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

NCT06535802 | Recruiting

• 4 other identifiers: MC220501W81XWH2210968NCI-2024-0515622-001412
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model

  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. 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.

  Up to 4 months

• Acceptance of the iCCaRE ViRA

  Will be assessed by patient immediate reaction and patient delayed feedback.

  Baseline; follow-up interview 3-4 months post visit

• Usability of the iCCaRE ViRA

  Will be assessed by patient immediate reaction and patient delayed feedback.

  Baseline; follow-up interview 3-4 months post visit

Study Arms (4)

Observational cohort I

Consumer advocates attend a focus group on study.

Other: Focus group

Observational cohort II

Clinicians complete interviews on study.

Other: Clinician Interviews

Observational cohort III

CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.

Other: Focus group; Other: Intervention testing; Other: 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: Survey; Other: Follow-up Interview; Other: Virtual Health Intervention

Interventions

Focus group OTHER

Attend a focus group session

Observational cohort I; Observational cohort III

Clinician Interviews OTHER

Participate in clinician interviews

Observational cohort II

Intervention testing OTHER

Test the virtual health intervention

Observational cohort III

Survey OTHER

Complete a follow-up survey

Observational cohort III; Observational cohort V

Follow-up Interview OTHER

Participate in a follow-up interview

Observational cohort V

Virtual Health Intervention OTHER

Participate in the virtual health intervention

Observational cohort V

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research \& Clinical Intervention Services. Community Advisory Board (CAB) and non-CAB iCCaRE consumer advocates. Patients with an abnormal PSA and/or DRE diagnosed with prostate cancer in the state of Florida.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Focus Groups; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Folakemi T. Odedina, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)