Systematic vs. on-demand early palliative care in gastric cancer patients : a randomized clinical trial assessing patient and healthcare service outcomes

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SCARPI, Emanuela | DALL'AGATA, Monia | ZAGONEL, Vittorina | GAMUCCI, Teresa | BERTE, Raffaella | SANSONI, Elisabetta | AMADUCCI, Elena | BROGLIA, Chiara Maria | ALQUATI, Sara | GARETTO, Ferdinando | SCHIAVON, Stefania | QUADRINI, Silvia | ORLANDI, Elena | CASADEI GARDINI, Andrea | RUSCELLI, Silvia | FERRARI, Daris | PINO, Maria Simona | BORTOLUSSI, Roberto | NEGRI, Federica | STRAGLIOTTO, Silvia | NARDUCCI, Filomena | VALGIUSTI, Martina | FAROLFI, Alberto | NANNI, Oriana | ROSSI, Romina | MALTONI, Marco | EARLY PALLIATIVE CARE ITALIAN STUDY GROUP (EPCISG)

PURPOSE: Early 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. METHODS: In 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. RESULTS: The 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. CONCLUSIONS: Our 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 REGISTRATION: ClinicalTrials.gov (NCT01996540).

http://dx.doi.org/10.1007/s00520-018-4517-2

Voir la revue «Supportive care in cancer»

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