A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Discussion, Survey Administration, Virtual Reality.
- Who it may be relevant to
- Registry conditions: Prostate Carcinoma. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A 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
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.
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
- Other Best Practice
Receive standard care - Other Discussion
Ancillary studies - Other Survey Administration
Ancillary studies - Procedure Virtual Reality
Receive access to ViRA application
Primary outcome measures
- Reach - enrollment [Time frame: Baseline]
- Reach - acceptance of ViRA [Time frame: Baseline]
- Reach - initiation of ViRA [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
- Utilization of the PPCD ViRA [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
Secondary outcome measures (3)
- Change in social determinants of health (SDOH) navigation [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
- Change in emotional support [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
- Psycho-oncology support [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT07126548 · MC250501 · HT94252411104 · PC230672P11 · 24-013879