Actively Recruiting

Phase Not Applicable
Age: 45Years - 74Years
All Genders
ID07173985

Strategies for Optimizing a Mailed FIT Program in Appalachia

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-01-22

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Ohio State University Comprehensive Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate strategies to improve colorectal cancer screening rates in residents of Appalachian counties who are at average risk and not currently up to date with screening. The study focuses on mailed fecal immunochemical test (FIT) programs, assessing two key factors: the type of FIT kit materials and the mode of patient navigation delivery. Participants are randomly assigned to one of four groups combining two types of FIT kits and two patient navigation methods. Groups receive either a standard FIT kit or an enhanced FIT kit, which includes additional materials such as a video brochure, disposable gloves, and a disposable stool collection device. Patient navigation is provided either via telephone or text message to support participants in completing the screening process. During the study, participants complete the FIT screening within 8 weeks of receiving the kit. Researchers monitor the return of FIT kits to measure the effectiveness of each combination of materials and navigation methods. The study involves adults aged 45 to 74 who have had a medical visit in the past two years at a participating health system. The total duration and follow-up details are based on this screening completion timeframe.

CONDITIONS

Brief Title

Strategies for Optimizing a Mailed FIT Program in Appalachia

Who Can Participate

Age: 45Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resident of an Appalachian county
  • Medical visit at a participating health system in the past two years
  • Average-risk for colorectal cancer
  • Not currently within colorectal cancer screening guidelines
  • Age between 45 and 74 years
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 8 weeks

Participants receive FIT kits with patient navigation to support colorectal cancer screening.

FIT kit distribution and follow-up contacts through telephone or text message navigation

Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SCREENING

Number of Arms

4

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