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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
  Purpose

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.


Condition Intervention
Colon Cancer
 Other: Mailed Educational Reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Our primary outcome is FOBT card return rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Predictors of Non-compliance to fecal occult blood testing [ Time Frame: 6 months ]

Estimated Enrollment: 800
Study Start Date: June 2007
Estimated Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.
 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.
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534053

Contacts
Contact: Jeffrey K Lee, B.A. 510-847-1198 jklee@ucsd.edu

Locations
United States, California
Veteran Affairs Medical Center San Diego Recruiting
San Diego, California, United States, 92161
Principal Investigator: Samuel B Ho, M.D.            
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Samuel B Ho, M.D. UCSD, VA San Diego
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00534053     History of Changes
Other Study ID Numbers: 070504
Study First Received: September 20, 2007
Last Updated: September 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
colon cancer screening
mail reminders
fecal occult blood test
compliance

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013