| CTRI Number |
CTRI/2025/02/079914 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The financial and family challenges faced by cancer patients receiving radiation therapy at a teaching hospital in coastal karnataka. |
|
Scientific Title of Study
|
The financial and family burden of cancer: Estimates from patients undergoing radiation therapy in a tertiary care teaching hospital in coastal karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deesha |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431777708 |
| Fax |
|
| Email |
deesha.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Healthcare and Hospital Management, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104 |
| Department of Radiotherapy Oncology, KMC, Manipal, Karnataka, India- 576104 |
|
|
Primary Sponsor
|
| Name |
Deesha |
| Address |
Department of Healthcare and Hospital Management, Prasanna School of Public Health, MAHE, Manipal, Karnataka, India- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajesh Kamath |
Kasturba Hospital |
Room No- 12 LINAC, Department of Radiotherapy Oncology, Shirdi Sai Baba Cancer Hospital and Research Center, KMC, Manipal- 576104
Udupi
KARNATAKA |
7760218342
rajesh.kamth@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who are currently undergoing active radiotherapy treatment for cancer.
- Patients with head and neck cancer, breast cancer, gastrointestinal cancers, and
gynaecological cancers.
- Patients aged 18 and above. |
|
| ExclusionCriteria |
| Details |
- Individuals who are only receiving follow-up care and not active treatment.
- Patients with cancers other than head and neck cancer, breast cancer, gastrointestinal cancers, and gynaecological cancers.
- Patients below 18 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To quantify the out-of-pocket costs and categorize them by the types incurred by
cancer patients during their treatment such as travel cost, prescription drugs and
in-home healthcare.
2. To compare differences in financial burden across various demographic factors
such as income, education, age, level of insurance coverage and tumor types
(head and neck tumors, breast tumors, gastrointestinal tumors, gynaecological
tumors).
|
10-15 minutes to complete the questionnaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess how patients and their families perceive the financial burden of these
out-of-pocket expenses using a Likert scale. |
10-15 minutes to complete the questionnaire |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/02/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is titled Financial and Family Burden of Cancer: Estimates from Patients Undergoing Radiation Therapy in a Tertiary Care Teaching Hospital in Coastal Karnataka. A hospital-based, cross- sectional study. Patients who are currently undergoing active radiotherapy treatment for cancer and Patients with head and neck cancer, breast cancer, gastrointestinal cancers, and
gynaecological cancers and Patients aged 18 and above will be recruited. The primary objective is to quantify the out-of-pocket costs and categorize them by the types incurred by
cancer patients during their treatment such as travel cost, prescription drugs and
in-home healthcare. The secondary objective of the study is to compare differences in financial burden across various demographic factors
such as income, education, age, level of insurance coverage and tumor types
(head and neck tumors, breast tumors, gastrointestinal tumors, gynaecological
tumors) and to assess how patients and their families perceive the financial burden of these
out-of-pocket expenses using a Likert scale. |