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
- 193
- 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
- •DISEASE CHARACTERISTICS:
- •Prior diagnosis of cancer
- •At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy)
- •Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex)
- •Concurrent trastuzumab and maintenance rituximab allowed
- •Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week
- •No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in the year before cancer diagnosis
- •No active cancer (i.e., not considered no evidence of disease)
- •No concurrent CNS malignancy
- •No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Availability of a CD player and head or earphones
- •Ability to complete questionnaires
- •No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and Pain Scale)
- •No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record
- •No hot flashes that interrupt sleep
- •Not working overnight hours and unable to change schedule
- •No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for > 2 days
- •No prior experience with guided imagery or cognitive behavioral therapy for insomnia
- •No concurrent new herbal therapies
- •Stable dose of daily herbal supplements started ≥ 8 weeks before study intervention allowed
- •Herbal teas or herbs in various drink products allowed
- •No concurrent treatment with variable doses of any of the following:
- •Antidepressants
- •Anxiolytics
- •Pain medication (not including over the counter ad anti-inflammatory pain relievers)
- •Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently
排除标准
- 未提供
研究组 & 干预措施
Arm A: Home-based sleep intervention with Device #1
Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
干预措施: Home-based sleep intervention (Behavioral)
Arm B: Home-based sleep intervention with Device #2
Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
干预措施: Home-based sleep intervention (Behavioral)
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)