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
- 1
- 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
- •for individuals with non-hematological malignancies:
- •Men and women who are easily able to understand and read English
- •No current evidence of cancer or clinically stable/inactive disease
- •Received and completed all adjuvant treatments at least 6 months prior to study entry to allow for neural stabilization and recovery
- •Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
- •Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index (ISI)
- •Have good performance status as indicated by an Eastern Cooperative Oncology Group (ECOG) score of 0-2
- •Have high-speed internet connection, webcam, and are fluent using the internet
- •Inclusion Criteria for individuals with hematological malignancies:
- •Men and women who are easily able to understand and read English
- •A diagnosis of a hematological malignancy currently in remission
- •Completed cancer treatments including transplant, chemotherapy and/or immunotherapy at least 6 months prior to study entry
- •Self-reported PCI as indicated by a score of "sometimes" or higher ("quite a lot" or "always") on at least two out of three questions that assess memory, concentration, and attention
- •Meet the DSM-5 criteria for insomnia disorder and have a score of 8 or greater on the Insomnia Severity Index
- •Have good performance status as indicated by an ECOG score of 0-2
- •Have high-speed internet connection, webcam, and are fluent using the internet
排除标准
- •for individuals with and without hematological malignancies:
- •Another sleep disorder, besides insomnia, that is not adequately treated (ie: untreated obstructive sleep apnea)
- •The presence of another psychological disorder that is not currently stable and/or would impair the ability to participate in the study
- •A major sensory deficit (e.g. blindness)
- •A neurologic or major medical condition known to affect cognitive function (e.g., Parkinson's)
- •A history of cranial radiation
- •A history of any other condition that may affect cognitive functioning (e.g., traumatic brain injury)
- •Previous experience with CBT-I
- •Other considerations:
- •Participants will not be excluded for using psychotropic medication prior to study entry (e.g. antidepressants) provided that the dose was not recently altered (stable over the previous 6 weeks)
- •Considering the potential for prescription of medications to help with sleep (e.g. hypnotics, sedatives, and antidepressants) within the cancer population, medication use throughout the study will be tracked and adjusted for in the statistical analysis
研究组 & 干预措施
Cognitive Behaviour Therapy for Insomnia (CBT-I)
Participants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.
干预措施: Cognitive Behaviour Therapy for Insomnia (CBT-I) (Behavioral)
Waitlist Control Group
Participants in the waitlist control group will be required to monitor their sleep with sleep diaries for 7 weeks. They will receive CBT-I delivered by video-conferencing immediately after the waiting period.
干预措施: Cognitive Behaviour Therapy for Insomnia (CBT-I) (Behavioral)
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)
- 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 Hopkins Verbal Learning Test-Revised (HVLT-R)(Change from Baseline to 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