Study protocol for a randomized controlled multinational trial to analyze the effects of an app-based patient education textbook (Ready4OP App) to increase health literacy before major oncologic surgery and its potential effects on surgical outcomes

Abstract Background Low levels of health literacy (HL) are associated with worse health outcomes and increased mortality. Surgery is among the top three risks of dying in a hospital worldwide. An improvement in health literacy is known to be associated with better healthcare outcomes. To date, there is no data available, on whether a learning instrument can improve health literacy in surgical oncologic patients or if it influences short-term surgical outcomes. Methods The APERIO trial is a multicenter prospective randomized controlled trial comparing a digital app-based preparation platform with the hospitals’ standard care. The trial seeks to enroll 382 patients in three different countries who will be randomized in either the intervention or the control group. The primary objective is to evaluate the efficacy of the Ready4OP app in improving health literacy in surgical oncologic patients. The secondary endpoints are investigating 90-day mortality rates, compliance, and adherence to Ready4OP as a digital learning platform, to increase equality of cancer patients’ health literacy in three different European countries and to evaluate the influence of an app-based educational platform on surgical oncologic short-term outcomes and morbidity. Discussion We form the hypothesis that providing a digital app-based preparation platform for patients before major surgical oncologic procedures will reduce the number of badly informed patients from 60 to 45% as measured by standardized questionnaires. Therefore, the APERIO trial aims to evaluate the efficacy of the Ready4OP app in improving health literacy in surgical oncologic patients. Trial registration Trial registered in the German Clinical Trial Registry (DRKS00031507, Registered on May 22 2023), Goethe University Ethics approval 09.05.2023 (2023-1173).