Assessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study (MiCaP)

January 17, 2024 updated by: Mayo Clinic

Minority Prostate Cancer (MiCaP) Phase III (Aim 3): Assessment of Research Digest Impact

This phase III trial determines how well the Minority Prostate Cancer (MiCaP) Research Digest works in providing information to black men about the latest prostate cancer research. MiCaP Research Digest may be an effective method to help people learn about prostate cancer.This goal of this trial is to create educational programming that helps Black men make informed decisions about their prostate healthcare since Black men are diagnosed with prostate cancer more than any other race or ethnicity.

Study Overview

Detailed Description

PRIMARY OBJECTIVE:

I. To develop a research dissemination program, the Minority Prostate Cancer (MiCaP) Research Digest, which will spread information about CaP scientific discoveries, evidence-based interventions, and open clinical trials instantly among black males (BM).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.

ARM II: Participants watch an alternative video on study. Participants complete a survey throughout the trial.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Folakemi T. Odedina, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Identify as a Black male
  • Between the ages of 35 and 70
  • For virtual data collection, have access to the internet and Zoom (if joining study online)
  • For virtual data collection, reside anywhere in the U.S.
  • For in-person data collection, reside in one of the nine (9) catchment areas of the Mayo Clinic Cancer Center: Baker, Duval, Nassau, Clay, St. John's, Putnam, Flagler, Volusia and Brevard

Exclusion Criteria:

  • Identify as a race or ethnicity that is not Black
  • Identify as female
  • Be younger than age 35 and older than age 70
  • Lack access to internet and Zoom (if joining study online)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MiCaP Research Digest Video Group
Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.
Complete survey
Watch MiCaP Research Digest video
Watch alternate video
Active Comparator: Alternate Video Group
Participants watch an alternative video on study. Participants complete a survey throughout the trial.
Complete survey
Watch MiCaP Research Digest video
Watch alternate video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in perception of access to medical services and general health
Time Frame: Baseline, 1 hour after video intervention
Using the Minority Prostate Cancer (MiCaP) survey developed for this study, participants are asked 10 questions regarding access to medical services and general health with a yes/no response.
Baseline, 1 hour after video intervention
Change in perception in participation with clinical trials about prostate cancer
Time Frame: Baseline, 1 hour after video intervention
Using the Minority Prostate Cancer (MiCaP) survey developed for this study, participants are asked 10 questions regarding views on participating in clinical trials about prostate cancer with a yes/no response.
Baseline, 1 hour after video intervention
Change in perception of familiarity with prostate cancer research
Time Frame: Baseline, 1 hour after video intervention
Using the Minority Prostate Cancer (MiCaP) survey developed for this study, participants are asked 5 questions regarding views on participating in clinical trials about prostate cancer with a true/false/don't know response.
Baseline, 1 hour after video intervention
Change in perception of familiarity with a research study protocol
Time Frame: Baseline, 1 hour after video intervention
Using the Minority Prostate Cancer (MiCaP) survey developed for this study, participants are asked 5 questions regarding information about a study protocol with a true/false/don't know response.
Baseline, 1 hour after video intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Folakemi T. Odedina, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2002

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 21-006715 (Other Identifier: Mayo Clinic Institutional Review Board)
  • MiCaP (Other Identifier: Mayo Clinic in Florida)
  • NCI-2022-09906 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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