Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT) (SHERE-Relief 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility as measured by percent attrition for the four teleCBT-I sessions
研究概览
简要总结
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Diagnosed with any stage of prostate cancer
- •Receiving androgen deprivation therapy
- •Able to speak and read English
- •Score >/= 8 on Insomnia Severity Index
排除标准
- •Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
- •Sleep apnea not utilizing/or adherent to CPAP
- •Uncontrolled restless legs syndrome
结局指标
主要结局
Feasibility as measured by percent attrition for the four teleCBT-I sessions
时间窗: Two months
Feasibility as measured by percentage of target sample enrolled
时间窗: Through study completion (an average of 24 months)
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
时间窗: Two months
次要结局
- Change from baseline for participants' sleep metrics for total sleep time (hours per night)(one month, two months)
- Change from baseline in sleep quality(one months, two months)
- Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)(one month, two months)
- Change from baseline in insomnia severity(one months, two months)
- Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life(one months, two months)
- Change from baseline for participants' ReadiScores(one month, two months)