Clinical trial · Interventional
Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors
A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cognitive Impairment | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behaviour Therapy for Insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Behaviour Therapy for Insomnia (CBT-I)
- description
- Participants will receive individualized CBT-I delivered by video-conferencing over the course of eight weeks.
- interventionNames
- Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)
- type
- EXPERIMENTAL
- label
- Waitlist Control Group
- description
- 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.
- interventionNames
- Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 analysisReferences
Publications (5)
- DERIVEDCai 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
- DERIVEDGreeley 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
- DERIVEDGreeley 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
- DERIVEDGreeley 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
- DERIVEDGarland 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