Strategies for Optimizing a Mailed FIT Program in Appalachia

Not Applicable

Not yet recruiting

• Conditions: Colonic Neoplasms

• Registration Number: NCT07173985
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.

Detailed Description

PRIMARY OBJECTIVES:

Determine the efficacy of two strategies for increasing colorectal cancer screening.

OUTLINE: Participants are randomized to 1 of 4 groups.

GROUP I: Participants receive a standard FIT kit plus telephone patient navigation.

GROUP II: Participants receive a standard FIT kit plus text message patient navigation.

GROUP III: Participants receive an enhanced FIT kit plus telephone patient navigation.

GROUP IV: Participants receive an enhanced FIT kit plus text message patient navigation.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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

Exclusion Criteria

-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
FIT Return	Within 8 weeks of FIT kit distribution	Proportion of participants who return of a completed FIT kit

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States