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临床试验/CTRI/2025/03/081978
CTRI/2025/03/081978招募中2 期

Feasibility and Acceptance of Resilience-Based Intervention in Breast Cancer: A Pilot Study

Fogarty International Centre and National Institution of Mental Health, USA2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月1日最近更新:

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

发起方
Fogarty International Centre and National Institution of Mental Health, USA
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Annie Alexander

St Johns Research Institute

研究点 (2)

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