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- Title
The effect of changing stool collection processes on compliance in nationwide organized screening using a fecal occult blood test (FOBT) in Korea: study protocol for a randomized controlled trial.
- Authors
Hye Young Shin; Mina Suh; Hyung Won Baik; Kui Son Choi; Boyoung Park; Jae Kwan Jun; Chan Wha Lee; Jae Hwan Oh; You Kyoung Lee; Dong Soo Han; Do-Hoon Lee
- Abstract
Background 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. The aim of this study is to investigate whether stool collection strategies affect compliance with the FOBT. Methods/Design In 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 x 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. Discussion Identifying 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.
- Subjects
COLON cancer treatment; FECAL occult blood tests; RANDOMIZED controlled trials; COLON cancer patients; FACTORIAL experiment designs; HEREDITARY nonpolyposis colorectal cancer
- Publication
Trials, 2014, Vol 15, Issue 1, p2
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/1745-6215-15-461