Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
详细描述
A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
- •chronic insomnia
排除标准
- •Other preexisting sleep disorders except those with OSA stable on CPAP
- •Unstable medical illnesses
结局指标
主要结局
Insomnia Severity Index
时间窗: one month
One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.
次要结局
未报告次要终点
研究者
Suzanne Dickerson
Principal Investigator
State University of New York at Buffalo