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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Other: Mailed Educational Reminder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>|
| No Intervention: 2<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our primary outcome is FOBT card return rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of Non-compliance to fecal occult blood testing |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer screening, mail reminders, fecal occult blood test, compliance