Improving Sleep in Cancer Patients: A Feasibility Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.

Detailed Description
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This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.

Official Title
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Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Behavioral: CBT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years of age have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments) are diagnosed with gastro-intestinal cancer; have life expectancy > 6 months; are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure; will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I; are English-speaking and able to provide voluntary, written consent. Exclusion Criteria: unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment; other sleep disorders; bipolar disorder; unmanaged serious mental illnesses; suicidal ideation/intent/plan; unstabilized pharmacological treatment for insomnia; night-shift employment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving CBT-I<br>This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia). | Behavioral: CBT-I<br>* Eligible participants will receive CBT-I by a licensed clinical psychologist.<br>* Other names: cognitive behavioral therapy for insomnia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the score on the Insomnia Severity Index (ISI) | The ISI assesses the severity of insomnia symptoms and subjective daytime impairments. | baseline and at 19th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of diary-assessed sleep onset latency | Sleep onset latency is the time it takes to fall asleep | baseline and at 19th week | 
| Change of diary-assessed wake after sleep onset | wake after sleep onset is the total duration of nighttime awakenings | baseline and at 19th week | 
| Change of actigraphy-sleep onset latency | Sleep onset latency is the time it takes to fall asleep | baseline and at 19th week | 
| Change of actigraphy-assessed wake after sleep onset | wake after sleep onset is the total duration of nighttime awakenings | baseline and at 19th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, insomnia, CBT, CBT-I, cognitive behavioral therapy