Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Sleep
研究概览
简要总结
This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.
详细描述
This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.
In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.
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
- Single (Outcomes Assessor)
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
- •Prostate cancer
- •Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
- •Over 18-yers old
- •Understand oral and written Danish
- •Written informed consent
排除标准
- •Medical assessment that does not allow aerobic exercise
- •Severe cognitive problems
- •Night work during the interventions period
- •Exercise training more than three times a week
结局指标
主要结局
Sleep
时间窗: Change from baseline sleep at 12 weeks
Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group
次要结局
- Quality of life(Baseline, 12 weeks, 6 month)
- Stress(Baseline, 12 weeks, 6 month)
- Physical activity(Baseline, 12 weeks)
- Insomnia(Baseline, 12 weeks, 6 month)
- Fatigue(Baseline, 12 weeks, 6 month)
- Depression(Baseline, 12 weeks, 6 month)
- Cardiorespiratory fitness(Baseline, 12-weeks)
- Anxiety(Baseline, 12 weeks, 6 month)
- Sleep quality(Baseline, 12 weeks, 6 month)
- Sleep pattern(Baseline, 12 weeks, 6 month)
研究者
Christoffer Johansen
Professor
Danish Cancer Society