Improving Followup of Abnormal Colon Cancer Screening Tests

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Patient mailing

• Registration Number: NCT00436137
• Lead Sponsor: Harvard Vanguard Medical Associates

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-16
• Study Start: 2007-06
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-05
• Last Update Posted: 2008-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Patient mailing	Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach

Primary Outcome Measures

Name	Time	Method
Performance of colonoscopy	6 months

Trial Locations

Locations (1)

Harvard Vanguard Medical Associates; 🇺🇸 Newton, Massachusetts, United States