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Improving Followup of Abnormal Colon Cancer Screening Tests

NCT ID: NCT00436137

Last Updated: 2008-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to determine whether direct mailings to patients with positive fecal occult blood tests can increase rates of performing followup colonoscopy.

Detailed Description

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Screening programs using the fecal occult blood test (FOBT) have demonstrated a significant reduction in colorectal cancer mortality, although only when accompanied by a complete diagnostic evaluation of the colon in the setting of a positive result. 90% of patients with a positive FOBT result have completed a subsequent colonoscopy within Harvard Vanguard Medical Associates. This project will use a pre-post study design to increase the rate of followup colonoscopy in the setting of positive FOBT results. Patients in the intervention group will receive a personalized mailing highlighting their positive result and need for colonoscopy, followed by telephone outreach from a centralized gastroenterology scheduling office. The primary outcome will be the performance of colonoscopy, however we will also perform chart reviews to identify predictors of completing appropriate followup.

Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer Fecal occult blood test Abnormal test result Missed diagnosis Delayed diagnosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach

Group Type EXPERIMENTAL

Patient mailing

Intervention Type BEHAVIORAL

Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

Interventions

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Patient mailing

Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with positive fecal occult blood test during 2004, 2005, and 2006; and no colonoscopy following this test result

Exclusion Criteria

* Patients with active cardiopulmonary disease or limited life expectancy due to severe illness such as malignancy
* Colonoscopy within 5 years prior to positive fecal occult blood test
* Age \> 80 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital

Principal Investigators

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Thomas D Sequist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Vanguard Medical Associates

Locations

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Harvard Vanguard Medical Associates

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Sequist Colorectal Cancer

Identifier Type: -

Identifier Source: org_study_id