TY - JOUR
T1 - Systematic vs. on-demand early palliative care in gastric cancer patients
T2 - a randomized clinical trial assessing patient and healthcare service outcomes
AU - Early Palliative Care Italian Study Group (EPCISG)
AU - Scarpi, Emanuela
AU - Dall'Agata, Monia
AU - Zagonel, Vittorina
AU - Gamucci, Teresa
AU - Bertè, Raffaella
AU - Sansoni, Elisabetta
AU - Amaducci, Elena
AU - Broglia, Chiara Maria
AU - Alquati, Sara
AU - Garetto, Ferdinando
AU - Schiavon, Stefania
AU - Quadrini, Silvia
AU - Orlandi, Elena
AU - Casadei Gardini, Andrea
AU - Ruscelli, Silvia
AU - Ferrari, Daris
AU - Pino, Maria Simona
AU - Bortolussi, Roberto
AU - Negri, Federica
AU - Stragliotto, Silvia
AU - Narducci, Filomena
AU - Valgiusti, Martina
AU - Farolfi, Alberto
AU - Nanni, Oriana
AU - Rossi, Romina
AU - Maltoni, Marco
PY - 2018/10/24
Y1 - 2018/10/24
N2 - 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).
AB - 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).
U2 - 10.1007/s00520-018-4517-2
DO - 10.1007/s00520-018-4517-2
M3 - Article
C2 - 30357555
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
SN - 0941-4355
ER -