Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT03444532
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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'}]}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep', 'timeFrame': 'Change from baseline sleep at 12 weeks', 'description': 'Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group'}], 'secondaryOutcomes': [{'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Baseline, 12-weeks', 'description': 'Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by the multidimensional fatigue inventory, to investigate change in fatigue from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by the Physical activity Questionnaire to investigate change in physical activity from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Depression', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by the Patient Health Questionnaireto, to investigate change in depression from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by the Generalized Anxiety Disorder Questionnaireto, to investigate change in anxiety from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Stress', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by Perceived Stress Scale to investigate change in stress from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by European Organization for Research and Treatment Cancer, to investigate change in quality of life from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Sleep quality', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by Pittsburgh Sleep Quality Index, to investigate change in sleep quality from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Sleep pattern', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by a sleep diary, to investigate change in sleep pattern from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Insomnia', 'timeFrame': 'Baseline, 12 weeks, 6 month', 'description': 'Measured by Insomnia Severity Index, to investigate change in insomnia from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measured by actigraphy, to investigate change in physical activity from baseline to 12 weeks and the difference in change between intervention - and the control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of Prostate', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.', 'detailedDescription': 'This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.\n\nIn total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer\n* Receiving treatment with androgen deprivation therapy or in combination with chemotherapy\n* Insomnia\n* Over 18-yers old\n* Understand oral and written Danish\n* Written informed consent\n\nExclusion Criteria:\n\n* Medical assessment that does not allow aerobic exercise\n* Severe cognitive problems\n* Night work during the interventions period\n* Exercise training more than three times a week'}, 'identificationModule': {'nctId': 'NCT03444532', 'briefTitle': 'Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Danish Cancer Society'}, 'officialTitle': 'Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia', 'orgStudyIdInfo': {'id': 'Sleep-Now'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12-week aerobic exercise and cognitive-behavioral therapy', 'description': '12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions', 'interventionNames': ['Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients assigned to the control group will receive usual care'}], 'interventions': [{'name': '12-week aerobic exercise and cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'description': '12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy', 'armGroupLabels': ['12-week aerobic exercise and cognitive-behavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Næstved', 'country': 'Denmark', 'facility': 'Oncology Department', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}], 'overallOfficials': [{'name': 'Christoffer Johansen, PhD, Dr.Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Cancer Society Research Center'}, {'name': 'Katrine Løppenthin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Cancer Society Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Cancer Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christoffer Johansen', 'investigatorAffiliation': 'Danish Cancer Society'}}}}