Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-26 @ 5:51 PM
Study NCT ID:
NCT06112795
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mammography screening behavior', 'timeFrame': 'Baseline (at enrollment)', 'description': 'Mammography screening behavior will be measured using two self-reported items: 1) history of ever having a mammogram, with a yes/no response and 2) history of last (most recent) mammogram" with the following response options: within the past year; at least 1, but less than 2 years ago; at least 2, but less than 5 years ago; 5 or more years ago; don\'t remember. Using these two items, a new variable of mammography screening behavior will be created, defined as the number of prior mammograms, categorizing responses as 0, 1 to 2, and 2+.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Breast Cancer', 'Breast Cancer Female']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Examine the association between perceived risk and mammography screening behavior and differences in perceived risk by patient characteristics in Hispanic women screened at Mountain Park Health Center (MPHC).\n\nII. Characterize attitudes, beliefs, and barriers towards mammography screening and cultural acceptability of BRCA models in community settings using focus group and interview data from under- and uninsured Hispanic women in Maricopa County.\n\nOUTLINE: This is an observational study.\n\nParticipants attend an interview or participate in a focus group on study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Under and uninsured Hispanic women living in Maricopa county', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AIM 1:\n\n * Completed a baseline survey for the Latinas Learning about Density (LLEAD) study\n * Self-identify as Hispanic\n * Between 40-65 years of age\n* AIM 2:\n\n * Between the ages of 45 and 65\n * Self-identify as Hispanic\n * Current residence in Maricopa County\n * Be under- (e.g. Arizona Health Care Cost Containment System) or uninsured at the time of enrollment\n * Can read and speak English or Spanish well enough to understand and complete the informed consent process and take part in either a focus group or individual interview\n\nExclusion Criteria:\n\n* AIM I:\n\n * Women with a history of breast cancer\n* AIM 2:\n\n * Women with a history of breast cancer'}, 'identificationModule': {'nctId': 'NCT06112795', 'briefTitle': 'Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County', 'orgStudyIdInfo': {'id': '22-001884'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00465', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '22-001884', 'type': 'OTHER', 'domain': 'Mayo Clinic in Arizona'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Participants attend an interview or participate in a focus group on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Jessica D. Austin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}