Improving Followup of Abnormal Colon Cancer Screening Tests

Colorectal Cancer Clinical Trial

Official title:

Improving Followup of Positive Fecal Occult Blood Tests

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436137
• Other study ID #: Sequist Colorectal Cancer
• Status: Completed
• Phase: N/A
• First received: February 14, 2007
• Last updated: November 5, 2008
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: November 2008
• Source: Harvard Vanguard Medical Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Newton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Vanguard Medical Associates	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of colonoscopy		6 months