Improving Followup of Abnormal Colon Cancer Screening Tests

November 5, 2008 updated by: Harvard Vanguard Medical Associates

Improving Followup of Positive Fecal Occult Blood Tests

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02466
        • Harvard Vanguard Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach
Behavioral: Patient mailing
Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance of colonoscopy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Vanguard Medical Associates

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Thomas D Sequist, MD, MPH, Harvard Vanguard Medical Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2008

Last Update Submitted That Met QC Criteria

November 5, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sequist Colorectal Cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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