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临床试验/CTRI/2025/08/093357
CTRI/2025/08/093357尚未招募不适用

Association of caregiver’s burden and mental health status in caregivers of cancer patients from Central Rural India: A Mixed-Method Study

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
290
试验地点
1
主要终点
Association of caregiver burden and mental health status in caregivers of cancer patients

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Must be informal unpaid primary caregivers aged 18 years or older
  • Individuals who have provided continuous caregiving for a minimum of six months will be included.
  • Caregivers who are willing to give written informed consent to participate in the study.

排除标准

  • Any paid or professional caregivers, including home health aides or nursing staff, to focus on the experiences of informal family caregivers.
  • Individuals who have provided care for less than six months, including those caring for patients newly diagnosed within the past half year.

结局指标

主要结局

Association of caregiver burden and mental health status in caregivers of cancer patients

时间窗: Assessment will be done in 12 months

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Divya Panicker

Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research

研究点 (1)

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