A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men

NCT07126548 | Not Yet Recruiting

• 4 other identifiers: MC250501HT94252411104PC230672P1124-013879
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Reach - enrollment

  Reach of the point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) will be measured by the number of AA/BM who enroll in the study when offered.

  Baseline

• Reach - acceptance of ViRA

  Reach of the PPCD ViRA will be measured by the % of AA/BM who accept the ViRA when offered.

  Baseline

• Reach - initiation of ViRA

  Reach of the PPCD ViRA will be measured by the number of AA/BM who initiate the ViRA at the clinic vs. home vs. community setting.

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

• Utilization of the PPCD ViRA

  Will be measured by total # of AA/BM who used the Vira at least once a week.

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (3)

• Change in social determinants of health (SDOH) navigation

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

• Change in emotional support

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

• Psycho-oncology support

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Best Practice; Other: Discussion; Other: Survey Administration; Procedure: Virtual Reality

Arm II (ViRA application)

EXPERIMENTAL

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.

Other: Discussion; Other: Survey Administration; Procedure: Virtual Reality

Interventions

Discussion OTHER

Ancillary studies

Also known as: Discuss

Arm I (delayed-start intervention [ViRA application]); Arm II (ViRA application)

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

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

Survey Administration OTHER

Ancillary studies

Arm I (delayed-start intervention [ViRA application]); Arm II (ViRA application)

Virtual Reality PROCEDURE

Receive access to ViRA application

Also known as: VR

Arm I (delayed-start intervention [ViRA application]); Arm II (ViRA application)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

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)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Folakemi T. Odedina, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dee Glaser-Boivin

CONTACT

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

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Protocol indicated this being a two-arm randomized, single-blind clinical trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): September 2, 2029
• Study Completion (Estimated): September 2, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)