Prostate CarcinomaNCT06535802
iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
An observational study of Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Focus group, Clinician Interviews and Intervention testing
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 23 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Focus group, Clinician Interviews, Intervention testing, Survey, Follow-up Interview
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Attend a focus group session
Clinician InterviewsOther
Participate in clinician interviews
Intervention testingOther
Test the virtual health intervention
SurveyOther
Complete a follow-up survey
Follow-up InterviewOther
Participate in a follow-up interview
Virtual Health InterventionOther
Participate in the virtual health intervention
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort I | Consumer advocates attend a focus group on study. Receives: Other: Focus group | |
| Observational cohort II | Clinicians complete interviews on study. Receives: Other: Clinician Interviews | |
| Observational cohort III | CaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study. Receives: Other: Focus group; Other: Intervention testing; Other: Survey | |
| Observational cohort V | Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up. Receives: Other: Survey; Other: Follow-up Interview; Other: Virtual Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 months
Acceptance of the iCCaRE ViRA
Will be assessed by patient immediate reaction and patient delayed feedback.
Measured: 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.
Measured: Baseline; follow-up interview 3-4 months post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start20 Nov 2023
- Primary completion23 Jun 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Folakemi T. Odedina, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535802
- Sponsor's protocol ID
- MC220501
- Other IDs
- W81XWH2210968, NCI-2024-05156, 22-001412
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
- ClinicalTrials.gov ID
- NCT06535802
- Acronym / sponsor ID
- MC220501
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observational cohort I | – | Other: Focus groupConsumer advocates attend a focus group on study. |
| Observational cohort II | – | Other: Clinician InterviewsClinicians complete interviews on study. |
| Observational cohort III | – | Other: Focus group, Other: Intervention testing, Other: SurveyCaP survivors test the virtual health intervention, complete a survey, and attend a focus group on study. |
| Observational cohort V | – | Other: Survey, Other: Follow-up Interview, Other: Virtual Health InterventionPatients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- AIM 2 BETA TESTING-PATIENTS:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupAttend a focus group session | Other | Observational cohort I, Observational cohort III |
| Clinician InterviewsParticipate in clinician interviews | Other | Observational cohort II |
| Intervention testingTest the virtual health intervention | Other | Observational cohort III |
| SurveyComplete a follow-up survey | Other | Observational cohort III, Observational cohort V |
| Follow-up InterviewParticipate in a follow-up interview | Other | Observational cohort V |
| Virtual Health InterventionParticipate in the virtual health intervention | Other | Observational cohort V |
Primary outcome
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model
Time frame: 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
Time frame: 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
Time frame: Baseline; follow-up interview 3-4 months post visit
Will be assessed by patient immediate reaction and patient delayed feedback.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Folakemi T. Odedina, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Reality Assistant (ViRA) model (time frame: Up to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.