Emanuela Scarpi1, Monia Dall'Agata2, Vittorina Zagonel3, Teresa Gamucci4, Raffaella Bertè5, Elisabetta Sansoni6, Elena Amaducci7, Chiara Maria Broglia8, Sara Alquati9, Ferdinando Garetto10, Stefania Schiavon3, Silvia Quadrini4, