iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men

NCT ID: NCT06535802

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2026-12-01

Brief Summary

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This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

Detailed Description

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PRIMARY OBJECTIVES:

I. 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.

II: Establish the acceptance and usability of the iCCaRE ViRA among 50 African American/Black men (AA/BM) at local Jacksonville sites.

OUTLINE: This is an observational study. Participants are assigned to 1 of 4 cohorts.

COHORT I: Consumer advocates attend a focus group on study.

COHORT II: Clinicians complete interviews on study.

COHORT III: CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.

COHORT IV: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Conditions

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Prostate Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational cohort I

Consumer advocates attend a focus group on study.

Focus group

Intervention Type OTHER

Attend a focus group session

Observational cohort II

Clinicians complete interviews on study.

Clinician Interviews

Intervention Type OTHER

Participate in clinician interviews

Observational cohort III

CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.

Focus group

Intervention Type OTHER

Attend a focus group session

Intervention testing

Intervention Type OTHER

Test the virtual health intervention

Survey

Intervention Type OTHER

Complete a follow-up survey

Observational cohort V

Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Survey

Intervention Type OTHER

Complete a follow-up survey

Follow-up Interview

Intervention Type OTHER

Participate in a follow-up interview

Virtual Health Intervention

Intervention Type OTHER

Participate in the virtual health intervention

Interventions

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Focus group

Attend a focus group session

Intervention Type OTHER

Clinician Interviews

Participate in clinician interviews

Intervention Type OTHER

Intervention testing

Test the virtual health intervention

Intervention Type OTHER

Survey

Complete a follow-up survey

Intervention Type OTHER

Follow-up Interview

Participate in a follow-up interview

Intervention Type OTHER

Virtual Health Intervention

Participate in the virtual health intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* AIM 1: iCCaRE Consortium consumer advocates
* Clinicians who are part of the Translational Research \& Clinical Intervention Services (TRaCIS)
* AIM 2 ALPHA TESTING: iCCaRE consumer advocates \[2 Community Advisory Board (CAB) and 1 non-CAB\]
* AIM 2 BETA TESTING-PATIENTS:

* An African American/Black male
* 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)
* Minimum age of 30 years old
* Consent to participating in the intervention

Exclusion Criteria

* AIM 2 BETA TESTING-PATIENTS:

* Patients who are not African American/Black males
* 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
* Older than 80 years old
* Are not willing to consent
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Folakemi T. Odedina, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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W81XWH2210968

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2024-05156

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC220501

Identifier Type: OTHER

Identifier Source: secondary_id

22-001412

Identifier Type: OTHER

Identifier Source: secondary_id

MC220501

Identifier Type: -

Identifier Source: org_study_id

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