| CTRI Number |
CTRI/2025/10/096130 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the financial burden and its effect on the Quality of Life among people living with cancer in central India |
|
Scientific Title of Study
|
Exploring Financial Toxicity and its Impact on Quality of Life and Well-being among Cancer Survivors in Central India: A Cross-sectional Patient-reported Outcome Study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh Raipur
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh Raipur
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Centre |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh Raipur
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| BALCO Medical Center, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661 |
|
|
Primary Sponsor
|
| Name |
Vedanta Medical Research Foundation |
| Address |
Balco Medical Centre, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Bhanwa Sirohi |
BALCO Medical Centre |
Room no 4, Medical Oncology,Ground floor, B wing, Sector 36, Atal Nagar, PO: Uparwara, Raipur, Chhattisgarh 493661
Raipur
CHHATTISGARH |
9756999976
bhawna.sirohi@vedanta.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMC-IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
i)Adult patients (aged 18 years and above) who have diagnosed with any form of cancer.
ii)Participants who are undergoing any form of cancer therapy (surgery, chemotherapy and radiation therapy) within the last 30 days.
iii)Patients willing to participate in the study and provide informed consent will be enrolled in this study.
|
|
| ExclusionCriteria |
| Details |
i) Severely ill patients (those who are bedridden or unable to communicate verbally) will be excluded.
ii) Patients who were diagnosed with significant mental and psychiatric comorbidities will be excluded from the study.
iii) Patients will be excluded if they have participated in other research trials/projects funded by external agencies, especially if they received financial compensation/support for their participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the financial burden and its impacts and distress among patients undergoing cancer treatment in a tertiary care cancer centre in Central India. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the association between financial toxicity, health-related quality of life (HRQOL), and psychological well-being among cancer patients. |
24 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
27/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Financial toxicity denoting the hardships faced by patients due to out of pocket expenses is gaining traction globally as well as in India. Cancer is a leading cause of mortality and morbidity and one of the most expensive healthcare conditions among Indian citizens. Research conducted among cancer survivors in India indicates that over 75 percent of cancer care expenses are borne by patients and their family members as out of pocket payments. In India’s healthcare system, OOPE is a major concern, with medicines accounting for a significant portion of expenses, followed by diagnostic tests and consultation fees. Studies suggest that escalating healthcare expenses are linked with psychological distress, lower treatment adherence, bankruptcy, and premature mortality among cancer patients. The majority of Indian households with cancer patients grapple with overwhelming healthcare expenses often resorting to borrowing from social networks and liquidating financial assets to cover the costs associated with cancer care. This study seeks to explore the significance of financial toxicity among cancer patients and its implications for their outcomes. |