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

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Other: Non-Interventional Study

• 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 at a urology clinic among 50 Black men (BM).

OUTLINE: This is an observational study. Participants are assigned to 1 of 5 cohorts.

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

COHORT II: Clinicians complete interviews on study.

COHORT III: iCCaRE project representatives test the virtual health intervention, complete a survey, and attend a focus group on study.

COHORT IV: Non iCCaRE affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study.

COHORT V: 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
• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• AIM 1: iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research & Clinical Intervention Services core, and non-iCCaRE affiliated member.

• AIM 2 ALPHA TESTING: 1 representative from each of the other iCCaRE five projects and six cores/services and 1 non iCCaRE affiliated member

• AIM 2 BETA TESTING-PATIENTS:

  • A Black male
  • A patient who has been diagnosed with prostate cancer in Florida
  • Have an abnormal PSA and/or DRE lab value within the previous 6 months
  • Minimum age of 30 yrs
  • Consent to participating in the intervention

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Exclusion Criteria

• AIM 2 BETA TESTING-PATIENTS:

  • Patients who are not Black males
  • Not patients at a urology clinic
  • Have normal PSA and/or DRE lab values within the previous 6 months
  • Older than 80 yrs
  • Are not willing to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational cohort II	Non-Interventional Study	Clinicians complete interviews on study.
Observational cohort III	Non-Interventional Study	iCCaRE project representatives test the virtual health intervention, complete a survey, and attend a focus group on study.
Observational cohort I	Non-Interventional Study	Consumer advocates attend a focus group on study.
Observational cohort IV	Non-Interventional Study	Non iCCaRE affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study.
Observational cohort V	Non-Interventional Study	Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Primary Outcome Measures

Name	Time	Method
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.
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot 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. 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 Virtual Robot Assistant (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