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Interventions to Improve Colorectal Cancer Screening

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Other: Mailed fecal occult blood tests
Other: Mailed fecal immunochemical tests

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00692211
SHP 08-177

Details and patient eligibility

About

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.

Full description

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.

Enrollment

404 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

404 participants in 2 patient groups

Arm 1: Fecal Immunochemical Tests
Experimental group
Description:
Mailed fecal immunochemical tests
Treatment:
Other: Mailed fecal immunochemical tests
Arm 2: Fecal Occult Blood Tests
Experimental group
Description:
Mailed fecal occult blood tests
Treatment:
Other: Mailed fecal occult blood tests

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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