| CTRI Number |
CTRI/2025/08/093357 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method study |
| Study Design |
Other |
|
Public Title of Study
|
Mental health status of cancer patients caregivers from rural part of India |
|
Scientific Title of Study
|
Association of caregiver’s burden and mental health status in caregivers of cancer patients from Central Rural India: A Mixed-Method 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 |
Divya Panicker |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9408097923 |
| Fax |
|
| Email |
divya251198@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Abhishek Joshi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9403702453 |
| Fax |
|
| Email |
abhishekjoshi.psm@dmiher.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Divya Panicker |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9408097923 |
| Fax |
|
| Email |
divya251198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Divya Panicker |
Siddharth Gupta Memorial Cancer Hospital |
Department of Oncology, SGM Cancer Hospital Building, AVBRH Campus, Sawangi Meghe Wardha MAHARASHTRA |
9408097923
divya251198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessment of caregiver burden and Mental health status in caregivers of cancer patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Must be informal unpaid primary caregivers aged 18 years or older
2. Individuals who have provided continuous caregiving for a minimum of six months will be included.
3. Caregivers who are willing to give written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Any paid or professional caregivers, including home health aides or nursing staff, to focus on the experiences of informal family caregivers.
2. Individuals who have provided care for less than six months, including those caring for patients newly diagnosed within the past half year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of caregiver burden and mental health status in caregivers of cancer patients |
Assessment will be done in 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="290" Sample Size from India="290"
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)
|
15/09/2025 |
| 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="2" 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
|
Introduction: Cancer remains a growing public health challenge in
India, impacting not only patients but also their informal caregivers, often
family members who bear the emotional, physical, and financial burdens of care.
These caregivers face overwhelming stress, anxiety, and depression,
particularly in rural areas with limited healthcare access. Cultural
expectations often lead them to neglect their own well-being. Many are forced
to reduce work or quit jobs, worsening financial strain. Despite their vital
role, caregivers are largely overlooked in cancer care discourse. There is an
urgent need for India-specific, empathetic research and policies that support
caregiver health and recognize caregiving as a public health priority.
Methods and analysis: This study employs a sequential
explanatory mixed-methods design to examine the association between caregiver
burden and mental health status among informal caregivers of cancer patients in
central rural India. In the quantitative phase, a cross-sectional survey will
be conducted using purposive sampling. Data will be collected via a
semi-structured questionnaire and standardized tools: the Copenhagen Burnout
Inventory to assess burnout levels and the Depression, Anxiety, and
Stress Scale-21 to evaluate psychological distress. Statistical
analysis will include descriptive statistics and multivariable logistic
regression.
The
qualitative phase will involve In-Depth Interviews with a purposively
selected subgroup of caregivers to explore lived experiences, coping mechanisms,
and emotional challenges. Interviews will be transcribed and analyzed using
thematic content analysis. Integration of quantitative and qualitative findings
will provide a comprehensive understanding of caregiver burden and mental
health, reflecting both measurable patterns and the human experience of
caregiving in a rural oncology setting. |