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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reach - enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Protocol indicated this being a two-arm randomized, single-blind clinical trial.
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Do not speak or understand English
- •Unable to read or write
研究组 & 干预措施
Arm I (delayed-start intervention [ViRA application])
Patients receive standard care and then 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) 3 months later on study.
干预措施: Best Practice (Other)
Arm I (delayed-start intervention [ViRA application])
Patients receive standard care and then 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) 3 months later on study.
干预措施: Discussion (Other)
Arm II (ViRA application)
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.
干预措施: Virtual Reality (Procedure)
Arm I (delayed-start intervention [ViRA application])
Patients receive standard care and then 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) 3 months later on study.
干预措施: Survey Administration (Other)
Arm I (delayed-start intervention [ViRA application])
Patients receive standard care and then 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) 3 months later on study.
干预措施: Virtual Reality (Procedure)
Arm II (ViRA application)
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.
干预措施: Discussion (Other)
Arm II (ViRA application)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Reach - enrollment
时间窗: 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
时间窗: Baseline
Reach of the PPCD ViRA will be measured by the % of AA/BM who accept the ViRA when offered.
Reach - initiation of ViRA
时间窗: 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
时间窗: 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.
次要结局
- Change in emotional support(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months)
- Change in social determinants of health (SDOH) navigation(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months)
- Psycho-oncology support(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months)