Clinical trial NCT00692211: Interventions to Improve Colorectal Cancer Screening
Official title: Interventions to Improve Colorectal Cancer Screening Rates and Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: screening
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-06
Enrollment: 404
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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 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

Primary outcomes:
measure: Colorectal Cancer Screening
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
Study officials:
affiliation: New Mexico VA Health Care System, Albuquerque, NM
name: Richard M Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffman RM, Steel SR, Yee EF, Massie L, Schrader RM, Moffett ML, Murata GH. A system-based intervention to improve colorectal cancer screening uptake. Am J Manag Care. 2011 Jan;17(1):49-55.
citation: Hoffman RM, Steel S, Yee EF, Massie L, Schrader RM, Murata GH. Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial. Prev Med. 2010 May-Jun;50(5-6):297-9. doi: 10.1016/j.ypmed.2010.03.010. Epub 2010 Mar 20.