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

introductionCancer remains a growing public health challenge in India, impacting not only patients but also their caregivers, often family members who bear the emotional, physical and financial burdens of care. These family 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 recognise 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 patients with cancer in central rural India. In the quantitative phase, a cross-sectional survey will be conducted using systematic random sampling. Data will be collected via a semistructured questionnaire and standardised 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 regression analysis.The qualitative phase will involve in-depth interviews with purposively selected caregivers to explore lived experiences, coping mechanisms and emotional challenges. Interviews will be transcribed and analysed 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 setting. ETHICS AND DISSEMINATION: Ethical clearance for this study protocol was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research, Sawangi (Meghe), Wardha (Approval No. DMIHER(DU)/IEC/2025/436). Permission for data collection was further granted by both the institutional ethics committee and Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha. The findings of this research will be disseminated through publications in peer-reviewed scientific journals and by engaging relevant stakeholders through appropriate channels of communication. TRIAL REGISTRATION NUMBER: CTRI/2025/08/093357.