| CTRI Number |
CTRI/2025/10/095820 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Caregiver Burden in Family Caregivers of Cancer Patients |
|
Scientific Title of Study
|
Caregiver Burden And Quality Of Life Of Family Caregivers Of Cancer Patients On Best Supportive Care: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 |
Dr.Anu Jolly |
| Designation |
Post Graduate Resident |
| Affiliation |
Cancer Institute WIA,Adyar |
| Address |
Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36
Chennai
TAMIL NADU
600036
India |
| Phone |
9961933823 |
| Fax |
|
| Email |
anujolly4150677@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.V.V.Meenakshi |
| Designation |
Associate Professor and In-charge |
| Affiliation |
Cancer Institute WIA,Adyar |
| Address |
Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36
Chennai
TAMIL NADU
600036
India |
| Phone |
9940370735 |
| Fax |
|
| Email |
meenaram99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Anu Jolly |
| Designation |
Post Graduate Resident |
| Affiliation |
Cancer Institute WIA,Adyar |
| Address |
Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36
Chennai
TAMIL NADU
600036
India |
| Phone |
9961933823 |
| Fax |
|
| Email |
anujolly4150677@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36 |
|
|
Primary Sponsor
|
| Name |
Cancer Institute WIAAdyar |
| Address |
Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36 |
| 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 |
| DrANU JOLLY |
CANCER INSTITUTE WIA |
Room No. 206
Department Of Pain And Palliative Care,IORT Building,Second Floor,SK Campus,Cancer Institute WIA,NO.38 Sardar Patel Road,Adyar Chennai 36
Chennai
TAMIL NADU |
09961933823
anujolly4150677@gmail.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 |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Family caregivers of advanced cancer patients receiving supportive care at home who speak Tamil or English.
2.Caregivers who are providing voluntary care to the patient for physical health concerns in the context of cancer for more than 2 weeks without any financial compensation.
3.Caregivers who are defined as primary caregivers by the patient.
4.Caregivers aged over 18 and provide consent.
5.Patients who have been in home care for at least one month. |
|
| ExclusionCriteria |
| Details |
1.Caregivers of patients receiving any type of disease directed treatment.
2.Caregivers of patients receiving hospital or home based care.
3.Caregivers who are experiencing any sort of cognitive impairment.
4.Caregivers who did not provide consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the burden experienced by primary family caregivers of advanced cancer patients receiving home based supportive care |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To translate & validate the English version of CarerQol7D & use it to assess the quality of life of family caregivers.
2.To examine associations between caregiver burden & demographic factors (e.g., relationship to patient, education socioeconomic status).
3.To evaluate the correlation between patient symptom burden & caregiver burden.
4.To quantify caregiving activities & time allocation.
|
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Even though caregiver burden exists among cancer patients all over the world, literature regarding it is limited in a developing country like India.In home based setting , caregiver burden is high.As further research regarding the family caregiver burden and quality of life is essential, this study is going to be conducted.The CarerQol 7D tool will be translated into Tamil and used to assess the caregiver quality of life, Zarit burden interview for caregiver burden will be used to assess caregiver burden. A predesigned survey will be used to assess the time allocated for caregiving and other factors affecting caregiver burden. |