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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH2210968 | Other Grant/Funding Number | Department of Defense | |
| NCI-2024-05156 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC220501 | Other Identifier | Mayo Clinic in Florida | |
| 22-001412 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
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.
COHORT II: Clinicians complete interviews on study.
COHORT III: CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study.
COHORT IV: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational cohort I | Consumer advocates attend a focus group on study. |
| |
| Observational cohort II | Clinicians complete interviews on study. |
| |
| Observational cohort III | CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study. |
| |
| Observational cohort V | Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus group | Other | Attend a focus group session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model | 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. | Up to 4 months |
| Acceptance of the iCCaRE ViRA | Will be assessed by patient immediate reaction and patient delayed feedback. | Baseline; follow-up interview 3-4 months post visit |
| Usability of the iCCaRE ViRA | Will be assessed by patient immediate reaction and patient delayed feedback. | Baseline; follow-up interview 3-4 months post visit |
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Inclusion Criteria:
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:
Exclusion Criteria:
AIM 2 BETA TESTING-PATIENTS:
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iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research & Clinical Intervention Services. Community Advisory Board (CAB) and non-CAB iCCaRE consumer advocates. Patients with an abnormal PSA and/or DRE diagnosed with prostate cancer in the state of Florida.
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| Name | Affiliation | Role |
|---|---|---|
| Folakemi T. Odedina, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Clinician Interviews | Other | Participate in clinician interviews |
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| Intervention testing | Other | Test the virtual health intervention |
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| Survey | Other | Complete a follow-up survey |
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| Follow-up Interview | Other | Participate in a follow-up interview |
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| Virtual Health Intervention | Other | Participate in the virtual health intervention |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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