Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer
Monika Klinkhammer-Schalke, Brunhilde Steinger, Michael Koller, Florian Zeman, Alois Fürst, Julia Gumpp, Robert Obermaier, Pompiliu Piso, Patricia Lindberg-Scharf, Regensburg QoL Study Group, Annegret Altendorfer, Christina Apel, Vladimir Arcybasov, Markus Artner, Olga Arzberger, Erwin Bambl, Martin Bauer, Irmengard Begemann, Norbert Bloos, Maximilian Bock, Brigitte Böhmer, Clemens Bonke, Christine Böttger, Bruno Brandscherdt, Michael Braun, Wolfgang Bräutigam, Marion Brunner, Monika Brunner, Thomas Bucher, Norbert Buchmeier, Daniel Bulling, Daniela Cameron, Viktor Damjantschitsch, Matthias Demandt, Carlos Diaz, Heinrich Dickert, Elvira Dommel, Franz Ehrnsperger, Diethard Eibl, Peter Eibl, Verena Engelbrecht, Axel Enhuber, Michaela Faltermeier, Georg Feldmer, Joachim Feldner, Hans Peter Ferstl, Robert Franz, Richard Franzke, Stephan Fritz, Thomas Fuchs, Hans-Jürgen Füßl, Siegfried Gehrmann, Michael Geisler, Micheline Geldsetzer, Karin Germann-Bauer, Vera-Maria Gohlke, Bernd Graf, Wolfgang Grampp, Erich Gruber, Bernhard Grumbeck, Christopher Haberl, Hans-Jürgen Hackl, Jürgen Hamberger, Rupert Hanrieder, Thomas Harloff, Werner Hartl, Matthias Hartmann, Hans Georg Haser, Mark Hauer, Ralf Hauer, Gerold Haug, Christiane Heidrich, Jessica Hentschel, Morgens Heusinger, Wolfgang Hiergeist, Thomas Hinrichs, Sonja Hofmann, Hans-Joachim Horn, Elena Huber, Ulrich Ihle, Thomas Irmer, Johannes Jockel, Josef Käss, Manfred Kästel, Ralf Kecke, Hans Kehrer, Elvira Keller, Gerd Kelly, Thomas Kestler, Bernhard Kiefmann, Josef Kindler, Elke Kistner, Peter Klein, Hubert Kleindienst, Marius Kleisch-Nicoara, Horst Kneiβl, Stefan Kobras, Jens Kohlmeyer, Wolfgang Kraus, Katrin Krauss, Klaus Kubitschek, Lisa Kuchler, Alois Kuhn, Ulrike Kuhrt, Andrea Kulig, Magda van de Laar, Benedikt Lampl, Thomas Langer, Sonja Leeb, Karl Lehmeyer, Friedrich Lehner, Thomas Leibig, Gudrun Liebig-Hörl, Gunter Lingner, Petra Lütz, Frederik Mader, Judith Maier, Anita Malterer, Franz Mandlinger, Rudolf Männer, Ralf Marx, Christine Meier, Michael Meinhardt, Barbara Meyer, Susanne Meyer, Klaus Michels, Franz Mohr, Roland Muggendorfer, Birgit Mühlenbruch, Andreas Müller, Helmut Müller, Egid Mürbeth, Maria Neef, Klaus Neumann, Heike Nöller, Johann Nusser, Martin Ochsenkühn, Daniela Pacini, Robert Pavlik, Veronika Peller, Birgit Pelz-Knöbl, Peter Perzl, Renate Peschke, Anton Peter, Martin Pfefferkorn, Rafael Piazolo, Andreas Piberger, Andrea Plank, Angelika Plank-Wihr, Herbert Platzer, Anca-Elena Pletl, Georg Preininger, Christoph Puchner, Maria Putz, Konstantin Radi, Bruno Ratter, Uwe Rauprich, Carl Rauscher, Jürgen Reichold, Birgit Richter, Adolf Ried, Heiko Rieder, Roland Rischbeck, Michael Riβmann, Ulrike Röschl, Godehard Rutz, Florian