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Interventions to Improve Colorectal Cancer Screening

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mailed fecal occult blood tests
Mailed fecal immunochemical tests
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms focused on measuring screening

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • New Mexico VA Health Care System, Albuquerque, NM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Fecal Immunochemical Tests

Arm 2: Fecal Occult Blood Tests

Arm Description

Mailed fecal immunochemical tests

Mailed fecal occult blood tests

Outcomes

Primary Outcome Measures

Colorectal Cancer Screening
Completing fecal blood test within 90 days of enrolling

Secondary Outcome Measures

Full Information

First Posted
June 3, 2008
Last Updated
April 28, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00692211
Brief Title
Interventions to Improve Colorectal Cancer Screening
Official Title
Interventions to Improve Colorectal Cancer Screening Rates and Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Fecal Immunochemical Tests
Arm Type
Experimental
Arm Description
Mailed fecal immunochemical tests
Arm Title
Arm 2: Fecal Occult Blood Tests
Arm Type
Experimental
Arm Description
Mailed fecal occult blood tests
Intervention Type
Other
Intervention Name(s)
Mailed fecal occult blood tests
Intervention Description
Stool blood test
Intervention Type
Other
Intervention Name(s)
Mailed fecal immunochemical tests
Intervention Description
Stool blood test
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening
Description
Completing fecal blood test within 90 days of enrolling
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Hoffman, MD
Organizational Affiliation
New Mexico VA Health Care System, Albuquerque, NM
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Mexico VA Health Care System, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5153
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21348568
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.
Results Reference
result
PubMed Identifier
20307568
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.
Results Reference
result

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Interventions to Improve Colorectal Cancer Screening

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