1. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer
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Brigitte Böhmer, Maximilian Bock, Birgit Richter, Kristina Schreiber, Werner Hartl, Adolf Ried, Daniela Pacini, Friedrich Lehner, Judith Maier, Gerhard Seiler, Axel Enhuber, Stephan Fritz, Ulrich Ihle, Gerd Kelly, Godehard Rutz, Bruno Ratter, Thomas Weisbarth, Klaus Michels, Raphael Weiβgerber, Viktor Damjantschitsch, Michael Braun, Christine Meier, Hans-Joachim Horn, Jens Kohlmeyer, Josef Käss, Maria Neef, Manfred Schöberl, Elke Kistner, Jürgen Hamberger, Gudrun Liebig-Hörl, Marie-Luise Vogel, Gerhard Wagner, Jürgen Reichold, Marc Zörerbauer, Hans-Jürgen Hackl, Ina Winter, Franz Mandlinger, Andreas Piberger, Magda van de Laar, Wolfgang Hiergeist, Georg Feldmer, Gernot Schindler, Florian Santner, Matthias Demandt, Vera-Maria Gohlke, Hubert Kleindienst, Gabriele Sostmeier, Stefan Semmler, Thomas Seubert, Bernd Graf, Rupert Hanrieder, Renate Woschée, Erwin Schierl, Jan Hendrik van de Berg, Franz Mohr, Sonja Hofmann, Elena Huber, Micheline Geldsetzer, Elvira Keller, Erich Simon, Julia Weigand, Florian Zeman, Bernd Wellhöfer, Hans Georg Haser, Markus Artner, Anton Peter, Martin Pfefferkorn, Michael Staab, Christine Wöll-Kobler, Reinhard Spreyer, C. Haberl, Roland Rischbeck, Roland Muggendorfer, Rudolf Männer, Gunter Lingner, Sandra Scheffczyk, Anita Walter, Alois Fürst, Tümmler Fred, Benedikt Lampl, Ulrike Kuhrt, Diethard Eibl, Petra Schwedmann, Frederik Mader, Franz Ehrnsperger, Anita Malterer, Olga Arzberger, Klaus Neumann, Johann Nusser, Elisabeth Sturm-Wittl, Konstantin Radi, Anna Schneider, Peter Perzl, Maria Putz, Jens Spaltmann, Erich Gruber, Vera Schnell, Julia Gumpp, Christoph Puchner, Anton Tkaczyk, Karin Germann-Bauer, Robert Weber, Hans Tylla, Helmut Müller, Thomas Bucher, Lisa Kuchler, Birgit Mühlenbruch, Klaus Kubitschek, Matthias Hartmann, Peter Klein, Michael Meinhardt, Patricia Lindberg-Scharf, Elisabeth Schweitzer, Michael Koller, Franz Walter, Hubert Wagner, Irmengard Begemann, Sandra Wegscheid, Karl Witzmann, Ulrike Röschl, Katrin Krauss, Carlos Diaz, Stefan Kobras, Anke Schlenska-Lange, Andrea Plank, Egid Mürbeth, Hans Peter Ferstl, Elvira Dommel, Christine Böttger, Ruth Zimmermann, Uwe Rauprich, Irene Walter, Veronika Peller, B. Steinger, Angelika Plank-Wihr, Vladimir Arcybasov, Andrea Kulig, Thomas Kestler, Thomas Langer, Marius Kleisch-Nicoara, Clemens Bonke, Franz Wolf, Johannes Jockel, Horst Kneiβl, Martin Ochsenkühn, Anca-Elena Pletl, Jessica Hentschel, Michaela Faltermeier, Gerold Haug, Joachim Feldner, Peter Eibl, Thomas Irmer, Elke Zankel, Verena Zahn, Barbara Meyer, Susanne Meyer, Norbert Buchmeier, Heike Nöller, Annegret Altendorfer, Christiane Heidrich, Tanja Zilch, Renate Peschke, Wido Wilke, Wolfgang Grampp, Michael Riβmann, Monika Brunner, Manfred Kästel, Verena Engelbrecht, Hans-Jürgen Füßl, Michael Geisler, Josef Kindler, Bernhard Kiefmann, Georg Schwindl, Carl Rauscher, Mark Hauer, Rafael Piazolo, Bernhard Schönhärl, Herbert Platzer, Wolfgang Kraus, Siegfried Gehrmann, Ralf Kecke, Heiko Rieder, Georg Preininger, Wolfgang Bräutigam, Monika Klinkhammer-Schalke, Andrea Wonka, Ralf Hauer, Erwin Bambl, Johannes Wolf, Thomas Leibig, Richard Wagner, Thomas Fuchs, Wolfgang Sinzker, Petra Lütz, Claus Schäfer, Alois Kuhn, Martin Bauer, Heinrich Dickert, Bernhard Grumbeck, Norbert Bloos, Daniela Cameron, Thomas Harloff, Bruno Brandscherdt, Christina Apel, Barbara Schutt, Simone Steinbild, Christian Spieβl, Georg Sedlmayer, Pompiliu Piso, Marion Brunner, Peter Voigtländer, Ralf Marx, Sonja Leeb, Daniel Bulling, Thomas Hinrichs, Angela Tautrim, Hans Kehrer, Axel Selchert, Birgit Pelz-Knöbl, Richard Franzke, Karl Lehmeyer, Andreas Müller, Robert Franz, Robert Pavlik, Robert Obermaier, Catarina Stosiek, and Morgens Heusinger
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Male ,0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,Colorectal cancer ,Population ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Randomized controlled trial ,Quality of life ,law ,Surveys and Questionnaires ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Single-Blind Method ,Prospective Studies ,education ,Aged ,education.field_of_study ,business.industry ,Cancer ,medicine.disease ,humanities ,Clinical trial ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Quality of Life ,Female ,Colorectal Neoplasms ,business - 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.
- Published
- 2020