Santner, Claus Schäfer, Sandra Scheffczyk, Erwin Schierl, Gernot Schindler, Anke Schlenska-Lange, Anna Schneider, Vera Schnell, Manfred Schöberl, Bernhard Schönhärl, Kristina Schreiber, Barbara Schutt, Petra Schwedmann, Elisabeth Schweitzer, Georg Schwindl, Georg Sedlmayer, Gerhard Seiler, Axel Selchert, Stefan Semmler, Thomas Seubert, Erich Simon, Wolfgang Sinzker, Gabriele Sostmeier, Jens Spaltmann, Christian Spieβl, Reinhard Spreyer, Michael Staab, Simone Steinbild, Catarina Stosiek, Elisabeth Sturm-Wittl, Angela Tautrim, Anton Tkaczyk, Tümmler Fred, Hans Tylla, Jan Hendrik van de Berg, Marie-Luise Vogel, Peter Voigtländer, Gerhard Wagner, Hubert Wagner, Richard Wagner, Anita Walter, Franz Walter, Irene Walter, Robert Weber, Sandra Wegscheid, Julia Weigand, Thomas Weisbarth, Raphael Weiβgerber, Bernd Wellhöfer, Wido Wilke, Ina Winter, Karl Witzmann, Franz Wolf, Johannes Wolf, Christine Wöll-Kobler, Andrea Wonka, Renate Woschée, Verena Zahn, Elke Zankel, Tanja Zilch, Ruth Zimmermann, Marc Zörerbauer, Monika Klinkhammer-Schalke, Brunhilde Steinger, Michael Koller, Florian Zeman, Alois Fürst, Julia Gumpp, Robert Obermaier, Pompiliu Piso, Patricia Lindberg-Scharf, Regensburg QoL Study Group, Annegret Altendorfer, Christina Apel, Vladimir Arcybasov, Markus Artner, Olga Arzberger, Erwin Bambl, Martin Bauer, Irmengard Begemann, Norbert Bloos, Maximilian Bock, Brigitte Böhmer, Clemens Bonke, Christine Böttger, Bruno Brandscherdt, Michael Braun, Wolfgang Bräutigam, Marion Brunner, Monika Brunner, Thomas Bucher, Norbert Buchmeier, Daniel Bulling, Daniela Cameron, Viktor Damjantschitsch, Matthias Demandt, Carlos Diaz, Heinrich Dickert, Elvira Dommel, Franz Ehrnsperger, Diethard Eibl, Peter Eibl, Verena Engelbrecht, Axel Enhuber, Michaela Faltermeier, Georg Feldmer, Joachim Feldner, Hans Peter Ferstl, Robert Franz, Richard Franzke, Stephan Fritz, Thomas Fuchs, Hans-Jürgen Füßl, Siegfried Gehrmann, Michael Geisler, Micheline Geldsetzer, Karin Germann-Bauer, Vera-Maria Gohlke, Bernd Graf, Wolfgang Grampp, Erich Gruber, Bernhard Grumbeck, Christopher Haberl, Hans-Jürgen Hackl, Jürgen Hamberger, Rupert Hanrieder, Thomas Harloff, Werner Hartl, Matthias Hartmann, Hans Georg Haser, Mark Hauer, Ralf Hauer, Gerold Haug, Christiane Heidrich, Jessica Hentschel, Morgens Heusinger, Wolfgang Hiergeist, Thomas Hinrichs, Sonja Hofmann, Hans-Joachim Horn, Elena Huber, Ulrich Ihle, Thomas Irmer, Johannes Jockel, Josef Käss, Manfred Kästel, Ralf Kecke, Hans Kehrer, Elvira Keller, Gerd Kelly, Thomas Kestler, Bernhard Kiefmann, Josef Kindler, Elke Kistner, Peter Klein, Hubert Kleindienst, Marius Kleisch-Nicoara, Horst Kneiβl, Stefan Kobras, Jens Kohlmeyer, Wolfgang Kraus, Katrin Krauss, Klaus Kubitschek, Lisa Kuchler, Alois Kuhn, Ulrike Kuhrt, Andrea Kulig, Magda van de Laar, Benedikt