Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Insomnia
研究概览
简要总结
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.
详细描述
The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
- •completed active treatment (surgery, radiation, chemotherapy) at least three months prior
- •within 5 years of treatment or still on adjuvant therapy
- •Completes informed consent to participate
排除标准
- •sleep apnea or restless leg syndrome
- •practicing mindfulness techniques >1/wk
研究组 & 干预措施
CBT-I
Cognitive Behavioral Therapy for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Mindfulness
Mindfulness-Based Therapy
干预措施: Mindfulness-Based Therapy (Behavioral)
结局指标
主要结局
Change in Insomnia
时间窗: Nine weeks
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
次要结局
- Change in Fatigue(Nine weeks)
- Change in Insomnia(Nine weeks)
- Change in cognitive function(Nine weeks)
研究者
Hannah Arem
Assistant Professor
George Washington University