Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

NCT04026048 | Completed Results DMC

• 2 other identifiers: 20200427PJT 162428
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Insomnia; Cognitive Impairment

Keywords

Cognitive Behaviour Therapy for Insomnia; CBT-I; Cancer; Insomnia; Sleep; Perceived Cognitive Impairment

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (13)

• The Insomnia Severity Index (ISI)

  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

• 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

• 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

Study Arms (2)

Cognitive Behaviour Therapy for Insomnia (CBT-I)

EXPERIMENTAL

Participants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.

Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)

Waitlist Control Group

EXPERIMENTAL

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.

Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)

Interventions

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.

Cognitive Behaviour Therapy for Insomnia (CBT-I); Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Memorial University of Newfoundland

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

Location

Related Publications (5)

• 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.

  PMID: 41170811 DERIVED

• 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.

  PMID: 40352744 DERIVED

• 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.

  PMID: 40295384 DERIVED

• 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.

  PMID: 39826090 DERIVED

• 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.

  PMID: 38552188 DERIVED

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Clinical trials using a waitlist condition generally inflate treatment effects; Use of waitlist control precluded comparing groups on long-term outcomes; Close to half of the patients in this trial were long-term cancer survivors, which may reduce the ability to attribute their functioning to their cancer diagnosis or treatments; The improvements observed in cancer-related cognitive impairment are only generalizable to patients who have insomnia and cognitive impairment.

Results Point of Contact

• Title: Dr. Sheila Garland
• Organization: Memorial University of Newfoundland

sheila.garland@mun.ca

(709) 864-4897

Study Officials

• Sheila N Garland, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology and Oncology at Memorial University of Newfoundland

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 19, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: June 30, 2023
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)