Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change of the score on the Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.
详细描述
This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18+ years of age
- •have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments)
- •are diagnosed with gastro-intestinal cancer;
- •have life expectancy > 6 months;
- •are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure;
- •will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I;
- •are English-speaking and able to provide voluntary, written consent.
排除标准
- •unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment;
- •other sleep disorders;
- •bipolar disorder;
- •unmanaged serious mental illnesses;
- •suicidal ideation/intent/plan;
- •unstabilized pharmacological treatment for insomnia;
- •night-shift employment.
研究组 & 干预措施
Receiving CBT-I
This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).
干预措施: CBT-I (Behavioral)
结局指标
主要结局
Change of the score on the Insomnia Severity Index (ISI)
时间窗: baseline and at 19th week
The ISI assesses the severity of insomnia symptoms and subjective daytime impairments.
次要结局
- Change of diary-assessed sleep onset latency(baseline and at 19th week)
- Change of actigraphy-sleep onset latency(baseline and at 19th week)
- Change of actigraphy-assessed wake after sleep onset(baseline and at 19th week)
- Change of diary-assessed wake after sleep onset(baseline and at 19th week)
研究者
Sivan Rotenberg
Assistant Professor
Dartmouth-Hitchcock Medical Center