Conducting a randomized controlled clinical trial on palliative care in patients with glioblastoma – what are the challenges?

PURPOSE: Patients with glioblastoma represent a highly vulnerable cohort as they often experience rapid health deterioration with severe symptom burden including neurological, (neuro)psychological, and psychiatric symptoms. The aim of this sub-analysis of the "Early Palliative Care for Patients with Glioblastoma" (EPCOG) trial was to investigate the specific challenges of conducting a multicenter, randomized, controlled, clinical trial in glioblastoma patients testing a specialized palliative care (PC) intervention. METHODS: We analyzed screening protocols and protocol deviations with respect to number and reasons for non-participation, skipped/delayed visits and attrition using descriptive statistics and content analysis of free-text comments. RESULTS: In total, 41.5% of 556 screened patients were enrolled. Main reasons for non-participation were lack of interest (25.7%) and low functional status (11.5%). Attrition due to death (57.6%) was higher than due to illness (5.2%) or other reasons (21.2%). Main reasons for visit deviations were structural issues (in > 50% of neurosurgical visits), health status, and patient request. Protocol deviations showed that specialized PC intervention visits were least frequently skipped (4.5%) compared to study-specific outcome assessment (10.1%) and neurosurgical (43.3%) visits. Further, only 11.0% of the specialized PC intervention visits were delayed compared to 22.3% of the outcome assessment and 56.4% of the neurosurgical visits. CONCLUSION: In this clinical trial involving glioblastoma patients, a high level of motivation among the study participants could be reached, as reflected by low protocol deviations during the specialized PC intervention and study-specific outcome assessment visits. Reasons for this might be a close guidance as well as a patient and caregiver-oriented communication, e.g., by a personal contact of the PC team in the intervention group, personal outcome assessment visits at patients' whereabouts, or the inclusion of a study nurse at each site. Considering the high vulnerability of glioblastoma patients is crucial when designing and conducting clinical trials.

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Publication Details

Journal
Supportive Care in Cancer
Published
2026-04-27
DOI
https://doi.org/10.1007/s00520-026-10564-7
Primary Topic
Glioma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00

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article

Conducting a randomized controlled clinical trial on palliative care in patients with glioblastoma – what are the challenges?

Sophia Kochs, Niklas Schäfer, Manuela Schallenburger, Petra Winter et al.
Supportive Care in Cancer
Glioma Diagnosis and Treatment
article

Conducting a randomized controlled clinical trial on palliative care in patients with glioblastoma – what are the challenges?

Sophia Kochs, Niklas Schäfer, Manuela Schallenburger, Petra Winter, Debora Cipriani, D. Delev, Christiane Landwehr, Franziska Schwartzkopff, Christina Schaub, Caterina Quente, Louisa von Baumgarten, Gina Fürtjes, Stefanie Stock, Daniele Civello, Daniel Rueß, Nicolas Neidert, Melanie Joshi, Stefanie Junger, Catharina Schröter, M Kamp, B Haberland, Stefanie Hamacher, Heidrun Golla, Mateo Tomas Fariña Núñez, D Müller, Christopher Boehlke, Yashar Naseri, Niklas von Spreckelsen, Nadja Jarc, Iris Appelmann, N. Koch, Gerhild Becker, Birgit Jaspers, Stefanie Quach, Sonja Hiddemann, Michaela Hesse, C. Stratmann, J. Daniuk, Myriam Peters, Patrick Melich, Irini Papachristou, Anna Vongerichten, Kirsten Hüning, Norbert Krumm, Lena Dreher, Charlotte Nettekoven, Isabel Franke, Anna-Katharina Meißner, Anne Müller, Melanie Adler, T Brumbarova, Petra Heiden, Bianca Blass, Pamela Heiland, Katarina Drömer, Hilde Cavelius, Marita Kumschlies, Manuela Langheimer, Christina Thamm, Mirco Muscheid, Derya Tezel, Nicole Dietrichs, Lena Koschnitzke, Natalie Meyer-Sevens, Bianca Lauble, Anja Wiegleb-Brunet, Martin Hellmich, Berit Zimmer, Dieter Henrik Heiland, Wiebke Müller, Simone Matte, Hans Clusmann, Erdem Güresir, Tina Meer, Roman Rolke, Jacqueline Schwartz, Ulrich Herrlinger, Stefan Grau, EPCOG Study Group, Saskia Opitz, Annika Brüggen, Maximilian I. Ruge, Roland Goldbrunner, Oliver Schnell, Christoph Barth, Marie Schulz, Jörg-Christian Tonn, Marion Rapp, Michael Sabel, Junko C. Hübers, Alina Glebova, Lukas Radbruch, Martin Neukirchen, Imke Bronger, Marcia Machein, Niklas Thon, Claudia Bausewein, Raymond Voltz, Hartmut Vatter, Chuh-Hyoun Na
article en

Abstract

PURPOSE: Patients with glioblastoma represent a highly vulnerable cohort as they often experience rapid health deterioration with severe symptom burden including neurological, (neuro)psychological, and psychiatric symptoms. The aim of this sub-analysis of the "Early Palliative Care for Patients with Glioblastoma" (EPCOG) trial was to investigate the specific challenges of conducting a multicenter, randomized, controlled, clinical trial in glioblastoma patients testing a specialized palliative care (PC) intervention. METHODS: We analyzed screening protocols and protocol deviations with respect to number and reasons for non-participation, skipped/delayed visits and attrition using descriptive statistics and content analysis of free-text comments. RESULTS: In total, 41.5% of 556 screened patients were enrolled. Main reasons for non-participation were lack of interest (25.7%) and low functional status (11.5%). Attrition due to death (57.6%) was higher than due to illness (5.2%) or other reasons (21.2%). Main reasons for visit deviations were structural issues (in > 50% of neurosurgical visits), health status, and patient request. Protocol deviations showed that specialized PC intervention visits were least frequently skipped (4.5%) compared to study-specific outcome assessment (10.1%) and neurosurgical (43.3%) visits. Further, only 11.0% of the specialized PC intervention visits were delayed compared to 22.3% of the outcome assessment and 56.4% of the neurosurgical visits. CONCLUSION: In this clinical trial involving glioblastoma patients, a high level of motivation among the study participants could be reached, as reflected by low protocol deviations during the specialized PC intervention and study-specific outcome assessment visits. Reasons for this might be a close guidance as well as a patient and caregiver-oriented communication, e.g., by a personal contact of the PC team in the intervention group, personal outcome assessment visits at patients' whereabouts, or the inclusion of a study nurse at each site. Considering the high vulnerability of glioblastoma patients is crucial when designing and conducting clinical trials.

Supportive Care in CancerVol. 34(5)
Northwestern University (US), University of Freiburg (DE), University of Cologne (DE), Friedrich-Alexander-Universität Erlangen-Nürnberg (DE), University Hospital Bonn (DE), University Medical Center Freiburg (DE), LMU Klinikum (DE), Düsseldorf University Hospital (DE), Integrated Oncology (United States) (US), St. Marien-Hospital Bonn (DE), Universitätsmedizin Göttingen (DE), LVR-Klinik Bonn (DE), Protestant University of Applied Sciences Freiburg (DE), University Hospital Cologne (DE), Heinrich Heine University Düsseldorf (DE), University of Göttingen (DE), Ludwig-Maximilians-Universität München (DE), RWTH Aachen University (DE)
Bundesministerium für Bildung und Forschung, Universitätsklinikum Köln
Openalex Percentile: Top 15%
Glioma Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
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