Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-27 @ 8:52 AM
Study NCT ID:
NCT02774369
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia Severity Index total score', 'timeFrame': 'Pre-tx (at recruitment, T1); Post-tx (6 weeks after, T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'A 7-item questionnaire evaluating the perceived severity of sleep difficulties. The total score is the main outcome (ranging from 0 to 28).'}], 'secondaryOutcomes': [{'measure': 'Change in sleep efficiency (SE) index (%)', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'total sleep time/total time spent in bed X 100 - from sleep diary'}, {'measure': 'Change in sleep onset latency (SOL) - from sleep diary', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'time to sleep after lights out - from sleep diary'}, {'measure': 'Change in wake after sleep onset (WASO) - from sleep diary', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'summation of nocturnal awakenings - from sleep diary'}, {'measure': 'Change in total sleep time (TST) - from sleep diary', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'time in bed minus total wake time - from sleep diary'}, {'measure': 'Change in Fatigue Symptom Inventory total score', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', 'description': 'A 15-item questionnaire measuring perceived fatigue. The total score ranges from 15 to 75.'}, {'measure': 'Change in Hospital Anxiety and Depression Scale', 'timeFrame': 'Pre-tx (at recruitment; T1), post-tx (6 weeks after; T2), 3-month FU (T3), 6-month FU (T4)', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'insomnia', 'sleep', 'physical exercise', 'aerobic', 'cognitive-behavioral therapy', 'self-help', 'RCT'], 'conditions': ['Cancer', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '41170811', 'type': 'DERIVED', 'citation': 'Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.'}, {'pmid': '30053196', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of non-metastatic cancer\n* adjuvant treatments completed within the past 6 months\n* insomnia symptoms as defined by a score ≥ 8 on the Insomnia Severity Index\n* practicing less than 90 minutes of physical exercise per week\n* able to readily read and understand French\n* available during a consecutive 6-week period to complete the intervention\n* written permission from physician to engage in a physical exercise program\n\nExclusion Criteria:\n\n* severe cognitive impairments (e.g., diagnosis of Parkinson disease)\n* severe psychiatric disorder (e.g., severe major depression)\n* diagnosis of a sleep disorder other than insomnia (e.g., obstructive sleep apnea)\n* any contraindication for the practice of physical exercise'}, 'identificationModule': {'nctId': 'NCT02774369', 'briefTitle': 'Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)', 'orgStudyIdInfo': {'id': '2012-933, A12-04-933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical exercise', 'description': "A 6-week individualised, aerobic intervention program elaborated by a kinesiologist following a complete assessment of the individual's physical condition.", 'interventionNames': ['Behavioral: Physical exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive-behavioral therapy', 'description': 'A 6-week self-administered cognitive-behavioral therapy for insomnia composed of a 60-min video (DVD format) and 6 booklets.', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy']}], 'interventions': [{'name': 'Physical exercise', 'type': 'BEHAVIORAL', 'description': 'Individualized aerobic intervention program', 'armGroupLabels': ['Physical exercise']}, {'name': 'Cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Psychological intervention combining behavioral, cognitive, and educational strategies', 'armGroupLabels': ['Cognitive-behavioral therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Josée Savard', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}