Online Treatment of Cognitive Impairment and Insomnia in Cancer Survivors

Memorial University of Newfoundland

Status: Completed

Conditions: Cognitive Impairment; Insomnia; Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04026048

20200427

PJT 162428 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Cognitive Behaviour Therapy for Insomnia (CBT-I)

Experimental group

Description:

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

Treatment:

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

Waitlist Control Group

Experimental 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.

Treatment:

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