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Completed

NCT Number: NCT02774369

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

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.

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Key information

Conditions

Cancer Behavior Dyssomnias Insomnia Mental Disorders Motor Activity Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Behavioral

Individualized aerobic intervention program

Cognitive-Behavioral Therapy

Behavioral

Psychological intervention combining behavioral, cognitive, and educational strategies

Other names: CBT

Primary outcomes

  1. Change in Insomnia Severity Index total score

    Time frame: 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 outcomes

  1. Change in sleep efficiency (SE) index (%)

    Time frame: 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

  2. Change in sleep onset latency (SOL) - from sleep diary

    Time frame: 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

  3. Change in wake after sleep onset (WASO) - from sleep diary

    Time frame: 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

  4. Change in total sleep time (TST) - from sleep diary

    Time frame: 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

  5. Change in Fatigue Symptom Inventory total score

    Time frame: 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.

  6. Change in Hospital Anxiety and Depression Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 17, 2016
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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