NCT07173985

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

September 8, 2025

Last Update Submit

January 21, 2026

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • FIT Return

    Proportion of participants who return of a completed FIT kit

    Within 8 weeks of FIT kit distribution

Study Arms (4)

Group A (standard FIT kit plus telephone PN)

EXPERIMENTAL

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

Behavioral: Standard FIT kitBehavioral: Telephone patient navigation

Group B (standard FIT kit plus text message PN)

EXPERIMENTAL

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

Behavioral: Standard FIT kitBehavioral: Text message patient navigation

Group C (enhanced FIT kit plus telephone PN)

EXPERIMENTAL

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

Behavioral: Enhanced FIT kitBehavioral: Telephone patient navigation

Group D (enhanced FIT kit plus text message PN)

EXPERIMENTAL

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

Behavioral: Enhanced FIT kitBehavioral: Text message patient navigation

Interventions

Standard FIT kitBEHAVIORAL

Receive a standard FIT kit

Group A (standard FIT kit plus telephone PN)Group B (standard FIT kit plus text message PN)
Enhanced FIT kitBEHAVIORAL

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

Group C (enhanced FIT kit plus telephone PN)Group D (enhanced FIT kit plus text message PN)
Telephone patient navigationBEHAVIORAL

Receive telephone-based patient navigation

Group A (standard FIT kit plus telephone PN)Group C (enhanced FIT kit plus telephone PN)
Text message patient navigationBEHAVIORAL

Receive text message-based patient navigation

Group B (standard FIT kit plus text message PN)Group D (enhanced FIT kit plus text message PN)

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Paul Reiter, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware of the research questions being tested in the trial.
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

January 20, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)