Improving Followup of Abnormal Colon Cancer Screening Tests

Improving Followup of Positive Fecal Occult Blood Tests

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00436137

Enrollment

Registered

2007-02-16

Start date

2007-06-30

Completion date

2008-03-31

Last updated

2008-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Fecal occult blood test, Abnormal test result, Missed diagnosis, Delayed diagnosis

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.

Interventions

BEHAVIORALPatient mailing

Patient will receive a mailing recommending colonoscopy, followed by telephone outreach

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Performance of colonoscopy	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026