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Completed

NCT Number: NCT04026048

Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1C 5S7, Canada

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cognitive Behaviour Therapy for Insomnia (CBT-I)

Behavioral

CBT-I is a manualized multi-component intervention that includes sleep restriction, stimulus control, cognitive restructuring, relaxation training, and sleep hygiene.

Primary outcomes

  1. 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

  1. The Insomnia Severity Index (ISI)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  2. Sleep Efficiency Measured by The Consensus Sleep Diary (CSD)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  3. Sleep-onset Latency Measured by The Consensus Sleep Diary (CSD)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  4. Wake After Sleep Onset Measured by The Consensus Sleep Diary (CSD)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  5. Total Sleep Time Measured by The Consensus Sleep Diary (CSD):

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  6. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  7. Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)

    Time frame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up

    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.

  8. The Hopkins Verbal Learning Test-Revised (HVLT-R)

    Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up

    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.

  9. The Controlled Oral Word Association Test (COWAT)

    Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up

    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.

  10. The Digit Span

    Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up

    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.

  11. The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A)

    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) 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.

  12. The Work Productivity and Activity Impairment (WPAI)

    Time frame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up

    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.

  13. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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