Recruiting

ViRA

Sponsor:

Mayo Clinic

Code:

NCT07126548

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Discussion

Survey Administration

Virtual Reality

Study Details

Brief summary:

This clinical trial tests how well a point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) intervention works in supporting Black men with newly diagnosed prostate cancer. Cancer is the second leading cause of death for African American/Black men, with prostate cancer leading in estimated new cancer cases and second in estimated new cancer deaths. Over 40,000 African American/Black men are diagnosed with prostate cancer annually, with 1 in 6 lifetime probability of developing prostate cancer compared to 1 in 8 probability in White men. The PPCD ViRA provides psycho-oncology support, social determinants of health navigation and emotional support for ethnically diverse African American/Black men newly diagnosed with prostate cancer using artificial intelligence and augmented reality. Using PPCD ViRA may close the prostate cancer care gap for African American/Black men across the cancer continuum and provide emotional, educational, and resource needs of this population when they are visiting a doctor about their prostate health or prostate cancer.

Conditions

Prostate Carcinoma

Study ID

NCT07126548

Start date

Apr 24, 2026

Status verified date

Sep, 2026

Completion date

Sep 2, 2029

Anticipated

Primary completion date

Sep 2, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • African American/Black male
  • Diagnosed with CaP within two months
  • Be a patient at a participating clinic or affiliates with one of our community sites
  • Consent to participating in the study

Exclusion Criteria:

  • Do not speak or understand English
  • Unable to read or write

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (delayed-start intervention [ViRA application])

Patients receive standard care and then receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) 3 months later on study.

experimental: Arm II (ViRA application)

Patients receive access to the ViRA app (on a VR headset, smartphone, iPAD or computer) and are presented with short screening questions, which an AI engine uses to recommend personalized and culturally tailored VR ready CaP interventions facilitated by a digital human character (CaP survivor, physician, or a psycho-oncologist) on study.

Interventions

Best Practice

Receive standard care

Discussion

Ancillary studies

Survey Administration

Ancillary studies

Virtual Reality

Receive access to ViRA application

Primary outcome measure

  • Reach - enrollment [ Time Frame: Baseline ]
  • Reach - acceptance of ViRA [ Time Frame: Baseline ]
  • Reach - initiation of ViRA [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months ]
  • Utilization of the PPCD ViRA [ Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months ]

Central Contacts and Locations

Central contacts

Dee Glaser-Boivin

904-953-4759GlaserBoivin.Denielle@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Dee Glaser-Boivin

904-953-4759GlaserBoivin.Denielle@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Folakemi T. Odedina, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.