Lampl, Thomas Langer, Sonja Leeb, Karl Lehmeyer, Friedrich Lehner, Thomas Leibig, Gudrun Liebig-Hörl, Gunter Lingner, Petra Lütz, Frederik Mader, Judith Maier, Anita Malterer, Franz Mandlinger, Rudolf Männer, Ralf Marx, Christine Meier, Michael Meinhardt, Barbara Meyer, Susanne Meyer, Klaus Michels, Franz Mohr, Roland Muggendorfer, Birgit Mühlenbruch, Andreas Müller, Helmut Müller, Egid Mürbeth, Maria Neef, Klaus Neumann, Heike Nöller, Johann Nusser, Martin Ochsenkühn, Daniela Pacini, Robert Pavlik, Veronika Peller, Birgit Pelz-Knöbl, Peter Perzl, Renate Peschke, Anton Peter, Martin Pfefferkorn, Rafael Piazolo, Andreas Piberger, Andrea Plank, Angelika Plank-Wihr, Herbert Platzer, Anca-Elena Pletl, Georg Preininger, Christoph Puchner, Maria Putz, Konstantin Radi, Bruno Ratter, Uwe Rauprich, Carl Rauscher, Jürgen Reichold, Birgit Richter, Adolf Ried, Heiko Rieder, Roland Rischbeck, Michael Riβmann, Ulrike Röschl, Godehard Rutz, Florian Santner, Claus Schäfer, Sandra Scheffczyk, Erwin Schierl, Gernot Schindler, Anke Schlenska-Lange, Anna Schneider, Vera Schnell, Manfred Schöberl, Bernhard Schönhärl, Kristina Schreiber, Barbara Schutt, Petra Schwedmann, Elisabeth Schweitzer, Georg Schwindl, Georg Sedlmayer, Gerhard Seiler, Axel Selchert, Stefan Semmler, Thomas Seubert, Erich Simon, Wolfgang Sinzker, Gabriele Sostmeier, Jens Spaltmann, Christian Spieβl, Reinhard Spreyer, Michael Staab, Simone Steinbild, Catarina Stosiek, Elisabeth Sturm-Wittl, Angela Tautrim, Anton Tkaczyk, Tümmler Fred, Hans Tylla, Jan Hendrik van de Berg, Marie-Luise Vogel, Peter Voigtländer, Gerhard Wagner, Hubert Wagner, Richard Wagner, Anita Walter, Franz Walter, Irene Walter, Robert Weber, Sandra Wegscheid, Julia Weigand, Thomas Weisbarth, Raphael Weiβgerber, Bernd Wellhöfer, Wido Wilke, Ina Winter, Karl Witzmann, Franz Wolf, Johannes Wolf, Christine Wöll-Kobler, Andrea Wonka, Renate Woschée, Verena Zahn, Elke Zankel, Tanja Zilch, Ruth Zimmermann, Marc Zörerbauer
Abstract
Background: The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer.
Methods: This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual.
Findings: Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31-54%) in the intervention group versus 50/87 (57%; 95% CI: 46-68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3-225).
Interpretation: Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care.
Funding: Federal Ministry of Education and Research (BMBF; grant no. 01GY1339).
Clinical trial information: NCT02321813.
Keywords: Colorectal cancer; Complex intervention; Definitive RCT; Effectiveness of quality of life implementation; Quality of life.
Conflict of interest statement
Conflict of interest statement We declare no competing interests.
Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Source: PubMed