Strategies for Optimizing a Mailed FIT Program in Appalachia

July 8, 2026 updated by: Paul Reiter, Ohio State University Comprehensive Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Paul Reiter
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (standard FIT kit plus telephone PN)
Participants receive standard FIT kit plus telephone patient navigation (PN)
Behavioral: Standard FIT kit
Receive a standard FIT kit
Behavioral: Telephone patient navigation
Receive telephone-based patient navigation
Experimental: Group B (standard FIT kit plus text message PN)
Participants receive standard FIT kit plus text message patient navigation (PN)
Behavioral: Standard FIT kit
Receive a standard FIT kit
Behavioral: Text message patient navigation
Receive text message-based patient navigation
Experimental: Group C (enhanced FIT kit plus telephone PN)
Participants receive enhanced FIT kit plus telephone patient navigation (PN)
Behavioral: Telephone patient navigation
Receive telephone-based patient navigation
Behavioral: Enhanced FIT kit
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
Experimental: Group D (enhanced FIT kit plus text message PN)
Participants receive enhanced FIT kit plus text message patient navigation (PN)
Behavioral: Text message patient navigation
Receive text message-based patient navigation
Behavioral: Enhanced FIT kit
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIT Return
Time Frame: Within 8 weeks of FIT kit distribution
Proportion of participants who return of a completed FIT kit
Within 8 weeks of FIT kit distribution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Actual)

September 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-24377
  • R01CA282162 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe