Interventions to Improve Colorectal Cancer Screening

Study Overview
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Brief Summary
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We will evaluate if we can increase colorectal cancer screening rates by directly sending screening tests to patients rather than waiting for them to come to clinic visits. We are also evaluating a new test--fecal immunochemical tests--which does not require patients to make dietary or medication changes. We will see if patients are more likely to complete these tests than the standard fecal occult blood tests.

Detailed Description
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Background: Colorectal cancer causes a substantial burden of suffering in the elderly VA population. Although colorectal cancer screening can reduce both the incidence and mortality from colorectal cancer, screening rates are low for the New Mexico VA Health Care System. Objectives: We propose to use the electronic medical record and a new technology for fecal stool testing to improve screening rates and adherence to screening. Methods: The electronic medical record will be used to identify patients who are eligible for screening but who do not have an immediately upcoming primary care clinic appointment. We will enroll a randomly-selected sample of 800 of these patients who have agreed to participate in the study and mail them stool tests along with instructions and educational information about the benefits of screening. We will compare the proportion of subjects who undergo colorectal cancer screening during the 3-month study period against a randomly-selected sample of 400 eligible patients who will require a clinic visit to initiate screening. Because adherence for fecal occult blood tests is low, we also propose to evaluate a new screening technology--fecal immunochemical stool tests which target intact human hemoglobin. These tests can be performed without requiring patients to follow onerous dietary and medication restrictions. We will evaluate whether screening adherence (proportion completing testing) is higher with fecal immunochemical testing (n = 400) compared to the standard fecal occult blood test (n=400). We will also evaluate the yield of advanced neoplasia for each of the screening tests.

Official Title
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Interventions to Improve Colorectal Cancer Screening Rates and Adherence

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Other: Mailed fecal occult blood tests
* Other: Mailed fecal immunochemical tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for stool-based colorectal cancer screening, followed in primary care clinic Exclusion Criteria: Need for surveillance or screening colonoscopy limited life expectancy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Fecal Immunochemical Tests<br>Mailed fecal immunochemical tests | Other: Mailed fecal immunochemical tests<br>* Stool blood test<br>|
| Experimental: Arm 2: Fecal Occult Blood Tests<br>Mailed fecal occult blood tests | Other: Mailed fecal occult blood tests<br>* Stool blood test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer Screening | Completing fecal blood test within 90 days of enrolling | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening