Colorectal CancerNCT07796334
Colon Health Champion Program
A study testing Intervention Arm: Colon Health Champions (CHC) Program in people with Colorectal Cancer and CRC, run by Virginia Commonwealth University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, CRC
- What is being tested?
- Intervention Arm: Colon Health Champions (CHC) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Conney W. Berger, III, B.S., 804-933-2913, Conney.Berger@vcuhealth.org
Carrie A. Miller, Ph.D, MPH
About this study
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
Read the detailed description
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.
- Conditions
- Colorectal Cancer, CRC
- Being tested
- Intervention Arm: Colon Health Champions (CHC) Program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Arm: Colon Health Champions (CHC) ProgramBehavioural
Peer-led interventions will discuss colorectal cancer (CRC) susceptibility and severity, and potential barriers to screening.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Intervention Arm: Colon Health Champions (CHC) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment
Meeting participant enrollment within the recruitment window
Measured: 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.
Measured: 1 month following intervention
Secondary outcomes (2)
Determine Acceptability of Colon Health Champions (CHC)
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
Measured: Immediately following intervention (post-intervention)
Determine Fidelity of Colon Health Champions (CHC)
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.
Measured: Immediately following intervention (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carrie A. Miller, Ph.D, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796334
- Sponsor's protocol ID
- MCC-24-21317
- Other IDs
- HM20031882
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Health Champion Program
- ClinicalTrials.gov ID
- NCT07796334
- Acronym / sponsor ID
- MCC-24-21317
- Conditions
- Colorectal Cancer, CRC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proof-of-concept trial to assess the Colon Health Champion Program | Experimental | Behavioral: Intervention Arm: Colon Health Champions (CHC) ProgramParticipants 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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Arm: Colon Health Champions (CHC) ProgramPeer-led interventions will discuss colorectal cancer (CRC) susceptibility and severity, and potential barriers to screening. | Behavioural | Proof-of-concept trial to assess the Colon Health Champion Program |
Primary outcome
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
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.
2 secondary outcomes
Determine Acceptability of Colon Health Champions (CHC)
Time frame: Immediately following intervention (post-intervention)
Determine Fidelity of Colon Health Champions (CHC)
Time frame: Immediately following intervention (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie A. Miller, Ph.D, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm: Colon Health Champions (CHC) Program in people with Colorectal Cancer and CRC, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conney W. Berger, III, B.S. (804-933-2913, Conney.Berger@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.