Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03339518
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2017-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breast Cancer Recurrence Risk Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative Perceived Risk of Breast Cancer', 'timeFrame': '6 months', 'description': 'Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000).'}, {'measure': 'Absolute Perceived Risk of Breast Cancer', 'timeFrame': '6 months', 'description': 'Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.\n\nExclusion Criteria:\n\n* Women who are unable to read/write in English.'}, 'identificationModule': {'nctId': 'NCT03339518', 'acronym': 'BRIM3', 'briefTitle': 'Breast Cancer Recurrence Risk Counseling', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'BRIM3: Breast Cancer Recurrence Risk Informational Materials Project', 'orgStudyIdInfo': {'id': '1306056017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRIM3 Educational intervention', 'description': 'Individuals will receive a booklet and counseling about risk.', 'interventionNames': ['Behavioral: BRIM3 educational intervention']}, {'type': 'OTHER', 'label': 'Wait list Control', 'description': 'At the completion of the study, individuals in the wait list condition will receive a booklet.', 'interventionNames': ['Behavioral: Wait List']}], 'interventions': [{'name': 'BRIM3 educational intervention', 'type': 'BEHAVIORAL', 'description': 'Breast Cancer risk education and counseling', 'armGroupLabels': ['BRIM3 Educational intervention']}, {'name': 'Wait List', 'type': 'BEHAVIORAL', 'description': 'Booklet at the end of study', 'armGroupLabels': ['Wait list Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40505', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Kimberly Kelly, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '304-293-1453'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified data will be available upon written request is appropriate human subjects protections are in place, and the request does not conflict with the aims of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kentucky', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kimberly Kelly', 'investigatorAffiliation': 'West Virginia University'}}}}