N/A
N=132
Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors
Cancer · Insomnia · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04026048 ↗Enrolled (actual)
132
Serious AEs
3.0%
Results posted
Apr 2025
Primary outcome: Primary: The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3 — 39.39; 38.79; 48.28; 44.71 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behaviour Therapy for Insomnia (CBT-I) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial University of Newfoundland
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3 |
39.39; 38.79; 48.28; 44.71; 53.44; 43.00 | — |
| SECONDARY The Insomnia Severity Index (ISI) |
17.27; 15.06; 9.67; 9.77; 6.03; 6.34 | — |
| SECONDARY Sleep Efficiency Measured by The Consensus Sleep Diary (CSD) |
73.22; 74.03; 87.18; 88.10; 89.63; 89.33 | — |
| SECONDARY Sleep-onset Latency Measured by The Consensus Sleep Diary (CSD) |
40.56; 41.48; 16.68; 16.98; 12.68; 15.41 | — |
| SECONDARY Wake After Sleep Onset Measured by The Consensus Sleep Diary (CSD) |
63.29; 50.80; 23.32; 19.90; 21.84; 20.06 | — |
| SECONDARY Total Sleep Time Measured by The Consensus Sleep Diary (CSD): |
370.06; 378.41; 358.77; 376.08; 392.14; 406.40 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
7.90; 6.39; 4.45; 4.63; 3.14; 3.09 | — |
| SECONDARY Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) |
29.57; 26.64; 16.52; 17.17; 4.72; 6.05 | — |
| SECONDARY The Hopkins Verbal Learning Test-Revised (HVLT-R) |
49.84; 49.22; 49.11; 50.19; 54.25; 53.36 | — |
| SECONDARY The Controlled Oral Word Association Test (COWAT) |
47.14; 44.41; 46.77; 47.50; 51.04; 48.42 | — |
| SECONDARY The Digit Span |
28.49; 28.44; 30.11; 27.97; 30.73; 28.17 | — |
| SECONDARY The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A) |
60.37; 59.13; 51.14; 52.41; 50.13; 51.54 | — |
| SECONDARY The Work Productivity and Activity Impairment (WPAI) |
23.33; 18.28; 7.42; 11.54; 6.25; 5.85 | — |
| SECONDARY Credibility/Expectancy Questionnaire (CEQ) |
15.37; 16.43; 19.68; 20.28 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04026048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.