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The aim of this sub-analysis of the \u201cEarly Palliative Care for Patients with Glioblastoma\u201d (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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats: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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats: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\u2009&gt;\u200950% of neurosurgical visits), health status, and patient request. Protocol deviations showed that\u00a0specialized PC\u00a0intervention\u00a0visits 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats: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\u2019 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00520-026-10564-7","type":"journal-article","created":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T09:45:02Z","timestamp":1777283102000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Conducting a randomized controlled clinical trial on palliative care in patients with glioblastoma \u2013 what are the 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Approval was granted by the Ethics Committee of the University Hospitals of Cologne (#19-1024_7), Aachen (#EK 147\/19), Bonn (#AZ 150\/9), Freiburg (#194\/19), Munich (LMU) (#19-279), and D\u00fcsseldorf (#2020-862).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"HG is co-speaker of the German Society of Neurology (DGN) commission for Neuropalliative Care. UH received speakers and\/or advisory board honoraria from Servier, Medac and Bayer. LR is chair of the Board of Directors of the International Association for Hospice and Palliative Care (IAHPC). RR is co-speaker of the physicians\u2019 section of the German Association of Palliative Medicine. 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