Feasibility and Acceptance of Resilience-Based Intervention in Breast Cancer: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Resilience and Adherence to breast cancer treatment
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a Resilience-Based Intervention (RBI) among women living with breast cancer (WLBC) undergoing therapy at St. John’s Medical College Hospital and CAN-C Superspeciality Centre in Bengaluru. Fifty WLBC in the initial phase of breast cancer treatment will be purposively sampled and randomly assigned to either the experimental group (RBI) or waitlist control group (TAU). The RBI program comprises nine sessions focusing on psychoeducation, resilience-building through positive psychology constructs like gratitude and mindfulness, and cognitive-behavioral strategies to address psychological, social, and emotional challenges.
Outcomes will include resilience and adherence to breast cancer treatment, assessed pre-, post-intervention (3 months), and follow-up (4 months) after baseline. Secondary outcomes include mental health indicators such as distress, depression, quality of life, and posttraumatic growth. In-depth interviews with WLBC, family members, and healthcare professionals will explore the acceptability and cultural relevance of the RBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women Living with Breast Cancer (WLBC) are diagnosed with stage I, II, or III Breast Cancer (BC).
- •Currently undergoing BC therapy.
- •Fluent in English or Kannada.
排除标准
- •Individuals are unaware of their BC diagnosis.
- •Those with recurrent BC or previously diagnosed with other cancers.
- •Critically ill patients admitted to intensive care units.
- •Individuals with hearing or speech impairments.
结局指标
主要结局
Resilience and Adherence to breast cancer treatment
时间窗: pre-, post-intervention (3rd month) and follow-up (4th month) after the baseline assessment
次要结局
- Mental health - Distress, Depression, Quality of Life and Posttraumatic growth(pre-, post-intervention (3rd month) and follow-up (4th month) after the baseline assessment)
研究者
Annie Alexander
St Johns Research Institute
