Colorectal Cancer, CRC
Conditions
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
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.
Interventions
BEHAVIORALIntervention Arm: Colon Health Champions (CHC) Program
Peer-led interventions will discuss colorectal cancer (CRC) susceptibility and severity, and potential barriers to screening.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine feasibility of Colon Health Champions (CHC)-Successful Recruitment | 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 | 1 month following intervention | Achieving \>/=70% participation retention at the 1-month follow-up assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine Acceptability of Colon Health Champions (CHC) | 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 |
| Determine Fidelity of Colon Health Champions (CHC) | 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. |
Countries
United States
Contacts
CONTACTConney W. Berger, III, B.S.
PRINCIPAL_INVESTIGATORCarrie A. Miller, Ph.D, MPH
Virginia Commonwealth University
Outcome results
None listed