Improving Followup of Abnormal Colon Cancer Screening Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436137
Recruitment Status : Completed
First Posted : February 16, 2007
Last Update Posted : November 6, 2008
Brigham and Women's Hospital
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Patient mailing Not Applicable

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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Followup of Positive Fecal Occult Blood Tests
Study Start Date : June 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Performance of colonoscopy [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436137

United States, Massachusetts
Harvard Vanguard Medical Associates
Newton, Massachusetts, United States, 02466
Sponsors and Collaborators
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Principal Investigator: Thomas D Sequist, MD, MPH Harvard Vanguard Medical Associates

Responsible Party: Thomas Sequist, Brigham and Women's Hospital Identifier: NCT00436137     History of Changes
Other Study ID Numbers: Sequist Colorectal Cancer
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 2008

Keywords provided by Harvard Vanguard Medical Associates:
Colorectal cancer
Fecal occult blood test
Abnormal test result
Missed diagnosis
Delayed diagnosis

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases