| CTRI Number |
CTRI/2025/12/099160 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Psychological burden and quality of life among family caregivers of patients with advanced cancer in palliative care |
|
Scientific Title of Study
|
A prospective observational study for the evaluation of psychological burden and quality of life of family caregivers of patients with advanced cancer in palliative care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaheer Abdulla |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Ajmer |
| Address |
Department of Palliative Medicine
JLN Medical College
Kala Bagh,Near Patel Stadium
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9745905830 |
| Fax |
|
| Email |
shaheereabdulla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Garg |
| Designation |
Associate Professor & Head of Department |
| Affiliation |
Jawaharlal Nehru Medical College Ajmer |
| Address |
Department of Palliative Medicine
JLN Medical College
Kala Bagh Near Patel Stadium
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9829399322 |
| Fax |
|
| Email |
drdeepakgarg04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar Garg |
| Designation |
Associate Professor & Head of Department |
| Affiliation |
Jawaharlal Nehru Medical College Ajmer |
| Address |
Department of Palliative Medicine
JLN Medical College
Kala Bagh Near Patel Stadium
Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9829399322 |
| Fax |
|
| Email |
drdeepakgarg04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shaheer Abdulla |
| Address |
Ayyam Kulangara
Thikkodi PO
Kozhikode
Kerala
Pin 673529 |
| 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 |
| Dr Deepak Kumar Garg |
J.L.N Medical College |
Department of Palliative Medicine
Kala Bagh Near Patel Stadium
Ajmer
Ajmer
RAJASTHAN |
9829399322
drdeepakgarg04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary family caregivers aged above 18 years, of either gender, of patients diagnosed with advanced cancer and willing to participate in study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary family caregivers (spouse, child, sibling, or close relative) providing the majority of care to the patient who are histologically proven stage 3 and 4 cancer patients undergoing palliative treatment
Patients consenting to be enrolled in the study
Age more than 18 years |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psychological burden(HADS Anxiety and Depression scores) and Quality of Life(WHOQOL-BREF domain scores) of primary family caregivers of advanced
cancer patients admitted in palliative care unit.
|
Baseline(at Admission),4 weeks and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Changes in daily activity functioning of the family caregivers assessed with structured activity impact questionnaire
2 Social burden experienced by family caregivers assessed using a social support or burden subscale |
Baseline at admission 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
15/12/2025 |
| 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="0"
Months="3"
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
|
Advanced cancer profoundly affects not only patients but also their families. The disabling effects of advanced cancers and their treatments result in significant limitations in patient’s daily activities, necessitating substantial caregiving efforts.(1) The decrease in functional capacity in these patients is also a significant indicator of prognosis.(2) Even the most resilient caregivers are deeply affected by factors such as decreased life expectancy, the loss of a loved one, and the challenges of coping with imminent death.(3) Considering patients and their family caregivers as a unit of care is a fundamental principle of palliative care aimed at enhancing the well-being of both patients and their families.(4) Family caregivers serve as crucial support for patients and significantly influence their quality of life, yet they also experience their own burdens and needs due to the patient’s illnesses.(5) These caregivers may face mental, social, physical, and economic challenges, with their psychosocial burden intensifying as the patient’s diseases progress and death approaches, sometimes surpassing the burden on the patients themselves [6] The characteristics of cancer patients and their caregivers, along with various aspects of comprehensive care, influence the caregiving burden and overall quality of life.(7) As patient dependency grows, caregiver’s negative experiences also escalate, adding to their burden.(8) Family caregivers may encounter conflicts in social roles, strain in relationships, limitations in daily activities, and adverse effects on their physical and mental well-being.(9) The Research Question being what are the primary factors contributing to the psychological burden and quality of life of family caregivers of patients with advanced cancer in the palliative care unit. Addressing this research question is crucial as it will provide insights into the specific needs of caregivers at the beginning of palliative care. Understanding these needs will help in developing targeted interventions to support caregivers and improve their well-being, ultimately enhancing the quality of care provided to patients. The psychological well-being of family caregivers is essential for the effective care of patients with advanced cancer. By identifying the factors contributing to caregiver burden, this study will help in designing interventions that can alleviate this burden, improving the overall palliative care experience for both patients and caregivers.(1) Family caregivers of patients with advanced cancer often experience significant psychological burden. Studies have shown that caregivers are at a high risk of developing mental health issues due to the stress and demands of caregiving. In past research, a considerable percentage of family caregivers, ranging from 55% to 90%, have experienced moderate to severe distress at different stages of their loved one’s incurable cancer illnesses.(1) The psychological burden on caregivers can be attributed to various factors including emotional distress, physical exhaustion, financial strain, and lack of social support. The interplay of these factors exacerbates the caregiver’s stress levels, leading to mental health issues.(1) What is already known about the subject is that caregivers of cancer patients experience high levels of stress and anxiety. Lack of support and resources increases caregiver burden. Psychological interventions can help reduce caregiver burden but are underutilized. What we do not know is how the caregiver burden varies among different demographics and how it evolves over time. Additionally, the effectiveness of various psychological interventions is not well defined. This study seeks to identify and analyze key factors contributing to the psychological burden and quality of life of family caregivers at the start of palliative care. |