Colon Health Champion Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorVirginia Commonwealth University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Planning to move from the area within the study period
Cognitive impairment that would preclude informed consent or completion of study measures
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
Trial design
Design model
Single group
Treatments tested in this trial
Intervention Arm: Colon Health Champions (CHC) Program
BehavioralPeer-led interventions will discuss colorectal cancer (CRC) susceptibility and severity, and potential barriers to screening.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Proof-of-concept trial to assess the Colon Health Champion ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment
Meeting participant enrollment within the recruitment window
Time frame
Day the last participant is enrolled, and the protocol closes to accrual, (estimated enrollment duration is up to 12 months)2
Determine feasibility of Colon Health Champions (CHC) Intervention - Participation
Achieving \>/=70% participation retention at the 1-month follow-up assessment.
Time frame
1 month following interventionSecondary outcomes
1
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
Time frame
Immediately following intervention (post-intervention)2
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.
Time frame
Immediately following intervention (post-intervention)Sponsors and contacts
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Source ClinicalTrials.gov
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