Prostate Carcinoma
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERBest Practice
Receive standard care
OTHERDiscussion
Ancillary studies
OTHERSurvey Administration
Ancillary studies
PROCEDUREVirtual Reality
Receive access to ViRA application
Sponsors
Mayo Clinic
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Protocol indicated this being a two-arm randomized, single-blind clinical trial.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach - enrollment | 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. |
| Reach - acceptance of ViRA | Baseline | Reach of the PPCD ViRA will be measured by the % of AA/BM who accept the ViRA when offered. |
| Reach - initiation of ViRA | 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. |
| Utilization of the PPCD ViRA | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in social determinants of health (SDOH) navigation | 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. |
| Change in emotional support | 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. |
| Psycho-oncology support | 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. |
Countries
United States
Contacts
CONTACTDee Glaser-Boivin
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORFolakemi T. Odedina, PhD
Mayo Clinic
Outcome results
None listed