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: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Other: Fecal occult blood test
Other: Fecal immunochemical testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Interventions to Improve Colorectal Cancer Screening Rates and Adherence

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Colorectal cancer screening [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Usual care
Experimental: Arm 2
Mailed fecal occult blood tests
Other: Fecal occult blood test
Stool blood test
Experimental: Arm 3
Mailed fecal immunochemical tests
Other: Fecal immunochemical testing
Stool blood test

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692211

Locations
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
Sponsors and Collaborators
Investigators
Principal Investigator: Richard M Hoffman, MD New Mexico VA Health Care System, Albuquerque
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00692211     History of Changes
Other Study ID Numbers: SHP 08-177
Study First Received: June 3, 2008
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
screening

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 26, 2014