Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-16 @ 9:48 PM
Study NCT ID:
NCT06535802
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
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': 'D017144', 'term': 'Focus Groups'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model', 'timeFrame': 'Up to 4 months', 'description': "Will be assessed by the length of time needed to create the model. PPCD iCCaRE ViRA model development will be guided by the Translational Research \\& Clinical Intervention Services (TRaCIS) and Digital Health \\& Human Services (DHHS) core sections of the Inclusive Cancer Care Research Equity (iCCaRE) Consortium. The consortium's scientific team and Community Advisory Board (CAB) will participate in making decisions about how to proceed with the development of the ViRA Intervention and Communication Strategy Plan (ICoSP). This application (app) will be evaluated in Outcomes 2 and 3. The PPCD iCCaRE ViRA app will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research."}, {'measure': 'Acceptance of the iCCaRE ViRA', 'timeFrame': 'Baseline; follow-up interview 3-4 months post visit', 'description': 'Will be assessed by patient immediate reaction and patient delayed feedback.'}, {'measure': 'Usability of the iCCaRE ViRA', 'timeFrame': 'Baseline; follow-up interview 3-4 months post visit', 'description': 'Will be assessed by patient immediate reaction and patient delayed feedback.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.\n\nII: Establish the acceptance and usability of the iCCaRE ViRA among 50 African American/Black men (AA/BM) at local Jacksonville sites.\n\nOUTLINE: This is an observational study. Participants are assigned to 1 of 4 cohorts.\n\nCOHORT I: Consumer advocates attend a focus group on study.\n\nCOHORT II: Clinicians complete interviews on study.\n\nCOHORT III: CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.\n\nCOHORT IV: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research \\& Clinical Intervention Services. Community Advisory Board (CAB) and non-CAB iCCaRE consumer advocates. Patients with an abnormal PSA and/or DRE diagnosed with prostate cancer in the state of Florida.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AIM 1: iCCaRE Consortium consumer advocates\n* Clinicians who are part of the Translational Research \\& Clinical Intervention Services (TRaCIS)\n* AIM 2 ALPHA TESTING: iCCaRE consumer advocates \\[2 Community Advisory Board (CAB) and 1 non-CAB\\]\n* AIM 2 BETA TESTING-PATIENTS:\n\n * An African American/Black male\n * A patient who has been diagnosed with prostate cancer in Florida at any time in their life, and/or within the previous 6 months has had an abnormal Prostate-Specific Antigen (PSA) lab value and/or Digital Rectal Examination (DRE)\n * Minimum age of 30 years old\n * Consent to participating in the intervention\n\nExclusion Criteria:\n\n* AIM 2 BETA TESTING-PATIENTS:\n\n * Patients who are not African American/Black males\n * Patients not diagnosed with prostate cancer in Florida at any time in their life, or within the previous 6 months has not had a normal PSA lab value and/or DRE\n * Older than 80 years old\n * Are not willing to consent'}, 'identificationModule': {'nctId': 'NCT06535802', 'briefTitle': 'iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men', 'orgStudyIdInfo': {'id': 'MC220501'}, 'secondaryIdInfos': [{'id': 'NCI-2024-05156', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'MC220501', 'type': 'OTHER', 'domain': 'Mayo Clinic in Florida'}, {'id': '22-001412', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational cohort I', 'description': 'Consumer advocates attend a focus group on study.', 'interventionNames': ['Other: Focus group']}, {'label': 'Observational cohort II', 'description': 'Clinicians complete interviews on study.', 'interventionNames': ['Other: Clinician Interviews']}, {'label': 'Observational cohort III', 'description': 'CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.', 'interventionNames': ['Other: Focus group', 'Other: Intervention testing', 'Other: Survey']}, {'label': 'Observational cohort V', 'description': 'Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.', 'interventionNames': ['Other: Survey', 'Other: Follow-up Interview', 'Other: Virtual Health Intervention']}], 'interventions': [{'name': 'Focus group', 'type': 'OTHER', 'description': 'Attend a focus group session', 'armGroupLabels': ['Observational cohort I', 'Observational cohort III']}, {'name': 'Clinician Interviews', 'type': 'OTHER', 'description': 'Participate in clinician interviews', 'armGroupLabels': ['Observational cohort II']}, {'name': 'Intervention testing', 'type': 'OTHER', 'description': 'Test the virtual health intervention', 'armGroupLabels': ['Observational cohort III']}, {'name': 'Survey', 'type': 'OTHER', 'description': 'Complete a follow-up survey', 'armGroupLabels': ['Observational cohort III', 'Observational cohort V']}, {'name': 'Follow-up Interview', 'type': 'OTHER', 'description': 'Participate in a follow-up interview', 'armGroupLabels': ['Observational cohort V']}, {'name': 'Virtual Health Intervention', 'type': 'OTHER', 'description': 'Participate in the virtual health intervention', 'armGroupLabels': ['Observational cohort V']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Folakemi T. Odedina, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Folakemi T. Odedina, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}