NCT04712604已完成不适用
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
适应症
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
- Feasibility of the intervention
研究概览
简要总结
The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
- •18 years or older
- •able to speak/read English at the 5th grade level
- •having a consistent partner who is involved in daily activities including sleep
- •having 5 or greater score on the Pittsburgh Sleep Quality Index.
- •Sleep partners:
- •18 years or older
- •able to speak/read English at the 5th grade level
- •a partner of the patient who is involved in the patient's daily activities including sleep
- •having similar circadian rhythm/sleep patterns with the patient
- •having 5 or greater score on the Pittsburgh Sleep Quality Index.
排除标准
- •Patients and their sleep partners:
- •having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
- •having active suicidality in the past year
- •currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
- •currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
- •having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
- •unable to see or hear
- •at the end of life (life expectancy of less than a month)
- •unwilling to change their current sleep-related habits in near future.
结局指标
主要结局
Feasibility of the intervention
时间窗: 4 weeks
Feasibility of the intervention will be reported as the percentage of participants who enroll and complete all the sessions of the study.
Acceptability of the intervention
时间窗: 4 weeks
Acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and the interventionist as "satisfactory" or better.
次要结局
- Change in sleep disturbance(Baseline, 4 weeks)
- Change in quality of life(Baseline, 4 weeks)
研究者
Youngmee Kim
Professor
University of Miami
研究点 (2)
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