Impact of early palliative care according to baseline symptom severity: Secondary analysis of a cluster-randomized controlled trial in patients with advanced cancer

Background: Early palliative care (EPC) improves the quality of life but may not be feasible for all patients with advanced cancer. Symptom screening has been suggested to triage patients for EPC, but scant evidence exists for this practice. Methods: We conducted a subgroup analysis of a cluster-randomized controlled trial of EPC vs. standard oncology care according to patients' baseline symptom scores (high [>23] vs. low [≤23] Edmonton Symptom Assessment System Distress Score [ESAS SDS]). A linear mixed-effects model was used to account for correlation within clusters, adjusting for the baseline outcome score and all covariates in the original trial. Results: Among the 461 participants, baseline symptom scores were high in 229 patients (127 intervention, 102 control) and low in 232 (101 intervention and 131 control). Among those with high baseline symptoms, there was improved quality of life in the EPC arm compared to controls at 4 months (adjusted difference in primary outcome of FACIT-Sp change score [95% CI], 8.7 [2.8 to 14.5], p = 0.01; adjusted difference in QUAL-E, 4.2 [0.9–7.5], p = 0.02); there was also improved satisfaction with care (6.9 [3.8–9.9], p = 0.001) and clinician-patient interactions (−1.7 [−3.4 to −0.1], p = 0.04), but no significant difference in ESAS SDS (−5.6 [−12.7 to 1.4], p = 0.11). In the low baseline symptom group, there were no significant differences between arms for any outcomes. Conclusion: EPC improved quality of life, satisfaction with care, and clinician-patient interactions only in those with high baseline symptoms. Symptom severity may be an appropriate criterion to trigger early referrals to palliative care.