AzTrials
AzTrials

CancerNCT04026048

Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

A study testing Cognitive Behaviour Therapy for Insomnia (CBT-I) in people with Cancer and Insomnia, run by Memorial University of Newfoundland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Insomnia, Cognitive Impairment
What is being tested?
Cognitive Behaviour Therapy for Insomnia (CBT-I)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteCanada
Study dates
1 Sep 2019to 30 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Memorial University of Newfoundland

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

Other trials in Canada

About this study

Official title: A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) 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.

Read the 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).

Being tested
Cognitive Behaviour Therapy for Insomnia (CBT-I)
Keywords
Cognitive Behaviour Therapy for Insomnia, CBT-I, Cancer, Insomnia, Sleep, Perceived Cognitive Impairment
Medical subject headings
Neoplasms, Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behaviour Therapy for Insomnia (CBT-I)Behavioural

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

Study groups in NCT04026048
Study groupRoleWhat they receive
Cognitive Behaviour Therapy for Insomnia (CBT-I)ExperimentalParticipants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.
Receives: Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)
Waitlist Control GroupExperimentalParticipants 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.
Receives: Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (13)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Jan 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04026048
Sponsor's protocol ID
20200427
Other IDs
PJT 162428
Status last verified
Mar 2025
First submitted
4 Jul 2019
Last updated
6 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PubMed 41170811
  • Greeley KM, Lee RM, Tulk J, Harding SV, Yi Y, Aubrey-Bassler K, Garland SN. Recording and reporting of adverse events during a randomized controlled trial of cognitive behavioural therapy for insomnia (CBT-I) among cancer survivors. Sleep Sci Pract. 2025;9(1):10. doi: 10.1186/s41606-025-00129-8. Epub 2025 May 10.

    PubMed 40352744
  • Greeley KM, Rash J, Tulk J, Savard J, Seal M, Urquhart R, Thoms J, Laing K, Fawcett E, Garland SN. Factors associated with significant improvement in cancer-related fatigue after completing cognitive behavioral therapy for insomnia in cancer survivors. Support Care Cancer. 2025 Apr 28;33(5):432. doi: 10.1007/s00520-025-09482-x.

    PubMed 40295384
  • Greeley KM, Rash J, Tulk J, Savard J, Seal M, Urquhart R, Thoms J, Laing K, Fawcett E, Garland SN. Impact and mechanisms of cognitive behavioral therapy for insomnia on fatigue among cancer survivors: a secondary analysis of a randomized controlled trial. Sleep. 2025 Jun 13;48(6):zsaf014. doi: 10.1093/sleep/zsaf014.

    PubMed 39826090
  • Garland SN, Tulk J, Savard J, Rash JA, Browne S, Urquhart R, Seal M, Thoms J, Laing K. Randomized Controlled Trial of Virtually Delivered Cognitive Behavioral Therapy for Insomnia to Address Perceived Cancer-Related Cognitive Impairment in Cancer Survivors. J Clin Oncol. 2024 Jun 10;42(17):2094-2104. doi: 10.1200/JCO.23.02330. Epub 2024 Mar 29.

    PubMed 38552188

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behaviour Therapy for Insomnia (CBT-I) in people with Cancer and Insomnia, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026048, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in