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Specialized palliative care intervention enrollment patterns in a glioblastoma randomized controlled trial sub-analysisGlioblastoma trial reveals why patients skip or delay visits

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Key Takeaway
Note high attrition due to death (57.6%) and low functional status (11.5%) in vulnerable glioblastoma patients.

This study was a sub-analysis of the Early Palliative Care for Patients with Glioblastoma (EPCOG) randomized controlled clinical trial. The population consisted of patients with glioblastoma, with 556 screened patients and 41.5% enrolled in the trial. The setting was multicenter. The intervention was a specialized palliative care (PC) intervention. The comparator was not reported.

Regarding non-participation reasons among screened patients, lack of interest was reported in 25.7% and low functional status in 11.5%. For attrition reasons, death accounted for 57.6%, illness for 5.2%, and other reasons for 21.2%. Frequency of skipped visits showed specialized PC intervention visits at 4.5%, study-specific outcome assessment at 10.1%, and neurosurgical visits at 43.3%. Delayed visits occurred for specialized PC intervention visits in 11.0%, outcome assessment in 22.3%, and neurosurgical visits in 56.4%.

Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported. The study had a key limitation regarding the high vulnerability of glioblastoma patients. Practice relevance suggests that considering the high vulnerability of glioblastoma patients is crucial when designing and conducting clinical trials.

A new analysis of a clinical trial for glioblastoma, a fast-growing brain cancer, reveals why many patients did not fully participate. Researchers looked at data from the EPCOG trial, which tested early palliative care for people with this aggressive disease.

Of 556 patients screened, only about 41% enrolled. The most common reasons for not joining were lack of interest (25.7%) and low functional status (11.5%). Among those who did enroll, many dropped out, mainly due to death (57.6%) or illness (5.2%).

Even among patients who stayed in the trial, visits were often skipped or delayed. For example, neurosurgical visits were skipped 43.3% of the time and delayed 56.4% of the time. Specialized palliative care visits were skipped less often (4.5%) but still delayed 11% of the time.

The study highlights the challenges of conducting research in very sick patients. The authors note that the high vulnerability of glioblastoma patients must be considered when designing future trials. This analysis does not report on the effectiveness of palliative care, only on participation patterns.

What this means for you:
Glioblastoma patients often skip or delay trial visits due to illness or death, affecting study results.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original 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.
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