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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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