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

NCT02774369 | Completed

• 1 other identifier: 2012-933, A12-04-933
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer; Insomnia

Keywords

cancer; insomnia; sleep; physical exercise; aerobic; cognitive-behavioral therapy; self-help; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in sleep efficiency (SE) index (%)

  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

  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

  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

  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

  Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)

Study Arms (2)

Physical exercise

EXPERIMENTAL

A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.

Behavioral: Physical exercise

Cognitive-behavioral therapy

ACTIVE COMPARATOR

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

Interventions

Physical exercise BEHAVIORAL

Individualized aerobic intervention program

Physical exercise

Cognitive-behavioral therapy BEHAVIORAL

Psychological intervention combining behavioral, cognitive, and educational strategies

Also known as: CBT

Cognitive-behavioral therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Related Publications (2)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

• 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.

  PMID: 30053196 DERIVED

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share