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

Clinical Snapshot

Key Findings

• P Value: Not reported - descriptive analysis

• Effect Size: Not applicable - feasibility study

• Primary Outcome: Trial feasibility with 41.5% enrollment rate from 556 screened patients

• Nnt Or Sensitivity: Specialized PC visits had lowest deviation rate (4.5% skipped, 11.0% delayed)

• Confidence Interval: Not reported

Clinical Application

Demonstrates that specialized palliative care trials are feasible in glioblastoma patients with appropriate support structures Relevant for Australian neuro-oncology services; aligns with Cancer Australia guidelines for integrated palliative care and could inform PBS-funded palliative care programs Patients with glioblastoma requiring palliative care intervention in tertiary neurosurgical centers

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.

References

1. 1.Joshi, M., Nettekoven, C., Kochs, S., Appelmann, I., Bausewein, C., Becker, G., Boehlke, C., Brumbarova, T., Civello, D., Clusmann, H., Goldbrunner, R., Haberland, B., Heiland, D. H., Hellmich, M., Herrlinger, U., Jaspers, B., Müller, D., Müller, W., Na, C.-H., Neukirchen, M., Radbruch, L., Rapp, M., Rolke, R., Ruge, M. I., Sabel, M., Schnell, O., Schwartz, J., Thon, N., Vatter, H., von Baumgarten, L., Voltz, R., & Golla, H. (2026). Conducting a randomized controlled clinical trial on palliative care in patients with glioblastoma - what are the challenges? *Supportive Care in Cancer*. https://doi.org/10.1111/jgs.15988