An interventional study of Mailed Educational Reminder in Colon Cancer, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Screening
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 775 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.
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Exclusion Criteria:
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
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
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.
Our primary outcome is FOBT card return rate
Time frame: 6 months
Predictors of Non-compliance to fecal occult blood testing
Time frame: 6 months
Ran from Jun 2007 to primary completion in Dec 2009, 30 months.
Of 290 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 60. This study's 30 months is close to that.
Counting every sponsor, half of 300 studies reached it within 32 months; a quarter within 18 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego →