Early Palliative Care in Real-World Clinical Practice: Effectiveness Regarding Quality of Life and Symptoms of Newly Diagnosed Advanced Cancer Outpatients in Comprehensive Cancer Centres - A Multicentre, Mixed-Methods, Sequential Control Group Study (EVI Project)

Background: The evidence for early palliative care (EPC) often lacks external validity. Real-world clinical practice approaches are therefore urgently needed. This study aims to assess the effectiveness of EPC regarding patients' quality of life (QoL) and symptoms (secondary outcomes). Methods: This is a prospective, multicentre, mixed-methods, cohort study with a sequential control group design (DRK6162). We included adult outpatients with incurable advanced cancer diagnosed within the preceding eight weeks. The control group (CG) received standard oncology care and was compared to standard oncology care plus uniprofessional, EPC by a PC physician or PC nurse. We used mixed models to analyse the Palliative Outcome Scale (POS) and European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 (EORTC QLQ-C30) at baseline, week 12, and week 24. Patients' and respective caregivers' subjective understanding of QoL was analysed with semi-structured interviews and content analysis. Findings: For the CG and intervention cohort (IG), we screened 1439 and 1716 patients, 338 and 254 entered the study, and 116 (34%) and 88 (35%) patients were available for Complete-Case analysis. Baseline characteristics were balanced between groups. For week 12, the POS score was 9·31 (95% confidence interval 8·25-10·37) in the CG and 9·74 (8·50-11·00) in the IG (difference: -0·44 (-2·45 to 1·58)). The QoL scale of the QLQ-C30 was 60·8 (95% confidence interval 56·9-64·8) in the CG and 55·1 (50·5-59·8) in the IG (difference: 5·7 (-1·8 to 13·2)). Subjective concepts of QoL were more differentiated in the IG (44 patients, 40 caregivers). Interpretation: QoL and symptoms were not different between groups. Qualitative data suggest a more elaborated concept of QoL in the IG. Future real-world studies are needed to find a balance between versus systemic as well as uniprofessional versus multiprofessional for an efficient and cost-effective EPC approach. Funding: Robert Bosch Stiftung: 11.5.1364.0055.0. Declaration of Interest: Siemens, W.: No competing interests to declare. Orellana-Rios, C.L.: No competing interests to declare. Schonsteiner, S. S.: No competing interests to declare. Schaekel, U.: No competing interests to declare. Kessler, J.: No competing interests to declare. Eschbach, C.: No competing interests to declare. Viehrig, M.: No competing interests to declare. Becker, G.: No competing interests to declare. Gaertner, J: No competing interests to declare. Ethical Approval: The Ethics Committee of the University of Freiburg (Germany) approved the study protocol on April 25, 2014 (vote: 193/14).