| CTRI Number |
CTRI/2026/03/106831 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess Stress and Challenges among Caregivers of Cancer Patients Receiving Supportive and Comfort Care |
|
Scientific Title of Study
|
Caregiver burden in caregivers of patients referred for Specialist Palliative Care at a tertiary care cancer center |
| 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 Jayita Deodhar |
| Designation |
Professor and Head of Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine
OPD No.75, Ground Floor,
Main Building,
Tata Memorial Hospital,
Dr. E. Borges Road,
Parel-East
Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9892358023 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor and Head of Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine
OPD No.75, Ground Floor,
Main Building,
Tata Memorial Hospital,
Dr. E. Borges Road,
Parel-East
Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9892358023 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayita Deodhar |
| Designation |
Professor and Head of Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine
OPD No.75, Ground Floor,
Main Building,
Tata Memorial Hospital,
Dr. E. Borges Road,
Parel-East
Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9892358023 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr. E. Borges Road, Parel-East Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges road Parel, Mumbai- 400012. |
| 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 Jayita Deodhar |
Tata Memorial Hospital |
Room No.75, Ground Floor,
Department of Palliative Medicine
Main Building,
Tata Memorial Hospital,
Dr. E. Borges Road,
Parel-East
Mumbai-400012
Mumbai
MAHARASHTRA |
9892358023
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-1 |
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 |
For Patients:
1. Age more than 18 years
2. Patients with advanced cancer (defined as stage 4/metastatic and recurrent cancers who have palliative intent of treatment)
3. Patients willing to give informed consent.
4. Able to comprehend Hindi/Marathi/English.
For Caregivers:
1. Caregivers of advanced cancer patients involved in caregiving for at least 3 months after histopathological/radiological diagnosis of cancer
2. Caregivers willing to give informed consent
3. Able to comprehend Hindi/Marathi/English
|
|
| ExclusionCriteria |
| Details |
For Patients:
1. Patients with severe psychiatric illness requiring inpatient/specialized care
For Caregivers:
1. Caregivers with severe psychiatric illness requiring inpatient/specialized care
2. Paid/formal caregivers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess caregiver burden of the primary family caregivers of patients with advanced cancer at baseline,6 weeks and 12 weeks |
Baseline, 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine caregiver burden amongst geriatric and adult primary family caregiver(s) of advanced cancer patients at baseline,6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
To assess caregiver burden amongst male and female primary family caregiver(s) of
patients with advanced cancer at baseline,6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
| To evaluate Quality of Life of primary family caregiver(s) of patients with advanced cancer at baseline,6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
To examine the psychological symptoms of primary family caregiver(s) of patients with
advanced cancer at baseline, 6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
To explore the association of quality of life and caregiver burden of primary family
caregiver(s) of patients with advanced cancer at baseline, 6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
| To evaluate the association of patient’s symptom burden and caregiver burden at baseline, 6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
To explore factors associated with caregiver burden of primary family caregiver(s) of
patients with advanced cancer at baseline,6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
| To define the role of caregiving of each informal caregiver involved in the patient’s care at baseline, 6 weeks and 12 weeks. |
Baseline, 6 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
04/04/2026 |
| 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 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
|
Cancer affects not only the patient but also the family members who provide day-to-day care. Caregivers of patients with advanced cancer often experience significant physical, emotional, social, and financial stress while supporting patients through treatment, symptom control, and frequent hospital visits. Patients referred for specialist palliative care usually have complex medical and supportive care needs, which can increase the responsibilities and strain experienced by their caregivers. The primary objective of this study is to assess the level of caregiver burden among caregivers of patients referred for specialist palliative care at a tertiary care cancer center. Secondary objectives include identifying demographic and clinical factors associated with increased caregiver burden.
This study will be conducted as an observational cross-sectional study in the Department of Palliative Medicine at a tertiary care cancer center. Adult caregivers (more than 18 years of age) who are identified as the primary caregiver of a patient with cancer referred for specialist palliative care, and who are willing to provide written informed consent, will be included in the study. Caregivers who are unable to understand or complete the questionnaire, or who decline participation, will be excluded. Data will be collected using validated caregiver burden assessment tools along with a structured questionnaire to record caregiver demographics and relevant patient characteristics.
The collected data will be analyzed to determine the prevalence and severity of caregiver burden and to explore factors that may influence caregiver stress. The findings of this study are expected to provide important insights into the challenges faced by caregivers in the palliative care setting. This may help identify caregivers at higher risk of stress and inform the development of supportive interventions and counseling services aimed at improving caregiver well-being and enhancing the overall quality of palliative care. |