About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Do not speak or understand English
Unable to read or write
Trial design
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive standard care
Discussion
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Virtual Reality
Procedure/SurgeryReceive access to ViRA application
Treatment groups
Trial outcomes
Primary outcomes
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.
Reach - acceptance of ViRA
Reach of the PPCD ViRA will be measured by the % of AA/BM who accept the ViRA when offered.
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.
Utilization of the PPCD ViRA
Will be measured by total # of AA/BM who used the Vira at least once a week.
Secondary outcomes
Change in social determinants of health (SDOH) navigation
Will be assessed by participant self-reported ability to find help for daily needs such as food, housing, reliable transportation for medical appointments.
Change in emotional support
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.
Psycho-oncology support
Assessed by providers using National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2024 Distress Management.
Sponsors and contacts
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Mayo Clinic
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator