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Clinical Trials/NCT04304001
NCT04304001CompletedNot Applicable

Test Up Now Education Program

Florida A&M University2 sites in 1 country115 target enrollmentStarted: April 7, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
115
Locations
2
Primary Endpoint
Number of Participants Up to Date on Colorectal Cancer Screening

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Masking Description

Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.

Eligibility Criteria

Ages
45 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Outcomes

Primary Outcomes

Number of Participants Up to Date on Colorectal Cancer Screening

Time Frame: 12 months

The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (\> 1 year but \< 2 years ago; \> 2 years but not more than 5 years ago; or \> 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; \> 1 year but \< 5 years ago; \> 5 years but not more than 10 years ago; or \> 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a "a year ago or less" for the most recent stool blood test and "less than 10 years ago" for most recent colonoscopy are considered up to date.

Secondary Outcomes

  • Colorectal Cancer Screening Knowledge Measure(12 months)
  • Colorectal Cancer Screening Self-Efficacy Scale(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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