N/A N=115 Randomized Single-blind Screening

Test Up Now Education Program

Colorectal Cancer Screening

Bottom Line

View on ClinicalTrials.gov: NCT04304001 ↗

Enrolled (actual)

115

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: Number of Participants Up to Date on Colorectal Cancer Screening — 29; 31 Participants — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Community Health Advisor (Behavioral); Usual care (Behavioral)
Age: Adult · 45+ yrs
Sex: All
Sponsor: Florida A&M University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Up to Date on Colorectal Cancer Screening	29; 31	<0.05 sig
SECONDARY Colorectal Cancer Screening Knowledge Measure	10.42; 9.88	<0.05 sig
SECONDARY Colorectal Cancer Screening Self-Efficacy Scale	1.86; 1.98	<0.05 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

under 45 years or over 64 years of age
do not self-identify as African American
do not have a working cellphone or telephone
not a resident of Florida
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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04304001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.