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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534053
• Other study ID #: 070504
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 775
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• Mailed Educational Reminder
1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.

Locations

Country	Name	City	State
United States	Veteran Affairs Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stokamer CL, Tenner CT, Chaudhuri J, Vazquez E, Bini EJ. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med. 2005 Mar;20(3):278-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary outcome is FOBT card return rate		6 months
Secondary	Predictors of Non-compliance to fecal occult blood testing		6 months