Clinical trial NCT04026048: Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors
Official title: A Randomized Controlled Trial of Online Cognitive Behavior Therapy for Insomnia (CBT-I) and Perceived Cognitive Impairment (PCI) in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Cognitive Impairment
Keywords: Cognitive Behaviour Therapy for Insomnia
CBT-I
Cancer
Insomnia
Sleep
Perceived Cognitive Impairment
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-07-19
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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

Primary outcomes:
measure: The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
Secondary outcomes:
measure: The Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Sleep Efficiency Measured by The Consensus Sleep Diary (CSD)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Sleep-onset Latency Measured by The Consensus Sleep Diary (CSD)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Wake After Sleep Onset Measured by The Consensus Sleep Diary (CSD)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Total Sleep Time Measured by The Consensus Sleep Diary (CSD):
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
timeFrame: Change from Baseline to Week 4, Week 8, 3 month follow up, 6 month follow up
measure: The Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
measure: The Controlled Oral Word Association Test (COWAT)
timeFrame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
measure: The Digit Span
timeFrame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
measure: The Behaviour Rating Inventory of Executive Function-Adult (BRIEF-A)
timeFrame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
measure: The Work Productivity and Activity Impairment (WPAI)
timeFrame: Change from Baseline to Week 8, 3 month follow up, 6 month follow up
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Sheila N Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References: