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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Insomnia
• Intervention / Treatment: Behavioral: Physical exercise; Behavioral: Cognitive-behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical exercise; A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.	Behavioral: Physical exercise; Individualized aerobic intervention program
Active Comparator: Cognitive-behavioral therapy; 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; Psychological intervention combining behavioral, cognitive, and educational strategies; Other Names: CBT

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval

Publications and helpful links

General Publications

• Mercier J, Ivers H, Savard J. A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy149.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: sleep; cancer; insomnia; RCT; aerobic; physical exercise; cognitive-behavioral therapy; self-help
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2012-933, A12-04-933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO