Abstract
BackgroundColorectal cancer (CRC) screening by fecal occult blood test (FOBT) significantly reduces CRC mortality, and compliance rates directly influence the efficacy of this screening method. The aim of this study is to investigate whether stool collection strategies affect compliance with the FOBT.Methods/DesignIn total, 3,596 study participants aged between 50 and 74 years will be recruited. The study will be conducted using a randomized controlled trial, with a 2 × 2 factorial design resulting in four groups. The first factor is the method of stool-collection device distribution (mailing vs. visiting the clinic) and the second is the type of stool-collection device (sampling kit vs. conventional container). Participants will be randomly assigned to one of four groups: (1) sampling kit received by mail; (2) conventional container received by mail; (3) sampling kit received at the clinic; (4) conventional container received at the clinic (control group). The primary outcome will be the FOBT compliance rate; satisfaction and intention to be rescreened in the next screening round will also be evaluated. The rates of positive FOBT results and detection of advanced adenomas or cancers through colonoscopies will also be compared between the two collection containers.DiscussionIdentifying a method of FOBT that yields high compliance rates will be a key determinant of the success of CRC screening. The findings of this study will provide reliable information for health policy makers to develop evidence-based strategies for a high compliance rate.Trial registrationCRIS:KCT0000803Date of registration in primary registry: 9 January, 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-461) contains supplementary material, which is available to authorized users.
Highlights
Colorectal cancer (CRC) screening by fecal occult blood test (FOBT) significantly reduces CRC mortality, and compliance rates directly influence the efficacy of this screening method
Identifying a method of FOBT that yields high compliance rates will be a key determinant of the success of CRC screening
The study will be composed of four groups from two factors: (1) sampling kit received by mail; (2) conventional container received by mail; (3) sampling kit received at the clinic; (4) conventional container received at the clinic (Figure 1)
Summary
Colorectal cancer (CRC) screening by fecal occult blood test (FOBT) significantly reduces CRC mortality, and compliance rates directly influence the efficacy of this screening method. In Korea, the system-related barriers to an efficient screening process have been reported to be the requirement for two consecutive clinic visits to receive the stool device and submit the sample, and the use of a stool container that has a short, thick sampling probe to collect stool samples [17]. The second is to provide a stool sampling kit consisting of a small test tube including a longer, thinner sampling probe that is easier to poke into the stool to collect stool specimens Through these interventions, this study will determine the most effective strategy to increase compliance and satisfaction in FOBT screening. We will compare the rates of positive FOBT results between the two stool devices to validate our assumptions
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