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Engaging Black Men in Colorectal Cancer Screening (SUCCEED)

Primary Purpose

Colorectal Cancer, CRC, Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Application
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Screening behaviors

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Adult men Identify as Black or African American Work or live in Petersburg, VA or surrounding counties Eligible for colorectal cancer (CRC) screening at time of study enrollment Exclusion Criteria: Inability to speak or read English Currently up-to-date with CRC screening

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tailored Screen to Save (S2S) content

Arm Description

Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.

Outcomes

Primary Outcome Measures

Colorectal Screening Status
The number of participants that complete screening (any type)

Secondary Outcome Measures

Determine feasibility of Mobile Health (mHealth) Application -Enrollment
The number of men that enroll for the intervention (application)
Determine the feasibility of the mHealth Application-Videos
The number of participants that view the videos
Determine the feasibility of the mHealth Application- Retention
The number of participants that complete Questionnaires (>75%)
Determine the feasibility of the mHealth Application- Clinic/ Screening Request
The number of participants that respond to the request to contact clinic/ navigation services
Determine the feasibility of the mHealth Application - Sharing Content
The number of participants that share content on social network

Full Information

First Posted
July 27, 2023
Last Updated
August 29, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05980182
Brief Title
Engaging Black Men in Colorectal Cancer Screening
Acronym
SUCCEED
Official Title
SUCCEED: Engaging Black Men in Colorectal Cancer Screening (CRC) Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, CRC, Behavior
Keywords
Colorectal Screening behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tailored Screen to Save (S2S) content
Arm Type
Experimental
Arm Description
Content to be delivered using a combination of short video and text-based information optimized for delivery via Quick Response (QR) codes for smartphones.
Intervention Type
Behavioral
Intervention Name(s)
mHealth Application
Intervention Description
Self-directed application (app) that is downloaded to the participant's personal device. The app contains five informational videos, that provide an orientation to the content on the app, and discuss what colorectal cancer is, and the type of CRC screening tests that are available as well as a video with a personal history. There is a a National Cancer Institute (NCI) risk calculation tool, and a family history infographic. Once the videos have been viewed participants have the option to indicate if they wish to receive a call from the healthcare clinic to discuss scheduling an appointment for screening.
Primary Outcome Measure Information:
Title
Colorectal Screening Status
Description
The number of participants that complete screening (any type)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Determine feasibility of Mobile Health (mHealth) Application -Enrollment
Description
The number of men that enroll for the intervention (application)
Time Frame
Week 1
Title
Determine the feasibility of the mHealth Application-Videos
Description
The number of participants that view the videos
Time Frame
Week 1
Title
Determine the feasibility of the mHealth Application- Retention
Description
The number of participants that complete Questionnaires (>75%)
Time Frame
Baseline (Day 1), Week 2, and Week 12
Title
Determine the feasibility of the mHealth Application- Clinic/ Screening Request
Description
The number of participants that respond to the request to contact clinic/ navigation services
Time Frame
Week 12
Title
Determine the feasibility of the mHealth Application - Sharing Content
Description
The number of participants that share content on social network
Time Frame
Week 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult men Identify as Black or African American Work or live in Petersburg, VA or surrounding counties Eligible for colorectal cancer (CRC) screening at time of study enrollment Exclusion Criteria: Inability to speak or read English Currently up-to-date with CRC screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Thomson, Ph.D.
Phone
804-628-2640
Email
mthomson2@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Thomson, Ph.D.
Organizational Affiliation
Virginia Commonwealt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Thomson, Ph.D.
Phone
804-628-2640
Email
mthomson2@vcu.edu
First Name & Middle Initial & Last Name & Degree
Maria Thomson, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Engaging Black Men in Colorectal Cancer Screening

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