Association of caregiver's burden and mental health status in caregivers of patients with cancer from central rural India: a mixed-method study protocol.

Cancer impacts not only patients but also their family caregivers in India, who bear emotional, physical, and financial burdens of care.

• Family caregivers face overwhelming stress, anxiety, and depression, particularly in rural areas with limited healthcare access.
• Cultural expectations often lead caregivers to neglect their own well-being.
• Many caregivers are forced to reduce work or quit jobs, worsening financial strain.
• Despite their vital role, caregivers are described as 'largely overlooked in cancer care discourse.'

The study employs a sequential explanatory mixed-methods design combining quantitative and qualitative phases.

• The quantitative phase involves a cross-sectional survey using systematic random sampling.
• Data will be collected via a semistructured questionnaire and standardised tools.
• The qualitative phase will involve in-depth interviews with purposively selected caregivers.
• Integration of quantitative and qualitative findings is intended to provide 'a comprehensive understanding of caregiver burden and mental health, reflecting both measurable patterns and the human experience of caregiving.'

The Copenhagen Burnout Inventory will be used to assess burnout levels among caregivers.

• This is one of two standardised tools selected for the quantitative phase.
• It is used alongside the Depression, Anxiety and Stress Scale-21 (DASS-21).
• Statistical analysis will include descriptive statistics and regression analysis.

The Depression, Anxiety and Stress Scale-21 (DASS-21) will be used to evaluate psychological distress in caregivers.

• DASS-21 is one of two standardised tools selected for the quantitative phase.
• It will be administered alongside the Copenhagen Burnout Inventory.
• The study setting is Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, in central rural India.

Qualitative interviews will explore lived experiences, coping mechanisms, and emotional challenges of caregivers.

• Interviews will be conducted with purposively selected caregivers.
• Interviews will be transcribed and analysed using thematic content analysis.
• This phase follows the quantitative survey phase in the sequential explanatory design.

Ethical clearance for the study protocol was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research.

• Approval number: DMIHER(DU)/IEC/2025/436.
• Permission for data collection was granted by both the institutional ethics committee and Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha.
• The study is registered under CTRI/2025/08/093357.
• Findings will be disseminated through peer-reviewed scientific journal publications and by engaging relevant stakeholders.