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

Mayo Clinic

Status: Enrolling

Conditions: Prostate Carcinoma

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

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06535802

MC220501 (Other Identifier)

22-001412 (Other Identifier)

NCI-2024-05156 (Registry Identifier)

W81XWH2210968 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

53 participants in 4 patient groups

Observational cohort I

Description:

Consumer advocates attend a focus group on study.

Treatment:

Other: Focus group

Observational cohort II

Description:

Clinicians complete interviews on study.

Treatment:

Other: Clinician Interviews

Observational cohort III

Description:

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

Treatment:

Other: Focus group

Other: Survey

Other: Intervention testing

Observational cohort V

Description:

Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Treatment:

Other: Follow-up Interview

Other: Survey

Other: Virtual Health Intervention