Improving Followup of Abnormal Colon Cancer Screening Tests
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient mailing
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring Colorectal cancer, Fecal occult blood test, Abnormal test result, Missed diagnosis, Delayed diagnosis
Eligibility 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
Sites / Locations
- Harvard Vanguard Medical Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach
Outcomes
Primary Outcome Measures
Performance of colonoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT00436137
First Posted
February 14, 2007
Last Updated
November 5, 2008
Sponsor
Harvard Vanguard Medical Associates
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00436137
Brief Title
Improving Followup of Abnormal Colon Cancer Screening Tests
Official Title
Improving Followup of Positive Fecal Occult Blood Tests
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harvard Vanguard Medical Associates
Collaborators
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Fecal occult blood test, Abnormal test result, Missed diagnosis, Delayed diagnosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive a mailing recommending colonoscopy, followed by a telephone outreach
Intervention Type
Behavioral
Intervention Name(s)
Patient mailing
Intervention Description
Patient will receive a mailing recommending colonoscopy, followed by telephone outreach
Primary Outcome Measure Information:
Title
Performance of colonoscopy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D Sequist, MD, MPH
Organizational Affiliation
Harvard Vanguard Medical Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Vanguard Medical Associates
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02466
Country
United States
12. IPD Sharing Statement
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Improving Followup of Abnormal Colon Cancer Screening Tests
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