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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.
See this image and copyright information in PMC

References

    1. Shaukat A, Mongin SJ, Geisser MS, Lederle FA, Bond JH, Mandel JS, Church TR. Long-term mortality after screening for colorectal cancer. N Engl J Med. 2013 Sep 19;369(12):1106–1114. doi: 10.1056/NEJMoa1300720. - DOI - PubMed
    1. European Colorectal Cancer Screening Guidelines Working Group. von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinàs JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Mádai S, Marinho J, Maučec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Törnberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: Overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51–59. doi: 10.1055/s-0032-1325997. http://www.thieme-connect.com/DOI/DOI?10.1055/s-0032-1325997 - DOI - PMC - PubMed
    1. Gemeinsamer Bundesausschuss Richtlinie des Gemeinsamen Bundesausschusses für organisierte Krebsfrüherkennungsprogramme. 2019. Jul, [2019-07-05]. https://www.g-ba.de/downloads/62-492-1844/oKFE-RL-2018-11-22-iK-2019-07-....
    1. Lopes G, Stern MC, Temin S, Sharara AI, Cervantes A, Costas-Chavarri A, Engineer R, Hamashima C, Ho GF, Huitzil FD, Moghani MM, Nandakumar G, Shah MA, Teh C, Manjarrez SE, Verjee A, Yantiss R, Correa MC. Early detection for colorectal cancer: ASCO resource-stratified guideline. J Glob Oncol. 2019 Feb;5:1–22. doi: 10.1200/JGO.18.00213. http://europepmc.org/abstract/MED/30802159 - DOI - PMC - PubMed
    1. Schreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: A global overview of existing programmes. Gut. 2015 Oct;64(10):1637–1649. doi: 10.1136/gutjnl-2014-309086. - DOI - PubMed

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