Strategies for Optimizing a Mailed FIT Program in Appalachia

NCT ID: NCT07173985

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2028-07-31

Brief Summary

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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

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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.

Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Participants are not aware of the research questions being tested in the trial.

Study Groups

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Group A (standard FIT kit plus telephone PN)

Participants receive standard FIT kit plus telephone patient navigation (PN)

Group Type EXPERIMENTAL

Standard FIT kit

Intervention Type BEHAVIORAL

Receive a standard FIT kit

Telephone patient navigation

Intervention Type BEHAVIORAL

Receive telephone-based patient navigation

Group B (standard FIT kit plus text message PN)

Participants receive standard FIT kit plus text message patient navigation (PN)

Group Type EXPERIMENTAL

Standard FIT kit

Intervention Type BEHAVIORAL

Receive a standard FIT kit

Text message patient navigation

Intervention Type BEHAVIORAL

Receive text message-based patient navigation

Group C (enhanced FIT kit plus telephone PN)

Participants receive enhanced FIT kit plus telephone patient navigation (PN)

Group Type EXPERIMENTAL

Enhanced FIT kit

Intervention Type BEHAVIORAL

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

Telephone patient navigation

Intervention Type BEHAVIORAL

Receive telephone-based patient navigation

Group D (enhanced FIT kit plus text message PN)

Participants receive enhanced FIT kit plus text message patient navigation (PN)

Group Type EXPERIMENTAL

Enhanced FIT kit

Intervention Type BEHAVIORAL

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

Text message patient navigation

Intervention Type BEHAVIORAL

Receive text message-based patient navigation

Interventions

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Standard FIT kit

Receive a standard FIT kit

Intervention Type BEHAVIORAL

Enhanced FIT kit

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

Intervention Type BEHAVIORAL

Telephone patient navigation

Receive telephone-based patient navigation

Intervention Type BEHAVIORAL

Text message patient navigation

Receive text message-based patient navigation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Paul Reiter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Reiter, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Paul Reiter, PhD

Role: primary

614-292-4803

Role: backup

Related Links

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Other Identifiers

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R01CA282162

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-24377

Identifier Type: -

Identifier Source: org_study_id

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