Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT03328169
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insomnia', 'timeFrame': 'Nine weeks', 'description': 'Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)'}, {'measure': 'Change in Insomnia', 'timeFrame': 'Nine weeks', 'description': 'Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)'}], 'secondaryOutcomes': [{'measure': 'Change in cognitive function', 'timeFrame': 'Nine weeks', 'description': 'Measured via the FACT-Cog (Scale 0-132; higher is better)'}, {'measure': 'Change in cognitive function', 'timeFrame': 'Nine weeks', 'description': 'Measured via the Montreal Cognitive Assessment (MOCA)'}, {'measure': 'Change in Fatigue', 'timeFrame': 'Nine weeks', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)'}, {'measure': 'Change in Insomnia', 'timeFrame': 'Nine weeks', 'description': 'Measured using an actigraph'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.', 'detailedDescription': 'The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer\n* completed active treatment (surgery, radiation, chemotherapy) at least three months prior\n* within 5 years of treatment or still on adjuvant therapy\n* Completes informed consent to participate\n\nExclusion Criteria:\n\n* sleep apnea or restless leg syndrome\n* practicing mindfulness techniques \\>1/wk'}, 'identificationModule': {'nctId': 'NCT03328169', 'briefTitle': 'Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '121635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CBT-I', 'description': 'Cognitive Behavioral Therapy for Insomnia', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Insomnia']}, {'type': 'EXPERIMENTAL', 'label': 'Mindfulness', 'description': 'Mindfulness-Based Therapy', 'interventionNames': ['Behavioral: Mindfulness-Based Therapy']}], 'interventions': [{'name': 'Mindfulness-Based Therapy', 'type': 'BEHAVIORAL', 'description': 'Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks.', 'armGroupLabels': ['Mindfulness']}, {'name': 'Cognitive Behavioral Therapy for Insomnia', 'type': 'BEHAVIORAL', 'description': 'A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature.', 'armGroupLabels': ['CBT-I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GW Center for Integrative Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hannah Arem', 'investigatorAffiliation': 'George Washington University'}}}}