Clinical trial NCT02774369: Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
Official title: Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Keywords: cancer
insomnia
sleep
physical exercise
aerobic
cognitive-behavioral therapy
self-help
RCT
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Insomnia Severity Index total score
timeFrame: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)
Secondary outcomes:
measure: Change in sleep efficiency (SE) index (%)
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
measure: Change in sleep onset latency (SOL) - from sleep diary
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
measure: Change in wake after sleep onset (WASO) - from sleep diary
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
measure: Change in total sleep time (TST) - from sleep diary
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
measure: Change in Fatigue Symptom Inventory total score
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.