Cancer, Insomnia
Conditions
Keywords
cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT
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.
Interventions
BEHAVIORALPhysical exercise
Individualized aerobic intervention program
BEHAVIORALCognitive-behavioral therapy
Psychological intervention combining behavioral, cognitive, and educational strategies
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index total score | Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4) | A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | time to sleep after lights out - from sleep diary |
| 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) | summation of nocturnal awakenings - from sleep diary |
| 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) | total sleep time/total time spent in bed X 100 - from sleep diary |
| 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) | A 15-item questionnaire measuring perceived fatigue. The total score ranges from 15 to 75. |
| Change in Hospital Anxiety and Depression Scale | Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4) | 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. |
| 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) | time in bed minus total wake time - from sleep diary |
Outcome results
None listed