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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00534053
First received: September 20, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 20, 2007
September 20, 2007
June 2007
Not Provided
Our primary outcome is FOBT card return rate [ Time Frame: 6 months ]
Same as current
No Changes Posted
Predictors of Non-compliance to fecal occult blood testing [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial
Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Colon Cancer
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.
  • Experimental: 1
    400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.
    Intervention: Other: Mailed Educational Reminder
  • No Intervention: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
October 2007
Not Provided

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
Both
50 Years and older
Yes
Contact: Jeffrey K Lee, B.A. 510-847-1198 jklee@ucsd.edu
United States
 
NCT00534053
070504
No
Not Provided
University of California, San Diego
Not Provided
Principal Investigator: Samuel B Ho, M.D. UCSD, VA San Diego
University of California, San Diego
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP