NCT05980182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

August 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

July 27, 2023

Results QC Date

June 24, 2025

Last Update Submit

August 4, 2025

Conditions

Colorectal CancerCRCBehavior

Keywords

Colorectal Screening behaviors

Outcome Measures

Primary Outcomes (1)

  • Colorectal Screening Status

    The number of participants that complete screening (any type)

    3 Months

Secondary Outcomes (5)

  • Determine Feasibility of Mobile Health (mHealth) Application -Enrollment

    Week 1

  • Determine the Feasibility of the mHealth Application-Videos

    Week 1

  • Determine the Feasibility of the mHealth Application- Retention

    Baseline (Day 1), Week 2, and Week 12

  • Determine the Feasibility of the mHealth Application- Clinic/ Screening Request

    Week 12

  • Determine the Feasibility of the mHealth Application - Sharing Content

    Week 12

Study Arms (1)

Tailored Screen to Save (S2S) content

EXPERIMENTAL

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

Behavioral: mHealth Application

Interventions

mHealth ApplicationBEHAVIORAL

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.

Tailored Screen to Save (S2S) content

Eligibility Criteria

Age45 Years - 74 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to speak or read English
  • Currently up-to-date with CRC screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Thomson MD, Shahab GH, Cooper-McGill CA, Sheppard VB, Hill SS, Preston M, Keen Ii L. Increasing Colorectal Cancer Screening Among Black Men in Virginia: Development of an mHealth Intervention. JMIR Form Res. 2024 Oct 10;8:e50028. doi: 10.2196/50028.

    PMID: 39388688DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsBehavior

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Dr. Maria Thomson
Organization
Virginia Commonwealth University
mthomson2@vcu.edu
804-628-2640

Study Officials

  • Maria Thomson, Ph.D.

    Virginia Commonwealt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 7, 2023

Study Start

August 5, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

August 20, 2025

Results First Posted

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)