Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Other: Mailed Educational Reminder

• Registration Number: NCT00534053
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase fecal occult blood test (FOBT) card return rates and, therefore, improve patient compliance with colonrectal cancer (CRC) screening.

We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to FOBT referrals is at least 10% greater among patients who receive mailed educational reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs Medical Center and surrounding VA clinics in San Diego.

Detailed Description

Colorectal cancer (CRC) is the third most common cancer in men and women in the United States with an estimated 147,000 new cases and more than 56,000 deaths each year. Early detection of colon cancer and removal of precancerous adenomatous polyps have been shown to reduce its morbidity, mortality and incidence. There are several recommended CRC screening tests, including fecal occult blood test (FOBT), flexible sigmoidoscopy, air-contrast barium enema, and colonoscopy. In the VA, FOBT is the predominant screening test for CRC, however patient compliance is low. Numerous studies have evaluated patient participation in CRC screening programs and FOBT card return rates, all of which have shown patient adherence was suboptimal. To date, there are no studies that have evaluated whether mailed educational reminders can improve FOBT compliance. The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase FOBT card return rates and, therefore, improve patient compliance with CRC screening.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 775

Inclusion Criteria

• asymptomatic men and women age 50 years or older who received screening FOBT card kits from the laboratory

Exclusion Criteria

• are less than 50 years of age
• are inpatients
• are not undergoing routine colon cancer screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Mailed Educational Reminder	400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.

Primary Outcome Measures

Name	Time	Method
Our primary outcome is FOBT card return rate	6 months

Secondary Outcome Measures

Name	Time	Method
Predictors of Non-compliance to fecal occult blood testing	6 months

Trial Locations

Locations (1)

Veteran Affairs Medical Center San Diego; 🇺🇸 San Diego, California, United States