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Purpose <p>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.</p> Methods <p>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.</p> Results <p>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 &gt; 50% of neurosurgical visits), health status, and patient request. Protocol deviations showed that&#xa0;specialized PC&#xa0;intervention&#xa0;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.</p> Conclusion <p>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.</p>

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

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  • 发表日期：

    2026年4月27日

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

摘要

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.