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NCT Number: NCT07126548

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Best Practice

Other

Receive standard care

Other names: standard of care, standard therapy

Discussion

Other

Ancillary studies

Other names: Discuss

Survey Administration

Other

Ancillary studies

Virtual Reality

Procedure

Receive access to ViRA application

Other names: VR

Primary outcomes

  1. Reach - enrollment

    Time frame: Baseline

    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.

  2. Reach - acceptance of ViRA

    Time frame: Baseline

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

  3. Reach - initiation of ViRA

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

    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.

  4. Utilization of the PPCD ViRA

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

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

Secondary outcomes

  1. Change in social determinants of health (SDOH) navigation

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

    Will be assessed by participant self-reported ability to find help for daily needs such as food, housing, reliable transportation for medical appointments.

  2. Change in emotional support

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

    Will be measured using the Positive Affect and Negative Affect Schedule-Expanded Form (PANAS-X), a 60-item questionnaire designed to measure a person's emotional state, both positive and negative, during a specific time frame. Participants rate how they feel on a 5-point Likert scale for each item (e.g., "right now" or "in general"). For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.

  3. Psycho-oncology support

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

    Assessed by providers using National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2024 Distress Management.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Dee Glaser-Boivin

CONTACT

[email protected]

904-953-4759

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

A Pragmatic Clinical Trial to Evaluate the Effect of a Point of Prostate Cancer Diagnosis (PPCD) Virtual Reality Assistant (ViRA) in Supporting Newly Diagnosed Black Men

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 17, 2025
Registry last updated
Apr 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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