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

Mayo Clinic

Status: Begins enrollment this month

Conditions: Prostate Carcinoma

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

Study type: Interventional

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

Identifiers

NCT07126548

HT94252411104 (Other Grant/Funding Number)

24-013879 (Other Identifier)

NCI-2025-04864 (Registry Identifier)

MC250501 (Other Identifier)

PC230672P11 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the effectiveness of the PPCD ViRA (i) on the delivery of PPCD support in a clinic setting, at home and community setting; and (ii) in providing social determinants of health (SDOH) navigation, emotional support and psycho-oncology support for African American/Black men (AA/BM) newly diagnosed with prostate cancer (CaP).

II. Assess the effectiveness of the PPCD ViRA in reducing emotional distress and improving other patient reported outcomes (PROs).

III. Using a mixed-method approach, explore the factors that uniquely influence the implementation of the PPCD ViRA in a clinic setting, at home and community setting.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (DELAYED-START INTERVENTION): Patients receive standard care and then receive access to the ViRA application (app) (on a [virtual reality] 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.

ARM II (EARLY START INTERVENTION): 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.

After completion of study intervention, patients are followed up at 1, 3, 6, 9 and 12 months.

Enrollment: 200 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Procedure: Virtual Reality

Other: Best Practice

Other: Discussion

Arm II (ViRA application)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Procedure: Virtual Reality

Other: Discussion