Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-31 @ 2:46 AM
Study NCT ID:
NCT05089903
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Outreach Among Primary Care Patients
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-24', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mammogram Positivity Rate', 'timeFrame': '3 months', 'description': 'Percent of mammograms that have positive results'}, {'measure': 'Mammogram Completion by Age Groups', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram by age groups'}, {'measure': 'Mammogram Completion by Race/Ethnicity', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram by race/ethnicity'}, {'measure': 'Mammogram Completion by Insurance Type', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram by insurance type'}, {'measure': 'Mammogram Completion by Median Household Income by Zip Code', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram by Median Household Income by zip code'}, {'measure': 'Positive Mammograms Resulting in Subsequent Care', 'timeFrame': '3 months', 'description': 'Percent of patients with a positive mammogram that receive subsequent care'}, {'measure': 'Mammogram Completion by Electronic Patient Portal Status', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram by electronic patient portal status'}], 'primaryOutcomes': [{'measure': 'Mammogram Completion in 3 months', 'timeFrame': '3 months', 'description': 'Percent of patients that complete a mammogram'}], 'secondaryOutcomes': [{'measure': 'Mammogram Completion in 6 months', 'timeFrame': '6 months', 'description': 'Percent of patients that complete a mammogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mammography', 'Preventive Screening', 'Population Health'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38709509', 'type': 'DERIVED', 'citation': 'Mehta SJ, Rhodes C, Linn KA, Reitz C, McDonald C, Okorie E, Williams K, Resnick D, Arostegui A, McAuliffe T, Wollack C, Snider CK, Peifer MK, Weinstein SP. Behavioral Interventions to Improve Breast Cancer Screening Outreach: Two Randomized Clinical Trials. JAMA Intern Med. 2024 Jul 1;184(7):761-768. doi: 10.1001/jamainternmed.2024.0495.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.', 'detailedDescription': 'While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women ages 40-74\n2. Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years\n3. Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)\n\nExclusion Criteria:\n\n1. Currently scheduled for a mammogram\n2. History of bilateral mastectomy'}, 'identificationModule': {'nctId': 'NCT05089903', 'briefTitle': 'Breast Cancer Outreach Among Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Breast Cancer Outreach Among Primary Care Patients', 'orgStudyIdInfo': {'id': 'UPCC 15121'}, 'secondaryIdInfos': [{'id': '849863', 'type': 'OTHER', 'domain': 'UPenn IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Order', 'interventionNames': ['Behavioral: No Bulk Order']}, {'type': 'EXPERIMENTAL', 'label': 'No Order + Text (NO+T)', 'interventionNames': ['Behavioral: Texting', 'Behavioral: No Bulk Order']}, {'type': 'EXPERIMENTAL', 'label': 'Bulk Order (BO)', 'interventionNames': ['Behavioral: Bulk Order']}, {'type': 'EXPERIMENTAL', 'label': 'Bulk Order + Text (BO+T)', 'interventionNames': ['Behavioral: Bulk Order', 'Behavioral: Texting']}, {'type': 'EXPERIMENTAL', 'label': 'Clinician Endorsement (CE)', 'interventionNames': ['Behavioral: Clinician Endorsement']}, {'type': 'EXPERIMENTAL', 'label': 'Clinician Endorsement + Text (CE+T)', 'interventionNames': ['Behavioral: Texting', 'Behavioral: Clinician Endorsement']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Messaging (SM)', 'interventionNames': ['Behavioral: Standard Endorsement']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Messaging (SM+T)', 'interventionNames': ['Behavioral: Texting', 'Behavioral: Standard Endorsement']}], 'interventions': [{'name': 'Bulk Order', 'type': 'BEHAVIORAL', 'description': 'A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.', 'armGroupLabels': ['Bulk Order (BO)', 'Bulk Order + Text (BO+T)']}, {'name': 'Texting', 'type': 'BEHAVIORAL', 'description': 'In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.', 'armGroupLabels': ['Bulk Order + Text (BO+T)', 'Clinician Endorsement + Text (CE+T)', 'No Order + Text (NO+T)', 'Standard Messaging (SM+T)']}, {'name': 'Clinician Endorsement', 'type': 'BEHAVIORAL', 'description': "Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.", 'armGroupLabels': ['Clinician Endorsement (CE)', 'Clinician Endorsement + Text (CE+T)']}, {'name': 'No Bulk Order', 'type': 'BEHAVIORAL', 'description': "The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.", 'armGroupLabels': ['No Order', 'No Order + Text (NO+T)']}, {'name': 'Standard Endorsement', 'type': 'BEHAVIORAL', 'description': "Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.", 'armGroupLabels': ['Standard Messaging (SM)', 'Standard Messaging (SM+T)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Shivan Mehta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shivan Mehta', 'investigatorAffiliation': 'Abramson Cancer Center at Penn Medicine'}}}}