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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06535802
Enrollment
53
Registered
2024-08-02
Start date
2023-11-20
Completion date
2026-12-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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.

Interventions

OTHERFocus group

Attend a focus group session

OTHERClinician Interviews

Participate in clinician interviews

OTHERIntervention testing

Test the virtual health intervention

OTHERSurvey

Complete a follow-up survey

Participate in a follow-up interview

OTHERVirtual Health Intervention

Participate in the virtual health intervention

Sponsors

Mayo Clinic
Lead SponsorOTHER
Congressionally Directed Medical Research Programs
CollaboratorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) modelUp to 4 monthsWill 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 ViRABaseline; follow-up interview 3-4 months post visitWill be assessed by patient immediate reaction and patient delayed feedback.
Usability of the iCCaRE ViRABaseline; follow-up interview 3-4 months post visitWill be assessed by patient immediate reaction and patient delayed feedback.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFolakemi T. Odedina, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026