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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive standard care

  • Discussion

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

  • Virtual Reality

    Procedure/Surgery

    Receive access to ViRA application

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Arm I (delayed-start intervention [ViRA application])Experimental treatment 4 interventions
Group B: Arm II (ViRA application)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Reach - acceptance of ViRA

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

Time frame
Baseline
3

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.

Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
4

Utilization of the PPCD ViRA

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

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

Secondary outcomes

1

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.

Time frame
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
2

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.

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

Psycho-oncology support

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator