Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT07105020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
iCCARE Project #4: Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men Diagnosed With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial is aimed to better understand the impact of migration history on the quality of life of Black immigrant CaP survivors (both SSAI and CI). We will illuminate the full range of racial, social, environmental, behavioral, and structural factors associated with the Black immigrant experience in the US using a SDOH model.', 'detailedDescription': 'Primary Objective:'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be male adults (≥18 years old)\n* Self-identify as CI and SSAI\n* Self-identify as Black or African American\n* Have been diagnosed with CaP within the last 10 years\n* Have a U.S. address\n* Can read and write in English\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT07105020', 'briefTitle': 'iCCARE Project #4: Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men Diagnosed With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'iCCARE Project #4: Grounded Theory Study of the Social Determinants of Migrant Health Factors Impacting Prostate Cancer Care and Survivorship Among Sub-Saharan African and Caribbean Immigrant Men Diagnosed With Prostate Cancer', 'orgStudyIdInfo': {'id': '2025-0229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theory Study of the Black Immigrant using a SDOH Model', 'description': 'Participants will be recruited by utilizing the MD Anderson Cancer Registry', 'interventionNames': ['Behavioral: Interviews']}], 'interventions': [{'name': 'Interviews', 'type': 'BEHAVIORAL', 'description': 'Interviews will be conducted in person, over the phone, or via Zoom.', 'armGroupLabels': ['Theory Study of the Black Immigrant using a SDOH Model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Lorna McNeill, MPH,PHD', 'role': 'CONTACT', 'email': 'lmcneill@mdanderson.org', 'phone': '(713) 563-1103'}, {'name': 'Lorna McNeill, MPH,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Lorna McNeill, MPH,PHD', 'role': 'CONTACT', 'email': 'lmcneill@mdanderson.org', 'phone': '(713) 563-1103'}], 'overallOfficials': [{'name': 'Lorna McNeill, MPH,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}