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

Recruiting

• Conditions: Prostate Carcinoma

• Registration Number: NCT06535802
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model	Up to 4 months	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.
Acceptance of the iCCaRE ViRA	Baseline; follow-up interview 3-4 months post visit	Will be assessed by patient immediate reaction and patient delayed feedback.
Usability of the iCCaRE ViRA	Baseline; follow-up interview 3-4 months post visit	Will be assessed by patient immediate reaction and patient delayed feedback.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States