Back to resultsAssessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study (MiCaP)
Primary Purpose
Prostate Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Media Intervention
Media Intervention
Survey Administration
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Carcinoma
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MiCaP Research Digest Video Group
Alternate Video Group
Arm Description
Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.
Participants watch an alternative video on study. Participants complete a survey throughout the trial.
Outcomes
Primary Outcome Measures
Change in perception of access to medical services and general health
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
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05895279
Brief Title
Assessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study
Acronym
MiCaP
Official Title
Minority Prostate Cancer (MiCaP) Phase III (Aim 3): Assessment of Research Digest Impact
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2002 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MiCaP Research Digest Video Group
Arm Type
Experimental
Arm Description
Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.
Arm Title
Alternate Video Group
Arm Type
Active Comparator
Arm Description
Participants watch an alternative video on study. Participants complete a survey throughout the trial.
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
Watch MiCaP Research Digest video
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
Watch alternate video
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Primary Outcome Measure Information:
Title
Change in perception of access to medical services and general health
Description
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.
Time Frame
Baseline, 1 hour after video intervention
Title
Change in perception in participation with clinical trials about prostate cancer
Description
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.
Time Frame
Baseline, 1 hour after video intervention
Title
Change in perception of familiarity with prostate cancer research
Description
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.
Time Frame
Baseline, 1 hour after video intervention
Title
Change in perception of familiarity with a research study protocol
Description
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.
Time Frame
Baseline, 1 hour after video intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Folakemi T Odedina
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Folakemi T. Odedina, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Assessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study
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