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; Michael Hoffmeister; Leopold Ludwig; Hermann Brenner

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

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

Authors

Laura Fiona Gruner^{1

2}, Michael Hoffmeister¹, Leopold Ludwig³, Hermann Brenner^{1

4

5}

Affiliations

¹ Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany.
² Medical Faculty Heidelberg, University of Heidelberg, Heidelberg, Germany.
³ Gastroentereologische Schwerpunktpraxis, Dornstadt, Germany.
⁴ Division of Preventive Oncology, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany.
⁵ German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.

PMID: 32242518
PMCID: PMC7165303
DOI: 10.2196/16413

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.

©Laura Fiona Gruner, Michael Hoffmeister, Leopold Ludwig, Hermann Brenner. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.04.2020.