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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05895279

Collaborator

(none)

420

Enrollment

Location

Arms

269

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Carcinoma	Other: Media Intervention Other: Media Intervention Other: Survey Administration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 2, 2002

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: MiCaP Research Digest Video Group

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

Other: Media Intervention

Watch MiCaP Research Digest video

Other: Survey Administration

Complete survey

Active Comparator: Alternate Video Group

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

Other: Media Intervention

Watch alternate video

Other: Survey Administration

Complete survey

Outcome Measures

Primary Outcome Measures

Change in perception of access to medical services and general health [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.
Change in perception in participation with clinical trials about prostate cancer [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.
Change in perception of familiarity with prostate cancer research [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.
Change in perception of familiarity with a research study protocol [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Folakemi T Odedina, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05895279

Other Study ID Numbers:

MiCaP
NCI-2022-09906
21-006715
MiCaP

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 8, 2023