Colon Health Champion Program

NCT07796334 | Not Yet Recruiting DMC

• 2 other identifiers: MCC-24-21317HM20031882
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm-proof-of-concept trial. The primary goal of this trial is to assess the feasibility and acceptability of the Colon Health Champion Program

Conditions

Colorectal Cancer; CRC

Outcome Measures

Primary Outcomes (2)

• Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment

  Meeting participant enrollment within the recruitment window

  Day the last participant is enrolled, and the protocol closes to accrual, (estimated enrollment duration is up to 12 months)

• Determine feasibility of Colon Health Champions (CHC) Intervention - Participation

  Achieving \>/=70% participation retention at the 1-month follow-up assessment.

  1 month following intervention

Secondary Outcomes (2)

• Determine Acceptability of Colon Health Champions (CHC)

  Immediately following intervention (post-intervention)

• Determine Fidelity of Colon Health Champions (CHC)

  Immediately following intervention (post-intervention)

Study Arms (1)

Proof-of-concept trial to assess the Colon Health Champion Program

EXPERIMENTAL

Participants will attend an in-person small group discussion. The discussion will teach participants about colon cancer and why it is important to get checked (screened).

Behavioral: Intervention Arm: Colon Health Champions (CHC) Program

Interventions

Intervention Arm: Colon Health Champions (CHC) Program BEHAVIORAL

Peer-led interventions will discuss colorectal cancer (CRC) susceptibility and severity, and potential barriers to screening.

Proof-of-concept trial to assess the Colon Health Champion Program

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged (45-75 years old) who reside in target communities.
• Ability to speak, write, and comprehend English language
• Additional for trial participants only (not champions): Participants will include adults who are at average risk of colorectal cancer (CRC) and due for routine CRC screening.

You may not qualify if:

• Planning to move from the area within the study period
• Cognitive impairment that would preclude informed consent or completion of study measures
• Additional for Trial Participants only (not Champions):
• At elevated risk of CRC, defined as having one or more of the following:
• Personal history of CRC, adenomatous polyps, or inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
• Strong family history of CRC, defined as having one first-degree relative diagnosed at age 59 or younger or two or more first-degree relatives who have had CRC
• Known hereditary CRC syndromes (e.g., Lynch syndrome or familial adenomatous polyposis \[FAP\])
• Currently experiencing potential colorectal symptoms, including:
• Blood in stool or rectal bleeding
• Persistent changes in bowel habits (e.g., constipation or changes in stool shape lasting more than two weeks)
• Unintended or unexplained weight loss
• Severe fatigue or anemia
• Currently up-to-date with CRC screening, defined as having received any of the following tests:
• Colonoscopy within the last ten years
• FIT within the last year

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Clathrin Heavy Chains

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clathrin; Vesicular Transport Proteins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Carrie A. Miller, Ph.D, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conney W. Berger, III, B.S.

CONTACT

804-933-2913; Conney.Berger@vcuhealth.org

Study Design

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

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)