Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 45 Years and 74 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Screening
Masking
Single (Participant)
Masking Description
Participants are not aware of the research questions being tested in the trial.

Arm Groups

ArmDescriptionAssigned Intervention
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: Enhanced FIT kit
    Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
  • Behavioral: Telephone patient navigation
    Receive telephone-based patient navigation
Experimental
Group D (enhanced FIT kit plus text message PN) 		Participants receive enhanced FIT kit plus text message patient navigation (PN)
  • Behavioral: Enhanced FIT kit
    Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
  • Behavioral: Text message patient navigation
    Receive text message-based patient navigation

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Paul Reiter, PhD
614-292-4803
reiter.36@osu.edu

More Details

Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.