Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-06 @ 12:44 PM
Study NCT ID:
NCT02986360
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2016-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Informed Implementation of Breast Density Reporting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of overall breast cancer risk', 'timeFrame': '1 month', 'description': 'electronic questionnaire developed by research staff'}, {'measure': 'Knowledge of breast density', 'timeFrame': '1 month', 'description': 'electronic questionnaire developed by research staff'}], 'secondaryOutcomes': [{'measure': 'Observed use of additional screening', 'timeFrame': '9 months of index mammogram', 'description': "Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Density, Breast Cancer Prevention']}, 'referencesModule': {'references': [{'pmid': '30091121', 'type': 'DERIVED', 'citation': 'Haas JS, Giess CS, Harris KA, Ansolabehere J, Kaplan CP. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification. J Gen Intern Med. 2019 Apr;34(4):591-597. doi: 10.1007/s11606-018-4622-4. Epub 2018 Aug 8.'}]}, 'descriptionModule': {'briefSummary': '1. To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers.\n2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening \\[i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer\\], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing screening mammography at participating hospital facility\n* normal mammogram result\n* no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer\n* must have email account\n\nExclusion Criteria:\n\n* non-English speaking\n* prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer\n* no email'}, 'identificationModule': {'nctId': 'NCT02986360', 'briefTitle': 'Informed Implementation of Breast Density Reporting', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Informed Implementation of Breast Density Reporting', 'orgStudyIdInfo': {'id': '2016P001411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vidscrip educational video', 'description': 'Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result', 'interventionNames': ['Behavioral: Vidscrip educational video']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density'}], 'interventions': [{'name': 'Vidscrip educational video', 'type': 'BEHAVIORAL', 'description': 'Vidscrip educational video provide to women', 'armGroupLabels': ['Vidscrip educational video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jennifer S Haas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Jennifer S. Haas, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}