Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-29 @ 8:31 PM
Study NCT ID:
NCT06957535
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-led Navigation to Address Disparities in Mammography Among Native American 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with mammography', 'timeFrame': '3 months post baseline', 'description': 'Mammography uptake within 3 months of referral'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Self-identify as female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as American Indian or Alaska Native (AIAN)\n* Identify as Female\n* Are 40-74 years of age\n* Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)\n* Live within 80 miles of CCHFC\n* Have not received a mammogram within the prior 12 months\n* Do not have a personal history of breast cancer\n* Are not planning to move in the next 6 months\n* Willing to be randomized\n\nExclusion Criteria:\n\n* Do not self-identify as American Indian or Alaska Native (AIAN)\n* Do not identify as Female\n* Are not 40-74 years of age\n* Are not a registered patient at CCHCF\n* Do not live within 80 miles of CCHCF\n* Have received a mammogram within the prior 12 months\n* Have a personal history of breast cancer\n* Are planning to move in the next 6 months\n* Unwilling to be randomized'}, 'identificationModule': {'nctId': 'NCT06957535', 'briefTitle': 'Community-led Navigation to Address Disparities in Mammography Among Native American Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Community-led Navigation to Address Disparities in Mammography Among Native American Women', 'orgStudyIdInfo': {'id': 'IRB00031873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TEAM', 'description': 'TEAM (Tablet-based Education to improve the Acceptance of Mammography)', 'interventionNames': ['Behavioral: TEAM']}, {'type': 'EXPERIMENTAL', 'label': 'TEAM + Navigation', 'description': 'TEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator)', 'interventionNames': ['Behavioral: Navigation', 'Behavioral: TEAM']}], 'interventions': [{'name': 'Navigation', 'type': 'BEHAVIORAL', 'description': 'Navigation is provision of 1:1 support from a Diné peer-navigator', 'armGroupLabels': ['TEAM + Navigation']}, {'name': 'TEAM', 'type': 'BEHAVIORAL', 'description': 'TEAM encompasses culturally tailored mammography education modules', 'armGroupLabels': ['TEAM', 'TEAM + Navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86503', 'city': 'Chinle', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen Mitchell, MS', 'role': 'CONTACT', 'phone': '928-674-5051'}], 'facility': 'Navajo Nation Center for Indigenous Health', 'geoPoint': {'lat': 36.15445, 'lon': -109.55261}}], 'centralContacts': [{'name': 'Katie Nelson, PhD', 'role': 'CONTACT', 'email': 'knelso46@jhmi.edu', 'phone': '410-955-6931'}], 'overallOfficials': [{'name': 'Katie Nelson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}