A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 386
- 主要终点
- Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7
研究概览
简要总结
RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors.
PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.
详细描述
OBJECTIVES:
Primary
- To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances,as measured by sleep latency or time to fall back asleep after initial sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer survivors.
Secondary
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline (week 1) and weeks 4 and 7 in these participants.
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the percentage of participants in each group who show improved sleep per the Pittsburgh Sleep Quality Index.
- To compare the effects of these interventions on fatigue, mood disturbance, sleep, benefit, and distress in this patient population.
- To describe the side effects associated with these interventions in these patients.
- To describe patient practice habits and adherence measured via a sleep behavior record.
- To explore symptom clusters in this patient population and look at distress as a mediating variable. (Exploratory)
- To explore predictors of sleep quality. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7
时间窗: Baseline and 7 weeks
The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" \> \> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.
次要结局
- Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.(Baseline and 7 weeks)
- Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)(Baseline and 7 weeks)
- Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)(At baseline and week 7)
- Distress at Week 6(From baseline to week 7)