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Recruiting

NCT Number: NCT07173985

Strategies for Optimizing a Mailed FIT Program in Appalachia

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.

Recruiting

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Paul Reiter

PRINCIPAL_INVESTIGATOR

Paul Reiter, PhD

CONTACT

[email protected]

614-292-4803

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Standard FIT kit

Behavioral

Receive a standard FIT kit

Enhanced FIT kit

Behavioral

Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device

Telephone patient navigation

Behavioral

Receive telephone-based patient navigation

Text message patient navigation

Behavioral

Receive text message-based patient navigation

Primary outcomes

  1. FIT Return

    Time frame: Within 8 weeks of FIT kit distribution

    Proportion of participants who return of a completed FIT kit

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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