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Not yet recruiting Not applicable NCT07126548

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

No applicable phase (e.g. observational)
Conditions: Prostate Carcinoma

Sponsor: Mayo Clinic

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Best Practice
OTHER
Discussion
OTHER
Survey Administration
OTHER
Virtual Reality
PROCEDURE
Locations 1
United States (1)
Mayo Clinic in Florida
Jacksonville , Florida
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male only
Healthy volunteers
No
Start date
01.06.2027
Completion date
02.09.2029
Registry ID
NCT07126548
Source
clinicaltrials.gov
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