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

NCT ID: NCT00534053

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 775 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

1

400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.

Group Type: EXPERIMENTAL

Mailed Educational Reminder

Intervention Type: OTHER

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.

2

400 patients will not receive a mailed educational reminder to return their FOBT cards after they have picked up the FOBT cards from the VA laboratory

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel B Ho, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD, VA San Diego

Locations

Veteran Affairs Medical Center San Diego

San Diego, California, United States

Countries

United States

References

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. doi: 10.1111/j.1525-1497.2005.40023.x.

Reference Type: BACKGROUND

PMID: 15836533 (View on PubMed)

Lee JK, Reis V, Liu S, Conn L, Groessl EJ, Ganiats TG, Ho SB. Improving fecal occult blood testing compliance using a mailed educational reminder. J Gen Intern Med. 2009 Nov;24(11):1192-7. doi: 10.1007/s11606-009-1087-5. Epub 2009 Sep 23.

Reference Type: DERIVED

PMID: 19774423 (View on PubMed)

Other Identifiers

070504

Identifier Type: -

Identifier Source: org_study_id