Improving Followup of Abnormal Colon Cancer Screening Tests
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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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Followup of Positive Fecal Occult Blood Tests |
- 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Massachusetts | |
| Harvard Vanguard Medical Associates | |
| Newton, Massachusetts, United States, 02466 | |
| Principal Investigator: | Thomas D Sequist, MD, MPH | Harvard Vanguard Medical Associates |
More Information
No publications provided
| Responsible Party: | Thomas Sequist, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00436137 History of Changes |
| Other Study ID Numbers: | Sequist Colorectal Cancer |
| Study First Received: | February 14, 2007 |
| Last Updated: | November 5, 2008 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on June 17, 2013