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. 2020 Apr 3;9(4):e16413.
doi: 10.2196/16413.

Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

Laura Fiona Gruner  1   2 , Michael Hoffmeister  1 , Leopold Ludwig  3 , Hermann Brenner  1   4   5
Affiliations

Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

Laura Fiona Gruner et al. JMIR Res Protoc. .

Abstract

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.

Keywords: Germany; colorectal cancer; early detection; fecal immunochemical test (FIT); invitation; screening.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Study design. Total expected fecal immunochemical test (FIT) use per study arm: A=35%, B=17.5%, and C=10%. Participants in arms A and B may receive a FIT as part of the intervention or can additionally request it in routine practice. Participants in arm C (ie, control) can only use the FIT in routine practice. Data on the use of screening methods until 1 year after the initial invitation will be collected. AOK BW: AOK Baden-Wuerttemberg; A1 and A2: subgroups of arm A; and B1 and B2: subgroups of arm B.
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