Early palliative care and quality of life of advanced cancer patients—a multicenter randomized clinical trial

Patients with advanced cancer and their families frequently experience a high burden of suffering, which is not limited to the last days of life but occurs throughout the illness. The complex physical, psychological, social, and spiritual consequences of the disease typically affecting patients are often neglected by the common disease-centered approach (1,2). Palliative care (PC) is focused on patients and their families, with the aim to relieve suffering and achieve the best possible quality of life (QoL) (2). PC in oncology has traditionally been considered synonymous with end-of-life (EoL) care, to be administered when no cancer treatment is indicated (3,4). Based on evidence from randomized clinical trials (5-10) and meta-analyses (11,12), the oncology and PC communities (13-15) as well as the World Health Organization (WHO) (16) recommend early palliative care (EPC) soon after the diagnosis of advanced cancer. However, literature reviews emphasize that additional research is necessary to further understand the role of EPC in different cancer types and to characterize the optimal delivery and settings of the palliative interventions (11,17,18). At the time our study was designed, only two randomized trials assessing EPC interventions in patients with advanced cancer had been published (5,6). Bakitas et al. reported significantly higher QoL and mood for a psychoeducational intervention with nurse practitioners vs. SOC in patients newly diagnosed with different types of cancers (5). Temel et al. randomized patients with newly diagnosed metastatic palliative care non-small-cell lung cancer (NSCLC) to receive either EPC plus SOC or SOC alone, and observed that patients assigned to the intervention had significantly higher QoL scores, fewer depressive symptoms, less aggressive EoL care and longer survival (6). We thus report the results of a multicenter, randomized controlled trial of EPC versus SOC on the QoL of patients with different types of advanced cancers (NSCLC, pancreatic, gastric and biliary tract) treated at Italian cancer centers