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Virtual Reality Assistant for Prostate Cancer Support in Black Men

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What is being tested

Best Practice

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Other
Procedure
Who is being recruted

Prostate Carcinoma

+6 Eligibility Criteria

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How is the trial designed

Supportive Care Study

Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactDee Glaser-Boivin
Last updated: October 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to evaluate a new virtual reality tool called PPCD ViRA that supports African American/Black men who have recently been diagnosed with prostate cancer. The study is focused on seeing how well this tool can provide emotional support, help with navigating health-related social challenges, and offer psycho-oncology support. The main goal is to find out if using this virtual reality assistant can reduce emotional distress and improve the well-being of these patients. This research is important because it seeks to address the specific needs of Black men with prostate cancer, potentially offering more personalized and effective support. Participants in the study are divided into two groups. One group starts using the ViRA app immediately, while the other starts after a three-month delay. The ViRA app can be accessed through various devices like a VR headset, smartphone, iPad, or computer. It uses artificial intelligence to provide tailored virtual reality experiences that are culturally relevant and facilitated by digital characters like a prostate cancer survivor or a doctor. Throughout the study, participants' emotional well-being and other outcomes are monitored at several intervals to assess the effectiveness of the intervention. This trial does not mention specific risks, but it aims to enhance the support system for those dealing with a new cancer diagnosis.

Official TitleA 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 
Principal SponsorMayo Clinic
Study ContactDee Glaser-Boivin
Last updated: October 27, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Prostate Carcinoma
Criteria
4 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
Do not speak or understand English
Unable to read or write

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives

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.

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

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.

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

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

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.

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Mayo Clinic in FloridaJacksonville, United StatesSee the location
Recruiting soonOne Study Center