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NCT Number: NCT06535802

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

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

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Folakemi T. Odedina, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Other

Attend a focus group session

Clinician Interviews

Other

Participate in clinician interviews

Intervention testing

Other

Test the virtual health intervention

Survey

Other

Complete a follow-up survey

Follow-up Interview

Other

Participate in a follow-up interview

Virtual Health Intervention

Other

Participate in the virtual health intervention

Primary outcomes

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

    Time frame: Up to 4 months

    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.

  2. Acceptance of the iCCaRE ViRA

    Time frame: Baseline; follow-up interview 3-4 months post visit

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

  3. Usability of the iCCaRE ViRA

    Time frame: Baseline; follow-up interview 3-4 months post visit

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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