| CTRI Number |
CTRI/2019/07/020142 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of expenditure on breast cancer treatment in women undergoing treatment at tertiary cancer center |
|
Scientific Title of Study
|
Health expenditure on breast cancer treatment in women: a study from public sector tertiary
cancer centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259, Kharghar, Navi Mumbai, India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259, Kharghar, Navi Mumbai, India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Associate Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, PS 259, Kharghar, Navi Mumbai, India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| NAG FOUNDATION
C/O K K NAG PVT. LTD
15 SANGAM PROJECT Phase 2,
SANGAM BRIDGE ,
46 Dr AMBEDKAR ROAD
PUNE 411001 |
| WOMENS CANCER INITIATIVE, 610 / 611, Nirman Kendra, Famous Studio Lane,
Off Dr. E. Moses Road, Mahalaxmi, MUMBAI 400 012. |
|
|
Primary Sponsor
|
| Name |
Womens cancer initiative |
| Address |
610 / 611, Nirman Kendra, Famous Studio Lane,
Off Dr. E. Moses Road, Mahalaxmi,
MUMBAI 400 012. |
| Type of Sponsor |
Other [NGO] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NAG foundation NGO |
NAG FOUNDATION
C/O K K NAG PVT. LTD
15 SANGAM PROJECT Phase 2,
SANGAM BRIDGE ,
46 Dr AMBEDKAR ROAD
PUNE 411001 |
|
|
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 Centre (TMC) |
Tata Memorial Hospital, Room No:1117 Homi Bhabha Building, Radiation Oncology Department, Tata Memorial Hospital, Dr E Borges Road, Parel Mumbai, India 400012
Mumbai
MAHARASHTRA |
02224177000
02224146937
twadasadawala@actrec.gov.in |
|
|
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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Pathologically confirmed new invasive breast cancer cases
2) Non-metastatic invasive breast cancer (AJCC 8th edition)
3) Intending to receive entire treatment at TMC
4) Planned for multi-modality treatment comprising of surgery, chemotherapy and radiotherapy with or without hormone therapy or targeted therapy
5) Age > 18 years
6) Patient willing to provide all estimates of expenditure before and after coming to the tertiary hospital.
7) Patient willing to share relevant socio-demographic information.
8) Willing to fill or respond to QOL instruments.
|
|
| ExclusionCriteria |
| Details |
1) Unable or unwilling to give written informed consent
2) Inability to follow up after treatment completion.
3) Not willing for follow up till 2 years.
4) Recurrent or progressive disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of direct cost and out of pocket (OOP) expenditure incurred by women for breast cancer treatment at public sector tertiary care hospital in India. |
After the last accrued patient completes entire treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Mean difference in expenditure in INR between two categories of patients (general and private)
2) Proportion of patients in each category experiencing catastrophic expenditure (expenditure exceeding 10% of household income) in different cohorts. |
After the last accrued patient completes the treatment |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "708"
Final Enrollment numbers achieved (India)="708" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
11/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/03/2024 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The study has been published in the following articles:
1. https://pubmed.ncbi.nlm.nih.gov/38019238/
2. https://pubmed.ncbi.nlm.nih.gov/37116141/
3. https://pubmed.ncbi.nlm.nih.gov/36935486/
4. https://pubmed.ncbi.nlm.nih.gov/33773543/
5. https://www.thelancet.com/journals/lansea/article/PIIS2772-3682(23)00206-8/fulltext |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer is the leading cause of cancer and cancer death in Indian women. Cancer treatment poses a huge economic burden over the household and results in impoverishment of the household. Till date no study in India has looked at the amount of expenditure that the household incurs for treatment of breast cancer. This study aims to collect data on expenditure of treatment of breast cancer for patients who are registered at Tata Memorial Centre (TMC) and undergoing active treatment at TMC. Secondly, the study also aims at measuring the well-being of women and is captured using standard instruments like the EQ 5D, WHODAS and EORTC QLQ 30 & BR23. The study will not interfere with the standard treatment for breast cancer. The study team members will interview the patient or the person accompanying her for obtaining household details on social, economic and living conditions, household consumption and medical expenditure. A detailed medical and treatment history that the patient would undergo at TMC will be recorded. In addition, a detailed record of the spending for treatment will be maintained on regular basis. Data will be collected over a period of one year in order to capture the treatment period entirely. Patients will also be served the three instruments as mentioned earlier to get information about the impact of cancer treatment on daily activities and quality of life. |