| CTRI Number |
CTRI/2025/07/090885 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing burden on caregivers residing in the same house as of cancer patients with their physical activity level using two scales. |
|
Scientific Title of Study
|
Comparing stress burden across different physical activity levels in
family caregivers of cancer patients: A Comparative 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 Abha Dhupkar |
| Designation |
Associate Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Community department DES Brijlal Jindal College of Physiotherapy Fergusson college campus Shivaji Nagar Pune Maharashtra India 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
8975632595 |
| Fax |
|
| Email |
abha.dhupkar@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Mandhane |
| Designation |
Post graduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Community department DES Brijlal Jindal College of Physiotherapy Fergusson college campus Shivaji Nagar Pune Maharashtra India 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9373200769 |
| Fax |
|
| Email |
drkomalmpt124@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Mandhane |
| Designation |
Post graduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Community department DES Brijlal Jindal College of Physiotherapy Fergusson college campus Shivaji Nagar Pune Maharashtra India 411004
Pune
MAHARASHTRA
411004
India |
| Phone |
9373200769 |
| Fax |
|
| Email |
drkomalmpt124@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Komal Mandhane |
| Address |
Community department DES Brijlal Jindal College of Physiotherapy Fergusson college campus Shivaji Nagar Pune Maharashtra India 411004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Komal Mandhane |
DES Brijlal Jindal college of physiotherapy |
Community department ground floor DES Brijlal Jindal college of physiotherapy fergusson college campus shivaji nagar pune 411004
Pune
MAHARASHTRA |
9373200769
drkomalmpt124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DESBJCOP Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of cancer patients |
|
|
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 |
1. Family members (spouses, children, siblings, relatives) providing care
to the patient.
2. Age 18+
3. Had been taking care of the patient for at least 1 month.
4. Resides in the same house as the patient.
5. The individual is able to understand English language. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Godin-Shephard
Leisure-Time Physical
Activity Questionnaire
2. Zarit Burden
Interview (ZBI)
(GSLTPAQ) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
01/08/2025 |
| 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 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
|
This study aims to evaluate and compare the levels of stress burden among family caregivers of cancer patients based on their physical activity levels The Zarit Burden Interview is used to assess caregiver stress while the Godin Leisure Time Physical Activity Questionnaire categorizes participants into low, moderate, and high activity groups By analyzing the association between physical activity and caregiver burden the study seeks to understand whether higher physical activity levels contribute to lower stress in caregivers thereby highlighting the potential role of movement in mental health support for this population |