| CTRI Number |
CTRI/2025/10/095813 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lived experience of caregivers of older adults with cancer |
|
Scientific Title of Study
|
Lived experience of caregivers of older adults with cancer -a qualitative exploratory study in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lekhika Sonkusare |
| Designation |
Psycho Oncologist |
| Affiliation |
Tata Memorial Center |
| Address |
Department of Psycho oncology
Golden Jubilee building Room number 707 Tata Memorial Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9969895059 |
| Fax |
912224146937 |
| Email |
slekhika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lekhika Sonkusare |
| Designation |
Psycho Oncologist |
| Affiliation |
Tata Memorial Center |
| Address |
Department of Psycho oncology
Golden Jubilee building Room number 707 Tata Memorial Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9969895059 |
| Fax |
912224146937 |
| Email |
slekhika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lekhika Sonkusare |
| Designation |
Psycho Oncologist |
| Affiliation |
Tata Memorial Center |
| Address |
Department of Psycho oncology
Golden Jubilee building Room number 707 Tata Memorial Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9969895059 |
| Fax |
912224146937 |
| Email |
slekhika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr E Arnest Borges Marg Parel Mumbai- 400 012 Mumbai India.
Phone 91222417 7000
Fax 91222414 6937 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Arnest Borges road Parel Mumbai 400 012 India
Phone 91222417 7000 |
| 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 |
| Lekhika Sonkusare |
Tata Memorial Hospital |
Department of Psycho oncology
Golden Jubilee building Room number 707 Tata Memorial Hospital Mumbai
Mumbai
MAHARASHTRA |
9969895059
slekhika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Psycho social issues of caregivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of older adults diagnosed with cancer
Age of caregiver- 18 years and above
Caregivers who have been involved in providing care
Both primary and secondary caregivers (spouse, children)
Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Caregivers of individuals with terminal cancer who have less than 3 months of caregiving experience.
Non-family caregivers (e.g. hired professionals).
Caregivers with severe cognitive or psychiatric disorders that hinder communication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A deeper understanding of the caregiving experience for older adults with cancer in India |
Qualitative date will be collected through in-depth interviews during the study period. As this is an exploratory qualitative study, there ae no fixed time points such as baseline or follow up ;outcomes(themes and lived experiences) will be derived from the interview data collected once per participant. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An in-depth exploration of the psychological social emotional & spiritual issues along with practical challenges encountered by caregivers while supporting elderly patients |
Qualitative data will be collected through in-depth interviews during the study period. As this is an qualitative exploratory study, there are no fixed time points such as baseline or follow up ; outcomes (themes & lived experiences ) will be derived from the interview data collected once per participant |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/11/2025 |
| 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="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
|
Caregiving specially for older adults with cancer is really challenging . It has impact on physical ,psychological, emotional spiritual health of caregivers which lead poor quality of life . This study aims to explore and understand the lived experiences, challenges, and coping strategies of caregivers providing care to older adults with cancer in India. Using qualitative methods, in-depth interviews will be conducted with caregivers to capture their perspectives and emotional, physical, and social impact of caregiving. The findings will contribute to better support mechanisms and interventions tailored to caregiver’s needs in the Indian health care context. |