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Interventions to Improve Colorectal Cancer Screening Rates and Adherence


N/A
50 Years
80 Years
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

Interventions to Improve Colorectal Cancer Screening Rates and Adherence


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Colorectal cancer screening

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Richard M Hoffman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New Mexico VA Health Care System, Albuquerque

Authority:

United States: Federal Government

Study ID:

SHP 08-177

NCT ID:

NCT00692211

Start Date:

June 2008

Completion Date:

April 2009

Related Keywords:

  • Colorectal Neoplasms
  • screening
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

New Mexico VA Health Care System, Albuquerque Albuquerque, New Mexico  87108-5153