Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04164251
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2019-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inpatient Screening Mammography for Non-adherent and High Risk Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-30', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women who underwent a screening mammography during hospitalization', 'timeFrame': 'Prior to hospital discharge, up to 1 year', 'description': 'Screening mammography is done during hospitalization. Proportion of women that get the screening will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer Screening', 'Mammography'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34229929', 'type': 'DERIVED', 'citation': 'Khaliq W, Siferd C, Kantsiper ME, Jacobs L, Howell EE, Wright SM. Capturing the Rest: Inpatient Mammography for Nonadherent Hospitalized Women. Am J Prev Med. 2021 Nov;61(5):709-715. doi: 10.1016/j.amepre.2021.04.026. Epub 2021 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to pilot a program that will evaluate the feasibility of an inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74 admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County General Hospital. The two key activities include: inpatient breast care education with educational handouts and offering inpatient screening mammography. Inpatient screening mammography will be offered to non-adherent (last screening mammogram more than 24 months ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot program will thus evaluate the feasibility of an inpatient screening mammography as an innovative approach to increase breast cancer screening among non-adherent and high risk women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'women between 50 and 74 years of age who were non-adherent to breast screening guidelines (USPSTF recommendations)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women between 50 and 74 years of age who were non-adherent to breast screening guidelines\n\nExclusion Criteria:\n\n* Patients with a history of breast cancer or mastectomy\n* history of other cancers (except skin)\n* serious comorbidities making patient's life expectancy \\<10 years"}, 'identificationModule': {'nctId': 'NCT04164251', 'briefTitle': 'Inpatient Screening Mammography for Non-adherent and High Risk Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Inpatient Screening Mammography for Non-adherent and High Risk Women', 'orgStudyIdInfo': {'id': 'NA_00079826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inpatient screening mammography for non-adherent and high risk', 'description': 'All non-adherent women were offered inpatient screening mammography during hospitalization', 'interventionNames': ['Other: Screening mammography']}], 'interventions': [{'name': 'Screening mammography', 'type': 'OTHER', 'description': 'The purpose of the study was to evaluate the feasibility of securing inpatient breast cancer screening mammograms for non-adherent hospitalized women prior to hospital discharge.', 'armGroupLabels': ['Inpatient screening mammography for non-adherent and high risk']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Waseem Khaliq, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maryland Cigarette Restitution Fund', 'class': 'OTHER_GOV'}, {'name': 'EQUIP (Excellence in Quality, Utilization of resources, Integration and Patient- centered Care)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}