Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)

Study Overview
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Brief Summary
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It has been suggested that the practice of physical exercise can improve sleep, but few studies have investigated this issue in the context of cancer, despite the proven benefits of exercise in this population. This randomized-controlled trial (RCT) aimed to compare the efficacy of an aerobic intervention program to that of a self-administered cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and women with insomnia symptoms and treated within 6 months for a non-metastatic cancer participated in the study.

Official Title
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Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Behavioral: Physical exercise
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of non-metastatic cancer adjuvant treatments completed within the past 6 months insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index practicing less than 90 minutes of physical exercise per week able to readily read and understand French available during a consecutive 6-week period to complete the intervention written permission from physician to engage in a physical exercise program Exclusion Criteria: severe cognitive impairments (e.g., diagnosis of Parkinson disease) severe psychiatric disorder (e.g., severe major depression) diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea) any contraindication for the practice of physical exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise<br>A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition. | Behavioral: Physical exercise<br>* Individualized aerobic intervention program<br>|
| Active Comparator: Cognitive-behavioral therapy<br>A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets. | Behavioral: Cognitive-behavioral therapy<br>* Psychological intervention combining behavioral, cognitive, and educational strategies<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index total score | A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28). | Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep efficiency (SE) index (%) | total sleep time/total time spent in bed X 100 - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 
| Change in sleep onset latency (SOL) - from sleep diary | time to sleep after lights out - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 
| Change in wake after sleep onset (WASO) - from sleep diary | summation of nocturnal awakenings - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 
| Change in total sleep time (TST) - from sleep diary | time in bed minus total wake time - from sleep diary | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 
| Change in Fatigue Symptom Inventory total score | A 15-item questionnaire measuring perceived fatigue. The total score ranges from 15 to 75. | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 
| Change in Hospital Anxiety and Depression Scale | A 14-item questionnaire comprising 7 items assessing depression (HADS-D) and 7 items assessing anxiety (HADS-A). Scores obtained for each subscale range from 0 to 21. | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT