Status:
COMPLETED
Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors
Lead Sponsor:
Memorial University of Newfoundland
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cancer
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 compa...
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04026048
Start Date
September 1 2019
End Date
June 30 2023
Last Update
April 6 2025
Active Locations (1)
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1
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1C 5S7