iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model
研究概览
简要总结
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
详细描述
PRIMARY OBJECTIVES:
I. Plan and develop a PPCD iCCaRE ViRA model that will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.
II: Establish the acceptance and usability of the iCCaRE ViRA among 50 African American/Black men (AA/BM) at local Jacksonville sites.
OUTLINE: This is an observational study. Participants are assigned to 1 of 4 cohorts.
COHORT I: Consumer advocates attend a focus group on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AIM 1: iCCaRE Consortium consumer advocates
- •Clinicians who are part of the Translational Research & Clinical Intervention Services (TRaCIS)
- •AIM 2 ALPHA TESTING: iCCaRE consumer advocates [2 Community Advisory Board (CAB) and 1 non-CAB]
- •AIM 2 BETA TESTING-PATIENTS:
- •An African American/Black male
- •A patient who has been diagnosed with prostate cancer in Florida at any time in their life, and/or within the previous 6 months has had an abnormal Prostate-Specific Antigen (PSA) lab value and/or Digital Rectal Examination (DRE)
- •Minimum age of 30 years old
- •Consent to participating in the intervention
排除标准
- •AIM 2 BETA TESTING-PATIENTS:
- •Patients who are not African American/Black males
- •Patients not diagnosed with prostate cancer in Florida at any time in their life, or within the previous 6 months has not had a normal PSA lab value and/or DRE
- •Older than 80 years old
- •Are not willing to consent
研究组 & 干预措施
Observational cohort I
Consumer advocates attend a focus group on study.
干预措施: Focus group (Other)
Observational cohort V
Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.
干预措施: Virtual Health Intervention (Other)
Observational cohort II
Clinicians complete interviews on study.
干预措施: Clinician Interviews (Other)
Observational cohort III
CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
干预措施: Focus group (Other)
Observational cohort III
CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
干预措施: Intervention testing (Other)
Observational cohort III
CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
干预措施: Survey (Other)
Observational cohort V
Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.
干预措施: Survey (Other)
Observational cohort V
Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.
干预措施: Follow-up Interview (Other)
结局指标
主要结局
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model
时间窗: Up to 4 months
Will be assessed by the length of time needed to create the model. PPCD iCCaRE ViRA model development will be guided by the Translational Research \& Clinical Intervention Services (TRaCIS) and Digital Health \& Human Services (DHHS) core sections of the Inclusive Cancer Care Research Equity (iCCaRE) Consortium. The consortium's scientific team and Community Advisory Board (CAB) will participate in making decisions about how to proceed with the development of the ViRA Intervention and Communication Strategy Plan (ICoSP). This application (app) will be evaluated in Outcomes 2 and 3. The PPCD iCCaRE ViRA app will provide social determinants of health (SDOH) navigation services, psycho-oncology support and emotional support using qualitative formative research.
Acceptance of the iCCaRE ViRA
时间窗: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
Usability of the iCCaRE ViRA
时间窗: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
Usability of the iCCaRE ViRA
时间窗: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
次要结局
未报告次要终点