%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 9
%N 4
%P e16413
%T Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial
%A Gruner,Laura Fiona
%A Hoffmeister,Michael
%A Ludwig,Leopold
%A Brenner,Hermann
%+ Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Im Neuenheimer Feld 581, Heidelberg, 69120, Germany, 49 6221 42 1300, h.brenner@dkfz.de
%K colorectal cancer
%K early detection
%K screening
%K fecal immunochemical test (FIT)
%K invitation
%K Germany
%D 2020
%7 3.4.2020
%9 Protocol
%J JMIR Res Protoc
%G English
%X Background: Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low. Objective: The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years. Methods: This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy. Results: A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany—AOK Baden-Wuerttemberg—were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019. Conclusions: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. Trial Registration: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt International Registered Report Identifier (IRRID): DERR1-10.2196/16413 
%M 32242518
%R 10.2196/16413
%U https://www.researchprotocols.org/2020/4/e16413
%U https://doi.org/10.2196/16413
%U http://www.ncbi.nlm.nih.gov/pubmed/32242518