Evaluating Internet-Based Interventions for Insomnia in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from cancer and experiencing symptoms of insomnia.
详细描述
The purpose of this study is to test the feasibility of using an Internet program to improve the sleep of cancer patients with insomnia. Participants will receive access to the Internet program (called SHUTi, or "Shut-Eye") as well as to self-hypnosis recordings designed to improve sleep. SHUTi provides an online, tailored educational program to individuals who are experiencing sleep difficulties, including those having difficulty falling asleep, waking in the middle of the night, and waking too early in the morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age = At least 21 years old
- •Regular access to the Internet, including e-mail
- •Cancer patient
- •Any type of cancer (EXCEPT non-melanoma skin cancer)
- •In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)
- •Insomnia diagnosis (combined from DSM-IV and ICSD):
- •Subjective complaints of poor sleep for at least 6 months
- •Sleep difficulties ≥3 nights/week
- •Difficulty falling asleep (≥30 minutes to fall asleep) OR
- •Difficulty staying asleep (≥30 minutes awake in the middle of the night)
- •≤6.5 hours sleep/night
- •Poor sleep causes marked distress or significant impairment in daytime functioning (e.g. fatigue, performance deficits, mood disturbance)
- •Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment
排除标准
- •Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)
- •Having a medical condition other than cancer that causes insomnia
- •Experiencing a psychiatric disturbance (major depression, psychosis)
- •Experiencing substance abuse
- •Currently undergoing psychotherapy or counseling
- •Changing sleep/anxiety/depression medication within the past month
- •Having an "unusual" sleep pattern
- •Normal bedtime is after 2am OR
- •Normal wake time is after 9am
- •Working as a shift worker (that is, having a schedule that requires working through the night)
- •Participants reports that she is pregnant or intending to get pregnant in the next 4 months
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Sleep Efficiency
时间窗: prior to intervention, after SHUTi use, after Hypnosis use
Sleep Diary: Total Sleep Time
时间窗: prior to intervention, after SHUTi use, after Hypnosis use
次要结局
- Sleep Diary: Sleep Onset Latency (SOL)(prior to intervention, after SHUTi use, after Hypnosis use)
- Sleep Diary: Wake After Sleep Onset (WASO)(prior to intervention, after SHUTi use, after Hypnosis use)
- Sleep Diary: Number of Nighttime Awakenings(prior to intervention, after SHUTi use, after Hypnosis use)
- Hospital Depression and Anxiety Scale(prior to intervention, after SHUTi use, after Hypnosis use)
- Pain scale(prior to intervention, after SHUTi use, after Hypnosis use)
- Multidimensional Fatigue Symptom Inventory(prior to intervention, after SHUTi use, after Hypnosis use)
- Quality of Life (SF-12 Health Survey)(prior to intervention, after SHUTi use, after Hypnosis use)
- Hot flashes(prior to intervention, after SHUTi use, after Hypnosis use)