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.
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
  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 × 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.
  
  
  CONCLUSIONS
  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.
  KCT0000803 Date of registration in primary registry: 9 January, 2013.
authors.forename: Hye Young
authors.initials: HY
authors.lastname: Shin
authors.forename: Mina
authors.initials: M
authors.lastname: Suh
authors.forename: Hyung Won
authors.initials: HW
authors.lastname: Baik
authors.forename: Kui Son
authors.initials: KS
authors.lastname: Choi
authors.forename: Boyoung
authors.initials: B
authors.lastname: Park
authors.affiliation: National Cancer Control Institute, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, Gyeonggi-do 410-769, Republic of Korea. jkjun@ncc.re.kr.
authors.forename: Jae Kwan
authors.initials: JK
authors.lastname: Jun
authors.forename: Chan Wha
authors.initials: CW
authors.lastname: Lee
authors.forename: Jae Hwan
authors.initials: JH
authors.lastname: Oh
authors.forename: You Kyoung
authors.initials: YK
authors.lastname: Lee
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Han
authors.forename: Do-Hoon
authors.initials: DH
authors.lastname: Lee
mesh_terms: D000236:Adenoma / Q000175:diagnosis*; D000368:Aged; D002277:Carcinoma / Q000175:diagnosis*; D002985:Clinical Protocols; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033182:Intention; D008297:Male; D008875:Middle Aged; D009780:Occult Blood; D010349:Patient Compliance; D011237:Predictive Value of Tests; D056910:Republic of Korea; D012107:Research Design; D013048:Specimen Handling / Q000379:methods*