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Effectiveness of a standardized patient education program on therapy-related side effects and unplanned therapy interruptions in oral cancer therapy: a cluster-randomized controlled trial



Oral agents for cancer treatment are increasingly prescribed due to their benefits. However, oral cancer medications are difficult to handle and have a considerable potential for side effects. This type of therapy requires a high level of self-management competence by the patient. A standardized patient education program provided by physicians and oncology nurses may positively influence the handling of oral agents. The aim of the study was to evaluate the impact of a standardized patient education program provided by specially trained oncology nurses on therapy management regarding side effects and unplanned therapy interruptions.


One hundred sixty-five patients from 28 office-based oncology practices from all over Germany participated in this cluster-randomized controlled study. Patients of both intervention (n = 111) and standard care groups (n = 54) received the usual oncologist counseling; in addition, the patients from the intervention group (k = 17 practices) received an education from specially trained oncology nurses. The time of observation was 3 months per patient.


The patients of the intervention group reported fewer side effects (skin rash, pain, fatigue, nausea, vomiting). Patients in the standard care group interrupted the therapy more frequently without informing their oncologist, compared to the intervention group.


Patients benefit from a standardized patient education program provided by specially trained oncology nurses. They tend to handle side effects and critical situations better.

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This research was funded by the German Federal Ministry of Health within the National Cancer Plan. We give special thanks to Klaus Becker, Patricia Bernhardt, Mathias Bertram, Hans Peter Böck, Maria Borrmann, Anita Breninek, Andrea Cazan, Hans Wilhelm Dübbers, Michael Eckart, Peter Ehscheidt, Ulrike Eichhorn, Alexandra Elflein, Till Oliver Emde, Birgit Euchenhofer, Regina Fey, Astrid Flöte, Werner Freier, Roswitha Fuchs, Stefanie Gawel, Thomas Hamm, Richard Hansen, Stefanie Heidtmann, Melanie Heinz, Anja Herbst, Alexandra Hesse, Jochen Heymanns, Ulrich Hutzschenreuter, Georg Jacobs, Semra Jäckel, Elke Janning, Sabine Kirchhoff, Nicole Kissel, Astrid Klein, Nicole Kratzer, Tanja Kreuzpaintner, Andrea Kretz, Carmen Lenz, Anja Liesegang, Albrecht Lindemann, Enno Moorahrend, Lothar Müller, Monika Müller, Constanze Priebe-Richter, Margret Rebmann-Albes, Tobias Reiber, Antje Reschke, Daniel Reschke, Annette Sauer, Michael Schauer, Susann Schleife, Stephan Schmitz, Ina Schoon, Monika Spanger, Jan Schröder, Petra Schwedhelm, Eveline Siegel, Daria Tisch, Eva Völkel, Dorothee Volgmann, Thomas Walawgo, Maria Weber, Monika Weiler, Linda Werner, Jochen Wilke, Merle Willam, Sarah Wolff, Mark-Oliver Zahn, and Pablo Zamora.

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Riese, C., Weiß, B., Borges, U. et al. Effectiveness of a standardized patient education program on therapy-related side effects and unplanned therapy interruptions in oral cancer therapy: a cluster-randomized controlled trial. Support Care Cancer 25, 3475–3483 (2017).

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  • Oral cancer therapy
  • Patient education
  • Oncology nurses
  • Therapy-related side effects
  • Unplanned therapy interruption