iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
Status
RECRUITING
Phase
Age
All Ages
Enrollments
53Conditions
Prostate CarcinomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Folakemi T. Odedina, PhD
Eligibility Criteria
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 Plan
Observational cohort I
Consumer advocates attend a focus group on study.
OTHER:
Focus groupDescription:
Attend a focus group session
Observational cohort II
Clinicians complete interviews on study.
OTHER:
Clinician InterviewsDescription:
Participate in clinician interviews
Observational cohort III
CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
OTHER:
Focus groupDescription:
Attend a focus group sessionOTHER:
Intervention testingDescription:
Test the virtual health interventionOTHER:
SurveyDescription:
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.
OTHER:
SurveyDescription:
Complete a follow-up surveyOTHER:
Follow-up InterviewDescription:
Participate in a follow-up interviewOTHER:
Virtual Health InterventionDescription:
Participate in the virtual health intervention
Outcome Measures
Primary Outcome Measures
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model
Acceptance of the iCCaRE ViRA
Usability of the iCCaRE ViRA
Timeline
Last Updated
August 7, 2025Start Date
August 2, 2024Today
December 7, 2025Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
Lead Sponsor
Mayo Clinic
RECRUITING 
≥ 18 Years