Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Change in Insomnia Severity Index total score
研究概览
简要总结
It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of non-metastatic cancer
- •adjuvant treatments completed within the past 6 months
- •insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index
- •practicing less than 90 minutes of physical exercise per week
- •able to readily read and understand French
- •available during a consecutive 6-week period to complete the intervention
- •written permission from physician to engage in a physical exercise program
排除标准
- •severe cognitive impairments (e.g., diagnosis of Parkinson disease)
- •severe psychiatric disorder (e.g., severe major depression)
- •diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea)
- •any contraindication for the practice of physical exercise
结局指标
主要结局
Change in Insomnia Severity Index total score
时间窗: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)
A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28).
次要结局
- Change in sleep efficiency (SE) index (%)(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
- Change in sleep onset latency (SOL) - from sleep diary(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
- Change in wake after sleep onset (WASO) - from sleep diary(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
- Change in total sleep time (TST) - from sleep diary(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
- Change in Fatigue Symptom Inventory total score(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
- Change in Hospital Anxiety and Depression Scale(Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4))
研究者
Josée Savard
Researcher
CHU de Quebec-Universite Laval