• Emanuela Scarpi, Monia Dall'Agata, Vittorina Zagonel, Teresa Gamucci, Raffaella Bertè, Elisabetta Sansoni, Elena Amaducci, Chiara Maria Broglia, Sara Alquati, Ferdinando Garetto, Stefania Schiavon, Silvia Quadrini, Elena Orlandi, Andrea Casadei Gardini, Silvia Ruscelli, Daris Ferrari, Maria Simona Pino, Roberto Bortolussi, Federica Negri, Silvia Stragliotto, Filomena Narducci, Martina Valgiusti, Alberto Farolfi, Oriana Nanni, Romina Rossi, Marco Maltoni, and Early Palliative Care Italian Study Group (EPCISG).
• Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, FC, Italy. emanuela.scarpi@irst.emr.it.
• Support Care Cancer. 2019 Jul 1; 27 (7): 2425-2434.

PurposeEarly palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.MethodsIn this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.ResultsThe mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.ConclusionsOur results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.Clinical Trial RegistrationClinicalTrials.gov (NCT01996540).

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