Brief Behavioral Intervention for Insomnia During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
PRIMARY OBJECTIVE(S):
To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.
SECONDARY OBJECTIVE(S):
- To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
- To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 12 months
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
次要结局
- Brief Fatigue Inventory (BFI)(12 months)
- Comprehensive Trail Making Test (CTMT)(At baseline, post intervention, 6 months and 12 months)
- Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall(At baseline, post intervention, 6 months and 12 months)
- Controlled Oral Word Association Test (COWAT)(At baseline, post intervention, 6 months and 12 months)
- Clinical Assessment of Depression (CAD)(12 months)
- Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory(At baseline, post intervention, 6 months and 12 months)
- Mobile Cognitive Assessment Battery (MCAB)(At baseline, post intervention, 6 months and 12 months)
研究者
Oxana Palesh
Oxana Palesh PhD, MPH
Stanford University