A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
研究概览
简要总结
The investigators will answer the question of whether treating insomnia using Cognitive Behavior Therapy for Insomnia (CBT-I) can improve perceived cognitive impairment (PCI) in cancer survivors compared to a waitlist control group. The investigators will recruit 124 people with insomnia and cognitive complaints who have completed cancer treatment at least 6 months prior to the study.
详细描述
The investigators will conduct a randomized controlled trial of immediate treatment with CBT-I compared to a delayed treatment group with 124 cancer survivors who have completed primary treatment at least 6 months prior and report PCI and insomnia. Participants who are randomized to the immediate treatment group will receive CBT-I over the course of seven weekly one hour sessions, after which the delayed treatment group will receive the intervention. Both groups will complete follow up assessments three and six months after completing treatment. PCI will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) as the primary outcome. To provide an objective assessment of cognition, the investigators have included the neurocognitive measures recommended by the International Cognition and Cancer Task Force. Other measures will include fatigue, anxiety, depression, and work productivity.
The investigators hypothesize that the online CBT-I group will report significantly greater improvements in perceived cognitive function compared to the waitlist control immediately post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained up at 6-months follow up (secondary endpoint).
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 —（Adult, Older Adult）
- 性别
- All
- 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
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
时间窗: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
The FACT-Cog was used to measure perceived cognitive impairment (PCI). It is a 37-item questionnaire with four cognitive subscales: perceived cognitive impairments, impact on quality of life, comments from others, and perceived cognitive abilities. Responses range from 0, ''never,'' to 4, ''several times a day,'' in the previous 7 days and negatively worded items are reverse scored to create subscale scores. Scores on the PCI subscale can range from 0 to 72 points, with a higher score indicative of better self-reported cognitive functioning and quality of life. A change of 5.9-points has been established as clinically meaningful change on the FACT-Cog PCI subscale
次要结局
- Total Sleep Time Measured by The Consensus Sleep Diary (CSD):(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- Sleep Efficiency Measured by The Consensus Sleep Diary (CSD)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- Sleep-onset Latency Measured by The Consensus Sleep Diary (CSD)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- The Insomnia Severity Index (ISI)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- Wake After Sleep Onset Measured by The Consensus Sleep Diary (CSD)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- The Hopkins Verbal Learning Test-Revised (HVLT-R)(Change from Baseline to Week 8, 3 month follow up, 6 month follow up)
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)(Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up)
- The Controlled Oral Word Association Test (COWAT)(Change from Baseline to Week 8, 3 month follow up, 6 month follow up)
- The Digit Span(Change from Baseline to Week 8, 3 month follow up, 6 month follow up)
- The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A)(Change from Baseline to Week 8, 3 month follow up, 6 month follow up)
- The Work Productivity and Activity Impairment (WPAI)(Change from Baseline to Week 8, 3 month follow up, 6 month follow up)
- Credibility/Expectancy Questionnaire (CEQ)(Baseline)
研究者
Sheila Garland
Associate Professor of Psychology and Oncology at Memorial University of Newfoundland
Memorial University of Newfoundland