Self-help Treatment for Insomnia in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- sleep diary indices, actigraphy, Insomnia Severity Index
研究概览
简要总结
The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be receiving treatment for a diagnosis of breast or gynaecological cancer
- •To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week
排除标准
- •To have received a diagnosis or being treated for :
- •a sleep disorder other than insomnia (e.g., sleep apnea)
- •a severe psychiatric disorder (e.g., psychotic disorder)
- •a severe cognitive disorder (e.g., dementia)
结局指标
主要结局
sleep diary indices, actigraphy, Insomnia Severity Index
时间窗: pre-treatment, post-treatment, 3 follow-up
次要结局
- EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs(pre-treatement, post-treatment, 3 follow-up)