| CTRI Number |
CTRI/2025/10/096264 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Sexual Concerns Among Cancer Patients in Palliative Care |
|
Scientific Title of Study
|
Proportion of patients with sexual concerns among cancer patients attending a palliative care outpatient department: A cross-sectional 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 |
Joshua Samuel |
| Designation |
Post graduate resident |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Room no 206, Department of pain and palliative care, 2nd floor, IORT block,SK campus, Cancer Institute (WIA) ,No 38, Sardar Patel
Road, Adyar, Chennai – 600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9500190933 |
| Fax |
|
| Email |
joshua.samuel3098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalpana Balakrishnan |
| Designation |
Head of department |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Room no. 218, Department of pain and palliative care, 2nd floor, IORT block, SK campus, Cancer Institute (WIA) ,No 38, Sardar Patel
Road, Adyar, Chennai – 600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9840158777 |
| Fax |
|
| Email |
b.kalpana@cancerinstitutewia.org |
|
Details of Contact Person
Public Query
|
| Name |
Joshua Samuel |
| Designation |
Post graduate resident |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Room no 206, Department of pain and palliative care, 2nd floor, IORT block, SK campus, Cancer Institute (WIA) ,No 38, Sardar Patel
Road, Adyar, Chennai – 600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9500190933 |
| Fax |
|
| Email |
joshua.samuel3098@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cancer institute WIA |
| Address |
No 38, Sardar Patel road, Adyar, Chennai |
| 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 |
| Meenakshi VV |
Cancer institute WIA |
Room no 206, Department of pain and palliative care, 2nd floor, IORT block, SK campus, no 38, Sardar Patel road, Adyar, Chennai
Chennai
TAMIL NADU |
9940370735
meenaram99@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
1) Cancer Patients of both genders above the age of 18, irrespective of diagnosis
2) Cancer Patients visiting the palliative care OPD
3) Histologically/cytologically confirmed case of cancer
4) Patients with good performance status (ECOG 1-2) |
|
| ExclusionCriteria |
| Details |
1) Patients with preexisting sexual dysfunction (Might interfere with the correlation of symptom burden with sexual issues)
2) Patients with a known psychiatric disorder and taking medications for the same (Anti psychotics and Antidepressants cause sexual dysfunction)
3) Patients not consenting for the study
4) Patients who don’t understand Tamil or English |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the proportion of patients with sexual concerns among the cancer patients attending the palliative care outpatient clinic
|
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To design & validate a culturally appropriate survey questionnaire to assess sexual concerns among cancer patients. |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
01/01/2026 |
| 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
|
Cancer and its treatments can have lasting effects on the body and daily life, including changes to appearance, speech, eating, and breathing. These challenges often affect confidence, relationships, intimacy, and sex life, which for a long time were overlooked by healthcare providers who focused mainly on treating the disease. Palliative care aims to support the whole person—physically, emotionally, socially, and spiritually—so it is important to talk about sexual health during visits. This study will start by asking patients short screening questions about sexual concerns. Later, a more detailed sexual health questionnaire will be developed, tested, and translated into Tamil to ensure it is accurate and easy to understand. Experts in palliative care, psychology, social work, and patient advocacy will review it. A small pilot test with patients will check if the questions are clear and relevant.
|