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

Not Applicable
Completed
Conditions
Cancer
Insomnia
Interventions
Behavioral: Physical exercise
Behavioral: Cognitive-behavioral therapy
Registration Number
NCT02774369
Lead Sponsor
CHU de Quebec-Universite Laval
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Physical exercisePhysical exerciseA 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.
Cognitive-behavioral therapyCognitive-behavioral therapyA 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets.
Primary Outcome Measures
NameTimeMethod
Change in Insomnia Severity Index total scorePre-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 Outcome Measures
NameTimeMethod
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 sleep onset latency (SOL) - from sleep diaryPre-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 diaryPre-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 total sleep time (TST) - from sleep diaryPre-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

Change in Fatigue Symptom Inventory total scorePre-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 ScalePre-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.

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