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

Primary Purpose

Cancer, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercise
Cognitive-behavioral therapy
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Physical exercise

    Cognitive-behavioral therapy

    Arm Description

    A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.

    A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Change in sleep efficiency (SE) index (%)
    total sleep time/total time spent in bed X 100 - from sleep diary
    Change in sleep onset latency (SOL) - from sleep diary
    time to sleep after lights out - from sleep diary
    Change in wake after sleep onset (WASO) - from sleep diary
    summation of nocturnal awakenings - from sleep diary
    Change in total sleep time (TST) - from sleep diary
    time in bed minus total wake time - from sleep diary
    Change in Fatigue Symptom Inventory total score
    A 15-item questionnaire measuring perceived fatigue. The total score ranges from 15 to 75.
    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.

    Full Information

    First Posted
    May 4, 2016
    Last Updated
    May 13, 2016
    Sponsor
    CHU de Quebec-Universite Laval
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02774369
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CHU de Quebec-Universite Laval

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Insomnia
    Keywords
    cancer, insomnia, sleep, physical exercise, aerobic, cognitive-behavioral therapy, self-help, RCT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical exercise
    Arm Type
    Experimental
    Arm Description
    A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.
    Arm Title
    Cognitive-behavioral therapy
    Arm Type
    Active Comparator
    Arm Description
    A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical exercise
    Intervention Description
    Individualized aerobic intervention program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive-behavioral therapy
    Other Intervention Name(s)
    CBT
    Intervention Description
    Psychological intervention combining behavioral, cognitive, and educational strategies
    Primary Outcome Measure Information:
    Title
    Change in Insomnia Severity Index total score
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Change in sleep efficiency (SE) index (%)
    Description
    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)
    Title
    Change in sleep onset latency (SOL) - from sleep diary
    Description
    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)
    Title
    Change in wake after sleep onset (WASO) - from sleep diary
    Description
    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)
    Title
    Change in total sleep time (TST) - from sleep diary
    Description
    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)
    Title
    Change in Fatigue Symptom Inventory total score
    Description
    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)
    Title
    Change in Hospital Anxiety and Depression Scale
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30053196
    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.
    Results Reference
    derived

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

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