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
64Conditions
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 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.
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 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
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
Study Plan
Observational cohort I
Consumer advocates attend a focus group on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational cohort II
Clinicians complete interviews on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational cohort III
iCCaRE project representatives test the virtual health intervention, complete a survey, and attend a focus group on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
Observational cohort IV
Non iCCaRE affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study.
OTHER:
Non-Interventional StudyDescription:
Non-interventional study
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:
Non-Interventional StudyDescription:
Non-interventional study
Outcome Measures
Primary Outcome Measures
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot Assistant (ViRA) model
Acceptance of the iCCaRE Virtual Robot Assistant (ViRA)
Usability of the iCCaRE ViRA
Timeline
Last Updated
August 2, 2024Start Date
August 2, 2024Today
January 16, 2025Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
Lead Sponsor
Mayo Clinic
RECRUITING 
21 - 64 Years