| CTRI Number |
CTRI/2025/10/095638 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [questionnare based study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a New Communication Questionnaire in South Indian Languages for Cancer Patients at JIPMER |
|
Scientific Title of Study
|
Validation of South Indian Language Translations of the EORTC QLQ-COMU26 Questionnaire and pilot testing in Cancer Patients Attending RCC OPD, JIPMER. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ambedkar yadala |
| Designation |
Assistant Professor |
| Affiliation |
Radiation Oncology |
| Address |
Building No-7, radiation oncology Office , RCC Block Jipmer Campus
Building No-7, radiation oncology Office , RCC Block Jipmer Campus
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940866067 |
| Fax |
|
| Email |
ambioncologist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambedkar yadala |
| Designation |
Assistant Professor |
| Affiliation |
Radiation Oncology |
| Address |
Building No-7, radiation oncology Office , RCC Block Jipmer Campus, dhanvantri nagar
Building No-7, radiation oncology Office , RCC Block Jipmer Campus, Dhanvamntrinagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940866067 |
| Fax |
|
| Email |
ambioncologist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ambedkar yadala |
| Designation |
Assistant Professor |
| Affiliation |
Radiation Oncology |
| Address |
Building No-7, radiation oncology Office , RCC Block Jipmer Campus, Dhanvantrinagar
Building No-7, radiation oncology Office , RCC Block Jipmer Campus, Dhanvantrinagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940866067 |
| Fax |
|
| Email |
ambioncologist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure support given by JIPMER puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER HOSPITAL |
| Address |
JIPMER PUDUCHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ambedkar yadala |
JIPMER |
RCC Block Jipmer Campus
Building no-7
Pondicherry
PONDICHERRY |
08940866067
ambioncologist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for observational studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing treatment for cancer |
| Patients |
, (1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
questionare |
EORTC COMU 26 QUESTIONNARE TO ASSESS THE COMMUNICATION IN ONCOLOGY TO BE ADMINSTERED ONCE ON EACH PATIENT AND THE STUDY DURATION IS 6 MONTHS. EACH PATIENT WILL BE GIVEN A QUESTIONNARE AND ASSESSSED ONLY ONCE. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS WHO REGISTERED FOR CANCER TREATMENT OR DIAGNOSIS ATLEAT 1 MONTH BEFORE |
|
| ExclusionCriteria |
| Details |
patients who are visiting for the first time |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VALIDATION OF QUESTIONNARE IN REGIONAL LANGUAGES |
ONE TIME AT OPD during THE STUDY PERIOD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/10/2025 |
| 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="0"
Months="6"
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
|
The EORTC QLQ-COMU26 questionnaire was translated into four South Indian languages (Telugu, Tamil, Malayalam, Kannada) following the EORTC translation guidelines. The process involved forward and backward translations, reconciliation by bilingual experts, and review by the translation coordinator. Pilot testing was conducted with 10 cancer patients fluent in each target language (total n=40) at the Regional Cancer Centre, JIPMER. Patients completed the translated questionnaire and provided structured feedback on clarity, comprehensibility, and cultural appropriateness. Overall, the translations were well understood. Minor difficulties were reported in a few questions (e.g., Q4, Q5, Q13 in Telugu), where patients suggested alternative wording. After team discussion, reconciled versions were retained to preserve conceptual equivalence with the original EORTC items. The final versions were thus confirmed to be clear, culturally relevant, and conceptually faithful to the source questionnaire, making them suitable for use in clinical and research settings among South Indian cancer populations. |