NCT04304001Completed
Test Up Now Education Program
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 115 (actual)
- First submitted
- 24 Feb 2020
- Start date
- 7 Apr 2021
- Primary completion date
- 12 Feb 2024
- Lead sponsor
- Florida A&M University
- Diseases
- Colorectal cancer
- NCT number
- NCT04304001
What you commit to
- Study type: Interventional
- Participants enrolled: 115
- From 7 Apr 2021 to the primary completion date, 12 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- are adherent with colorectal cancer screening guidelines (i.e., stool-based tests \< 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or
- have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Age
- under 45 years or over 64 years of age
Other
- do not self-identify as African American
- do not have a working cellphone or telephone
- not a resident of Florida
Who the study is looking for
- are 45 years to 64 years of age
- self-identify as African American
- have a working cellphone or telephone
- are a resident of Florida
- are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests \> 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years)
- have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Age in the registry: 45 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Florida A&M University Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.