Size   Total Sample Size="444"
Sample Size from India="222" 
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)   01/02/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Globally, breast cancer accounts for one-fourth of new cancer cases in women and is also the leading cause of cancer and cancer death in women from low-middle-income countries. Cancer treatment is an expensive affair as it entails higher direct costs and increases indirect costs due to out-of-pocket expenditure and wage loss. It has been found that cancer treatment poses a huge economic burden on the household and results in catastrophic spending which further results in impoverishment of the household. The inequitable distribution of cancer care leads to inaccessibility and unaffordability thereby causing diagnostic delay and inability to receive timely cancer treatment. Prolongation of treatment duration increases the indirect cost of food, travel, and accommodation in addition to loss of productivity. This study will provide an opportunity to assess the incidence of financial toxicity in breast cancer patients from different countries with similar socio-demographic profiles. It will help correlate the risk of financial toxicity with the key quality parameters of the respective cancer diagnostic and treatment modalities. Secondly, the study also aims at assessing quality of life which will be captured using standard instruments. This study will not interfere with the standard treatment of breast cancer. The study team will interview the patient and/or the person accompanying them to capture details concerning social, economic, and living conditions, household income, and medical expenditure incurred for breast cancer treatment. The interview will be conducted during radiotherapy planning or delivery sessions. Single-time assessment of quality of life will also be done. 
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