Clinical trial NCT06535802: iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
Official title: iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 74
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research \& Clinical Intervention Services core, and non-iCCaRE affiliated member. Representatives from each of the other iCCaRE five projects and six cores/services and non iCCaRE affiliated member. Patients with an abnormal PSA and/or DRE diagnosed with prostate cancer in the state of Florida.

Brief summary: 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:

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 at a urology clinic among 50 Black men (BM).

OUTLINE: This is an observational study. Participants are assigned to 1 of 5 cohorts.

COHORT I: Consumer advocates attend a focus group on study.

COHORT II: Clinicians complete interviews on study.

COHORT III: iCCaRE project representatives test the virtual health intervention, complete a survey, and attend a focus group on study.

COHORT IV: Non iCCaRE affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study.

COHORT V: Patients complete surveys and participate in the virtual health intervention on study. Patients complete survey and an interview during follow up.

Eligibility criteria: Inclusion Criteria:

* AIM 1: iCCaRE Consortium consumer advocates, clinicians as part of the iCCaRE Consortium Translational Research \& Clinical Intervention Services core, and non-iCCaRE affiliated member.
* AIM 2 ALPHA TESTING: 1 representative from each of the other iCCaRE five projects and six cores/services and 1 non iCCaRE affiliated member
* AIM 2 BETA TESTING-PATIENTS:

  * A Black male
  * A patient who has been diagnosed with prostate cancer in Florida
  * Have an abnormal PSA and/or DRE lab value within the previous 6 months
  * Minimum age of 30 yrs
  * Consent to participating in the intervention

Exclusion Criteria:

* AIM 2 BETA TESTING-PATIENTS:

  * Patients who are not Black males
  * Not patients at a urology clinic
  * Have normal PSA and/or DRE lab values within the previous 6 months
  * Older than 80 yrs
  * Are not willing to consent

Primary outcomes:
measure: Point of Prostate Cancer Diagnosis (PPCD) iCCaRE Virtual Robot Assistant (ViRA) model
timeFrame: Up to 4 months
measure: Acceptance of the iCCaRE Virtual Robot Assistant (ViRA)
timeFrame: Baseline; follow-up interview 3-4 months post visit
measure: Usability of the iCCaRE ViRA
timeFrame: Baseline; follow-up interview 3-4 months post visit
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Folakemi T. Odedina, PhD
role: PRINCIPAL_INVESTIGATOR
References: