A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Memorial University of Newfoundland
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Sheila Garland
Associate Professor of Psychology and Oncology at Memorial University of Newfoundland
Memorial University of Newfoundland
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
Time Frame: 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
Secondary Outcomes
- 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)