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Improving Followup of Abnormal Colon Cancer Screening Tests

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436137
First Posted: February 16, 2007
Last Update Posted: November 6, 2008
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.
Collaborator:
Brigham and Women's Hospital
Information provided by:
Harvard Vanguard Medical Associates
  Purpose
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 Intervention
Colorectal Cancer Behavioral: Patient mailing

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Harvard Vanguard Medical Associates:

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

Enrollment: 70
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00436137


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

Responsible Party: Thomas Sequist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00436137     History of Changes
Other Study ID Numbers: Sequist Colorectal Cancer
First Submitted: February 14, 2007
First Posted: February 16, 2007
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases