Strategies for Optimizing a Mailed FIT Program in Appalachia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard FIT kit, Enhanced FIT kit, Telephone patient navigation, Text message patient navigation.
- Who it may be relevant to
- Registry conditions: Colonic Neoplasms. Basic parameters: 45 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Behavioral Standard FIT kit
Receive a standard FIT kit - 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 - Behavioral Text message patient navigation
Receive text message-based patient navigation
Primary outcome measures
- FIT Return [Time frame: Within 8 weeks of FIT kit distribution]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT07173985 · OSU-24377 · R01CA282162