Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 12:32 PM
Study NCT ID:
NCT05665660
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening
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': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Women randomized to receive CARE who have not received a mammography at 3 months will be offered CARE+COACH to facilitate completion of their screening and contacted at 4 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mammography uptake', 'timeFrame': '2 months', 'description': 'Mammography uptake within 2 months of referral'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mammography', 'cancer screening'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referral for screening mammography from a Whiteriver Indian Health Service provider\n* Self-identify as American Indian or Alaska Native (AIAN)\n* Female\n* Live on within 60 miles of the Fort Apache Indian Reservation\n\nExclusion Criteria:\n\n* Women who have received a mammogram within the prior 12 months\n* Women with a personal history of breast cancer\n* Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)\n* Unwilling to be randomized'}, 'identificationModule': {'nctId': 'NCT05665660', 'briefTitle': 'Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Developing and Evaluating Scalable and Culturally Relevant Interventions to Improve Breast Cancer Screening Among White Mountain Apache Women', 'orgStudyIdInfo': {'id': 'IRB00022667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARE - Intervention arm for mammography education', 'description': 'CARE is a culturally tailored mammography education module.', 'interventionNames': ['Behavioral: CARE']}, {'type': 'EXPERIMENTAL', 'label': 'CARE + COACH - Intervention arm for mammography education + a patient navigator', 'description': "CARE + COACH is the CARE education module in addition to a COACH, which is access to an Apache paraprofessional women's health coach. The Coach functions like a patient navigator.", 'interventionNames': ['Behavioral: CARE + COACH']}], 'interventions': [{'name': 'CARE', 'type': 'BEHAVIORAL', 'description': 'CARE is a culturally tailored mammography education module.', 'armGroupLabels': ['CARE - Intervention arm for mammography education']}, {'name': 'CARE + COACH', 'type': 'BEHAVIORAL', 'description': "CARE + COACH is a culturally tailored mammography education module + access to an Apache paraprofessional women's health coach who functions as a patient navigator", 'armGroupLabels': ['CARE + COACH - Intervention arm for mammography education + a patient navigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85941', 'city': 'Whiteriver', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Indigenous Health', 'geoPoint': {'lat': 33.83699, 'lon': -109.96427}}], 'overallOfficials': [{'name': 'Allison Barlow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Native American Research Center for Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}