BMJ Open (Jan 2020)
Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol
- Stephanie Stock,
- Martin Hellmich,
- Jörg-Christian Tonn,
- Lukas Radbruch,
- Niklas Thon,
- Claudia Bausewein,
- Stefanie Hamacher,
- Heidrun Golla,
- Charlotte Nettekoven,
- Berend Feddersen,
- Oliver Schnell,
- Christopher Böhlke,
- Gerhild Becker,
- Roman Rolke,
- Hans Clusmann,
- Ulrich Herrlinger,
- Hartmut Vatter,
- Erdem Güresir,
- Dirk Müller,
- Daniele Civello,
- Irini Papachristou,
- Raymond Voltz,
- Roland Goldbrunner,
- Imke Bronger,
- Kerstin Dederichs,
- Hildegard Cavelius,
- Sonja Hiddemann,
- Norbert Krumm,
- Christina Thamm,
- Daniel Delev,
- Marita Kumschlies,
- Manuela Langheimer,
- Chuh-Hyoun Na,
- Christiane Landwehr,
- Niklas Schäfer,
- Christina Schaub,
- Claudia Stratmann,
- Kirsten Hüning,
- Birgit Jaspers,
- Michaela Hesse,
- Isabel Franke,
- Melanie Joshi,
- Simone Matte,
- Lena Dreher,
- Gina Fürtjes,
- Sophia Kochs,
- Moritz Lenschow,
- Patrick Melich,
- Catharina Schröter,
- Bianca-Ioana Blaß,
- Debora Cipriani,
- Dieter Henrik Heiland,
- Pamela Heiland,
- Nadja Jarc,
- Nicole Koch,
- Marcia Regina Machein,
- Nicolas Neidert,
- Mateo Farina Nunez,
- Jolanda Daniuk,
- Bianca Lauble,
- Tina Meer,
- Saskia Opitz,
- Birgit Haberland,
- Eva Lehmann,
- Karla Steinberger,
- Sabine Streitwieser,
- Christoph Barth,
- Stefanie Lietke,
- Christiane Zimmerer
Affiliations
- Stephanie Stock
- Institute for Health Economics and Clinical Epidemiology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
- Martin Hellmich
- 3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
- Jörg-Christian Tonn
- 4 Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany
- Lukas Radbruch
- 11 Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany
- Niklas Thon
- 4 Department of Neurosurgery, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany
- Claudia Bausewein
- Department of Palliative Medicine, University Hospital, LMU Munich, Munich, Germany
- Stefanie Hamacher
- Faculty of Medicine and University Hospital, Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany
- Heidrun Golla
- 6 Department of Palliative Medicine, University Hospital Cologne, Cologne, Germany
- Charlotte Nettekoven
- 1 Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany
- Berend Feddersen
- 3 Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Munich (LMU), Munich, Germany
- Oliver Schnell
- professor
- Christopher Böhlke
- 6 Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Freiburg, Freiburg, Germany
- Gerhild Becker
- Department of Palliative Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
- Roman Rolke
- 7 Department of Palliative Medicine, Faculty of Medicine and University Hospital, RWTH Aachen University, Aachen, Germany
- Hans Clusmann
- Department of Neurosurgery, RWTH Aachen University Hospital Aachen, Aachen, Germany
- Ulrich Herrlinger
- 10 Division of Clinical Neurooncology, Department of Neurology, Faculty of Medicine and University Hospital, University of Bonn, Bonn, Germany
- Hartmut Vatter
- 8 Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany
- Erdem Güresir
- 8 Faculty of Medicine and University Hospital, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), University of Cologne, Cologne, Germany
- Dirk Müller
- Institute for Health Economics and Clinical Epidemiology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
- Daniele Civello
- 13 Faculty of Medicine and University Hospital, Institute for Health Economics and Clinical Epidemiology (IGKE), University of Cologne, Cologne, Germany
- Irini Papachristou
- 14 Faculty of Medicine and University Hospital, Center for Clinical Studies (ZKS), University of Cologne, Cologne, Germany
- Raymond Voltz
- Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany
- Roland Goldbrunner
- 2 Department of General Neurosurgery, Faculty of Medicine and University Hospital, Center for Neurosurgery, University of Cologne, Cologne, Germany
- Imke Bronger
- Kerstin Dederichs
- Hildegard Cavelius
- Sonja Hiddemann
- Norbert Krumm
- Christina Thamm
- Daniel Delev
- Marita Kumschlies
- Manuela Langheimer
- Chuh-Hyoun Na
- Christiane Landwehr
- Niklas Schäfer
- Christina Schaub
- Claudia Stratmann
- Kirsten Hüning
- Birgit Jaspers
- Michaela Hesse
- Isabel Franke
- Melanie Joshi
- Department of Palliative Medicine, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany
- Simone Matte
- Lena Dreher
- Gina Fürtjes
- Sophia Kochs
- Moritz Lenschow
- Patrick Melich
- Catharina Schröter
- Bianca-Ioana Blaß
- Debora Cipriani
- Dieter Henrik Heiland
- Pamela Heiland
- Nadja Jarc
- Nicole Koch
- Marcia Regina Machein
- Nicolas Neidert
- Mateo Farina Nunez
- Jolanda Daniuk
- Bianca Lauble
- Tina Meer
- Saskia Opitz
- Birgit Haberland
- Eva Lehmann
- Karla Steinberger
- Sabine Streitwieser
- Christoph Barth
- Stefanie Lietke
- Christiane Zimmerer
- DOI
- https://doi.org/10.1136/bmjopen-2019-034378
- Journal volume & issue
-
Vol. 10,
no. 1
Abstract
Introduction Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group.Methods and analysis The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)).The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival.Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences.Trial registration number German Register for Clinical Studies (DRKS) (DRKS00016066); Pre-results.
