| CTRI Number |
CTRI/2025/12/098262 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how cancer patients feel about their doctors communication during radiation treatment |
|
Scientific Title of Study
|
Assessment of patients’ perception of communication with physicians among cancer patients receiving radiation therapy - A cross-sectional analytical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M J Kumari |
| Designation |
Professor cum principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research - [JIPMER] |
| Address |
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd., Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M J Kumari |
| Designation |
Professor cum principal (Ag), JIPMER |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research - [JIPMER] |
| Address |
Room no. 100, ground floor, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus Rd., Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jugamaya Devi |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research - [JIPMER] |
| Address |
Room no. 102, first floor College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus Rd., Gorimedu,Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
96789627822 |
| Fax |
|
| Email |
jugamayadevitez17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Intramural fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
| 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 M J Kumari |
JIPMER |
Room no. 86, ground floor, Radiation Oncology department, Regional Cancer Center, JIPMER, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
09894595420
kumari_mj@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Nursing Courses (Human Studies), JIPMER) |
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 |
Patient diagnosed with cancer (any site), receiving radiation therapy.
Patient who has received at least three sessions of radiation therapy.
Patient above 18 years of age.
|
|
| ExclusionCriteria |
| Details |
Patient with cognitive impairment
Patient receiving end of life care
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patients’ perception of communication with physicians among cancer patients receiving radiation therapy |
single assessment after patients receive radiation therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association between socio-demographic and clinical variables with patients’ perception of communication with physicians among cancer patients receiving radiation therapy. |
single assessment after patients receive radiation therapy |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
11/12/2025 |
| 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="1"
Months="0"
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 cross-sectional study focuses on assessing the perception of patients’ receiving radiation therapy on communication with their physicians using a validated tool EORTC QLQ-COMU26 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Communication Module 26), which is a cancer-specific communication questionnaire. It also looks into the association between socio-demographic and clinical variables with patients’ perception of communication with physicians. The study will be conducted in Regional Cancer Center of JIPMER after receiving approval from the Institue Ethical committee. Participants will be selected based on the predefined inclusion and exclusion criteria. Written informed consent will be taken from the participants. Socio-demographic and clinical data will be collected with a structured questionnaire and viewing the previous health records. Assessment of patients’ perception regarding communication with physicians is done by self-administration of EORTC QLQ-COMU26 questionnaire. Self-administered questionnaire would take 15-20 minutes to obtain data from each participant during the time of assessment. The study will provide insight into the gap existing in the patient- physician communication and findings can be used to develop and implement interventions needed to bridge this gap. |