Effect of early palliative care for patients with glioblastoma (EPCOG): a randomised phase III clinical trial protocol. Issue 1 (7th January 2020)

• Record Type: Journal Article
• Authors: Golla, Heidrun; Nettekoven, Charlotte; Bausewein, Claudia; Tonn, Jörg-Christian; Thon, Niklas; Feddersen, Berend; Schnell, Oliver; Böhlke, Christopher; Becker, Gerhild; Rolke, Roman; Clusmann, Hans; Herrlinger, Ulrich; Radbruch, Lukas; Vatter, Hartmut; Güresir, Erdem; Stock, Stephanie; Müller, Dirk; Civello, Daniele; Papachristou, Irini; Hellmich, Martin; Hamacher, Stefanie; Voltz, Raymond; Goldbrunner, Roland
• Other Names: author non-byline.; Bronger Imke author non-byline.; Dederichs Kerstin author non-byline.; Cavelius Hildegard author non-byline.; Hiddemann Sonja author non-byline.; Krumm Norbert author non-byline.; Thamm Christina author non-byline.; Delev Daniel author non-byline.; Kumschlies Marita author non-byline.; Langheimer Manuela author non-byline.; Na Chuh-Hyoun author non-byline.; Landwehr Christiane author non-byline.; Schäfer Niklas author non-byline.; Schaub Christina author non-byline.; Stratmann Claudia author non-byline.; Hüning Kirsten author non-byline.; Jaspers Birgit author non-byline.; Hesse Michaela author non-byline.; Franke Isabel author non-byline.; Joshi Melanie author non-byline.; Matte Simone author non-byline.; Dreher Lena author non-byline.; Fürtjes Gina author non-byline.; Kochs Sophia author non-byline.; Lenschow Moritz author non-byline.; Melich Patrick author non-byline.; Schröter Catharina author non-byline.; Blaß Bianca-Ioana author non-byline.; Cipriani Debora author non-byline.; Heiland Dieter Henrik author non-byline.; Heiland Pamela author non-byline.; Jarc Nadja author non-byline.; Koch Nicole author non-byline.; Machein Marcia Regina author non-byline.; Neidert Nicolas author non-byline.; Nunez Mateo Farina author non-byline.; Daniuk Jolanda author non-byline.; Lauble Bianca author non-byline.; Meer Tina author non-byline.; Opitz Saskia author non-byline.; Haberland Birgit author non-byline.; Lehmann Eva author non-byline.; Steinberger Karla author non-byline.; Streitwieser Sabine author non-byline.; Barth Christoph author non-byline.; Lietke Stefanie author non-byline.; Zimmerer Christiane author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 1(2020)
• Publication Date: 2020-01-07
• Subjects: early integration of palliative care -- RCT -- quality of life -- caregiver burden -- glioblastoma -- palliative care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-034378
• Languages: English
• ISSNs: 2044-6055

Abstract

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.