Early Palliative Care for Patients with Glioblastoma: A randomized phase lll clinical trial (EPCOG)

Abstract

Background: Positive effects of early integration of palliative care (EIPC) have been shown for systemic solid malignant tumors. We tested the hypothesis that EIPC improves quality of life (QoL), palliative care (PC) problems and mood in glioblastoma patients and reduces caregiver burden.

Methods: This randomized, rater-blinded, controlled trial conducted in six German university medical centers included glioblastoma patients within four weeks after diagnosis (first/recurrent) and their caregivers. Patients received standard care (control) or standard care and EIPC (intervention) for 12 months. Primary outcome was change in QoL after six months measured by the trial outcome index of the FACT-Br. Data were assessed 3-monthly for up to 24 months.

Results: Between 05/2019 and 04/2021 patients were enrolled and randomized to the intervention (n = 109) or control group (n = 108). QoL at month six was in favor of the intervention, however not statistically significant (mean difference 4·1 with 95%-CI -4·4 to 12·6, p = 0·34; intervention: n = 98 (m = 54/f=44); control: n = 89 (m = 50/f=39)). In an analysis adjusted for time of death, performed because of a significant survival difference (control superior to intervention, p = 0·018), QoL was better in the intervention group (p = 0·041). Secondary outcomes showed that patients significantly benefited from EIPC regarding PC problems and mood especially after intervention ended, while caregivers did not seem to benefit.

Conclusion: Provided that the survival difference is included in the analysis, EIPC improves QoL in glioblastoma patients. This, in addition to improved mood and PC problems, demonstrates that EIPC sustainably improves 'how to live' but not 'length of life'.

Keywords: Glioblastoma; caregiver; early integration of palliative care; quality of life; sustainability.