| CTRI Number |
CTRI/2025/10/095809 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Payment from personal funds for Esophageal cancer treatment: A
multicentric study in Northeast India |
|
Scientific Title of Study
|
Out of Pocket Expenditure (OOPE) for Esophageal cancer treatment: A
multicentric study in Northeast India |
| Trial Acronym |
OOPEe |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Caleb Harris |
| Designation |
Additional Professor, Surgical Oncology |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong |
| Address |
212, Department of Surgical Onology, NEIGRIHMS, Mawdiangdiang, Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9969375606 |
| Fax |
|
| Email |
calebhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Caleb Harris |
| Designation |
PI, Additional Professor, Surgical Oncology |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong |
| Address |
Department of Surgical Onology, Main hospital block 2nd Floor, Room No- 212, NEIGRIHMS, Mawdiangdiang, Shillong 793018
Main hospital block 2nd floor
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9969375606 |
| Fax |
|
| Email |
calebhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Caleb Harris |
| Designation |
Additional Professor, Surgical Oncology |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong |
| Address |
212, Department of Surgical Onology, NEIGRIHMS, Mawdiangdiang, Shillong 793018
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9969375606 |
| Fax |
|
| Email |
calebhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study is fully funded by National Cancer Grid(NCG) which is part of Department of Atomic Energy, GoI |
|
|
Primary Sponsor
|
| Name |
National Cancer Grid |
| Address |
National Cancer Grid
Tata Memorial Hospital,
Tel:22-2417700, Extn-4266
9892706947 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Kannan |
Cachar Cancer Hospital and Research Centre, Silchar |
Mr. Debabrata Dutta, Administrative Oficer
Clinical Research Secretariat
Cachar Cancer Hospital and Research Center, Meherpur, Silchar, Assam, India – 788015
Cachar
ASSAM |
9854040424
ravi.kannan@cacharcancerhospital.org |
| Dr Anisha Mawlong |
Civil Hospital, Shillong |
Oncology Department, Main Civil Hospital, Room no 25-A, Laban, Lachumiere, Shillong, Meghalaya 793001
East Khasi Hills
MEGHALAYA |
9436924322
anishamawlong@gmail.com |
| Dr Abhijit Talukdar |
Dr. B. Borooah Cancer Institute and Research Insttitute |
Department of Surgical Oncology, AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar,Guwahati,Assam 781016
Kamrup
ASSAM |
07896059598
abhijit.talukdar881@gmail.com |
| Dr Caleb Harris |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
Dept of Surgical Oncology, Room no. 212,2nd Floor NEIGRIHMS,Mawdiangdiang Shillong-793018, Meghalaya, India
East Khasi Hills
MEGHALAYA |
9969375606
calebhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
Approved |
| CCHRC Institutional Review Board |
Approved |
| Institutional Ethics Committee Pasteur Institute |
Approved |
| Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
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 |
Patients undergoing treatment for esophageal cancer at the participating centres |
|
| ExclusionCriteria |
| Details |
a) Patients who declined.
b) Patients who are unable to provide details of the treatment expenditure.
c) Patients who receive palliative treatment only |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| How much is the OOPE incurred by patients who undergo Esophageal cancer treatment at NEIGRIHMS, Civil Hospital, BBCI, and Cachar Cancer Centre? |
How much is the OOPE incurred by patients at the time of diagnosis and various treatment modalities? (final assessment 4 weeks after Chemoradiotherapy or Surgery) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| How much is the Catastrophic Health Expenditure? |
At treatment completion(4 weeks after either Chemoradiation or Surgery) |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/11/2025 |
| 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 Yet Recruiting |
| 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
|
Treatment for esophageal(food pipe) cancer is multidisciplinary, meaning the patient will need surgery, chemotherapy and radiotherapy. Since the surgery is also complex, it involves a lot of expenditure. While the government has introduced insurance schemes to ensure free treatment, sometimes patients may have to pay partially for treatment. Even if treatment is free, patients may spend on travel, accommodation and other aspects, including the loss of livelihood for patients and the accompanying relatives. This study will collect information pertaining to the treatment expenditure of patients with esophageal cancer undergoing treatment at four centers of Northeast India (NEIGRIHMS, Civil Hospital Shillong, Dr. BBCI & Cachar Cancer Center) to estimate the out-of-pocket expenditure (OOPE) for esophageal cancer treatment. It will assess:
- Average OOPE per patient
- Impact of publicly financed health insurance on reducing costs
- Prevalence of catastrophic health expenditure (CHE) and distress financing
- OOPE as a proportion of Health Benefit Package costs
Approximately 400 patients will be surveyed using structured questionnaires to assess both medical and non-medical costs (direct/indirect) and funding sources. Data will be analysed using SPSS with appropriate statistical tests. The study aims to provide evidence for policymakers on the financial burden of esophageal cancer and gaps in financial protection in Northeast India.
|