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NCT Number: NCT07796334

Colon Health Champion Program

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

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location contact

Carrie A. Miller, Ph.D, MPH

PRINCIPAL_INVESTIGATOR

Conney W. Berger, III, B.S.

CONTACT

[email protected]

804-933-2913

About this study

Participants in the Colon Health Champion Program will join in a small group discussion and watch videos to learn about colon cancer and why it is important to get checked (screened). They will fill out surveys before and after the meeting, and again one month later. At the end of the discussion, participants may be offered a FIT test to check for colon cancer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • FIT +DNA within the last three years

Treatment and study plan

Intervention Arm: Colon Health Champions (CHC) Program

Behavioral

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

Primary outcomes

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

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

    Meeting participant enrollment within the recruitment window

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

    Time frame: 1 month following intervention

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

Secondary outcomes

  1. Determine Acceptability of Colon Health Champions (CHC)

    Time frame: Immediately following intervention (post-intervention)

    The average participant score from a 9-item satisfaction scale in the post-intervention survey, scored on a 5-point Likert scale where a higher score equals higher satisfaction. The intervention is deemed acceptable with an average score of >/= 3.5

  2. Determine Fidelity of Colon Health Champions (CHC)

    Time frame: Immediately following intervention (post-intervention)

    Determine Fidelity of Colon Health Champions (CHC) Delivery of >/=80% of intervention content as intended, based on fidelity checklist assessing completion of key components of the intervention from 6-item post-intervention debriefing survey. Responses are 1=No, not at all; 2=Started, but NOT completed; 3=Yes, completed.

Study contacts

Contact information is provided by the study sponsor or research team.

Conney W. Berger, III, B.S.

CONTACT

[email protected]

804-933-2913

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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