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临床试验/NCT00692211
NCT00692211已完成不适用

Interventions to Improve Colorectal Cancer Screening Rates and Adherence

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
404
试验地点
2
主要终点
Colorectal Cancer Screening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for stool-based colorectal cancer screening, followed in primary care clinic

排除标准

  • Need for surveillance or screening colonoscopy
  • limited life expectancy

结局指标

主要结局

Colorectal Cancer Screening

时间窗: 3 months

Completing fecal blood test within 90 days of enrolling

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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