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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
CBT-I is a manualized multi-component intervention that includes sleep restriction, stimulus control, cognitive restructuring, relaxation training, and sleep hygiene.
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
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
Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
The Insomnia Severity Index (ISI)
The ISI is designed to specifically assess the severity of insomnia symptoms, the impact on daytime functioning, and the amount of associated distress. The ISI has 7 questions, which are summed to compute a total score. The range of the ISI is 0-28 with the higher the value, the more severe the insomnia severity.
Time frame: 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)
Sleep efficiency is the percentage of time spent asleep while in bed. It is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes). The unit of measure is a percentage and is averaged over the whole week for the total sleep efficiency score.
Time frame: 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)
The sleep diary will be used to calculate sleep-onset latency, which is the length of time that it takes to accomplish the transition from full wakefulness to sleep. The unit of measure is minutes and is averaged over the whole week for the total sleep onset latency score.
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Time frame: 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)
The sleep diary will be used to calculate wake after sleep onset, which refers to periods of wakefulness occurring after defined sleep onset. The score is reported in minutes and is averaged over the whole week for the total wake after sleep onset.
Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Total Sleep Time Measured by The Consensus Sleep Diary (CSD):
The sleep diary will be used to calculate total sleep time. The score is reported in minutes and is averaged over the whole week for the total sleep time.
Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression will be measured using the HADS, which is a 14-item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Scores range from 0-21 with below 7 indicating a non-case and the higher the score indicates greater symptom severity.
Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Fatigue will be measured using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from -24 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
The Hopkins Verbal Learning Test-Revised (HVLT-R)
The Hopkins Verbal Learning Test-Revised (HVLT-R) is a brief assessment of verbal learning and memory (immediate recall, delayed recall, delayed recognition). When scoring the HVLT-R, the three learning trials are combined to calculate a total recall score; the delayed recall trial creates the delayed recall score; the retention (%) score is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. These scores are then converted to an age-based T score (Mean=50, SD=10). Higher scores represent better verbal learning and memory.
Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
The Controlled Oral Word Association Test (COWAT)
The COWAT is a measure of verbal fluency, cognitive and motor speed, cognitive flexibility, strategy utilization, suppression of interference, and response inhibition. The total score is the total number of different words produced for all three letters in a timeframe of 3 minutes (1 minute for each letter). The scores are adjusted based on age and education level. A greater score indicates better verbal fluency. A score less then 33 indicates below average performance, scores between 34 and 45 indicate average performance, and scores greater than 45 are above average, with scores greater than 52 indicate superior performance. A minimum score is 0 (no words produced) and there is no set maximum score, as it depends on how many words can be produced in the given time frame.
Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
The Digit Span
The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scale (WMS). Part A of digit span (the forward span) captures attention efficiency and capacity, and part B (the backward span) is an executive task dependent on working memory. The Digit Span subtest will be scored as one summary value. The unit of measure is the total recall. Scores on this measure range from 0-48, where greater scores indicates greater attention efficiency, capacity and working memory.
Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A)
The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A) is composed of 75 items within nine non-overlapping theoretically and empirically derived clinical scales. It has 2 broad indexes (Behavioural Regulation and Metacognition), an overall summary score, and three validity scales. This analysis examines the overall summary score. T scores (M = 50, SD = 10; transformations of the raw scale scores) are used to interpret the individual's level of executive functioning. Traditionally, T scores at or above 65 are considered clinically significant. Greater scores indicate greater deficits in executive functioning.
Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
The Work Productivity and Activity Impairment (WPAI)
The WPAI questionnaire was developed for the purpose of collecting productivity loss data within clinical trials and is suitable for direct translation into a monetary figure. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
Credibility/Expectancy Questionnaire (CEQ)
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire that captures both credibility beliefs and outcome expectancy. Questions on this scale are rated on a 1-to-9 point or 0-100% Likert scale, depending on the exact question. The scale was adapted to separately assess: (1) credibility beliefs for insomnia; (2) credibility beliefs for PCI; (3) expectancy beliefs for insomnia; and (4) expectancy beliefs for PCI. Since the CEQ utilizes two scales during the administration (1-9, and 0-100%), a composite score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor yielding total scores, where higher values indicate stronger credibility and expectancy beliefs. Credibility beliefs scores ranged from 0 to 23 and expectancy beliefs scores ranged from 0 to 27.
Time frame: Baseline