iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Focus group, Clinician Interviews, Intervention testing, Survey.
- Who it may be relevant to
- Registry conditions: Prostate Carcinoma. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Focus group
Attend a focus group session - Other Clinician Interviews
Participate in clinician interviews - Other Intervention testing
Test the virtual health intervention - Other Survey
Complete a follow-up survey - Other Follow-up Interview
Participate in a follow-up interview - Other Virtual Health Intervention
Participate in the virtual health intervention
Primary outcome measures
- Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model [Time frame: Up to 4 months]
- Acceptance of the iCCaRE ViRA [Time frame: Baseline; follow-up interview 3-4 months post visit]
- Usability of the iCCaRE ViRA [Time frame: Baseline; follow-up interview 3-4 months post visit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06535802 · MC220501 · W81XWH2210968 · NCI-2024-05156 · MC220501 · 22-001412