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Interventions to Improve Colorectal Cancer Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00692211
First received: June 3, 2008
Last updated: August 11, 2014
Last verified: August 2014

June 3, 2008
August 11, 2014
June 2008
April 2009   (final data collection date for primary outcome measure)
Colorectal Cancer Screening [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Completing fecal blood test within 90 days of enrolling
Colorectal cancer screening [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00692211 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interventions to Improve Colorectal Cancer Screening
Interventions to Improve Colorectal Cancer Screening Rates and Adherence

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Colorectal Neoplasms
  • Other: Mailed fecal occult blood tests
    Stool blood test
  • Other: Mailed fecal immunochemical tests
    Stool blood test
  • Experimental: Arm 2
    Mailed fecal occult blood tests
    Intervention: Other: Mailed fecal occult blood tests
  • Experimental: Arm 1
    Mailed fecal immunochemical tests
    Intervention: Other: Mailed fecal immunochemical tests

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00692211
SHP 08-177
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard M Hoffman, MD New Mexico VA Health Care System, Albuquerque
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP