Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT06205394
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-14', 'size': 212288, 'label': 'Informed Consent Form: Patients', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-10T10:24', 'hasProtocol': False}, {'date': '2023-04-14', 'size': 211387, 'label': 'Informed Consent Form: Clincians', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-10T10:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivor participant feedback, opinions, and preferences for breast cancer care', 'timeFrame': 'At completion of study up to 2 years', 'description': 'Data is verbally reported and collected in focus groups'}, {'measure': 'Clinician participant reports of experiences, opinions, and knowledge of caring for LGBTQ+ people', 'timeFrame': 'At completion of study up to 2 years', 'description': 'Data is verbally reported and collected in interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority (INTENDED for SGM) in identifying the patient, support person and provider barriers to quality care in SGM breast/chest cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the important ways the iCanDecide breast cancer decision aid needs revised for SGM people, and how best to integrate a culturally-relevant tool into clinical practice.\n\nOUTLINE: This is an observational study.\n\nAIM 1: Interview transcripts from SANGRIA study utilized to explore the values, preferences and key considerations for breast cancer treatment decision making in SGM individuals.\n\nAIM 2: Patients are assigned to 1 of 2 groups.\n\nGROUP 1: Cancer survivors participate in a focus group on study.\n\nGROUP 2: Breast cancer clinicians undergo a semi-structured interview on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer survivors that self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender and breast oncology clinicians recruited through Ohio State University Comprehensive Cancer Center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SURVIVORS:\n\n * Self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender\n * Must be a breast cancer survivor, in active treatment or completed active treatment in the last 10 years (not including hormone therapy)\n * Be over age 18\n * English-speaking\n * Received care in the US\n\nBREAST ONCOLOGY CLINICIANS: Physicians, advanced practice providers, nurses, psychologists and social workers will be eligible if they:\n\n* Provide care and/or surgical decision support to individuals diagnosed with early stage breast cancer in the US\n* Are English-speaking'}, 'identificationModule': {'nctId': 'NCT06205394', 'briefTitle': 'Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors (Intended for SGM)', 'orgStudyIdInfo': {'id': 'OSU-22123'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00667', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'OSU-22123', 'type': 'OTHER', 'domain': 'Ohio State University Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'GROUP 1 (focus group)', 'description': 'Cancer survivors participate in a focus group on study.', 'interventionNames': ['Other: Non-Interventional Study']}, {'label': 'GROUP 2 (interview)', 'description': 'Breast cancer clinicians undergo a semi-structured interview on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['GROUP 1 (focus group)', 'GROUP 2 (interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Elizabeth K Arthur, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth Arthur', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}