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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Individualized aerobic intervention program
Psychological intervention combining behavioral, cognitive, and educational strategies
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).
Time frame: Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)
Change in sleep efficiency (SE) index (%)
total sleep time/total time spent in bed X 100 - from sleep diary
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)
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