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

NCT ID: NCT02774369

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical exercise

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

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: BEHAVIORAL

Individualized aerobic intervention program

Cognitive-behavioral therapy

A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets.

Group Type: ACTIVE_COMPARATOR

Cognitive-behavioral therapy

Intervention Type: BEHAVIORAL

Psychological intervention combining behavioral, cognitive, and educational strategies

Interventions

Physical exercise

Individualized aerobic intervention program

Intervention Type: BEHAVIORAL

Cognitive-behavioral therapy

Psychological intervention combining behavioral, cognitive, and educational strategies

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Josée Savard

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30053196 (View on PubMed)

Other Identifiers

2012-933, A12-04-933

Identifier Type: -

Identifier Source: org_study_id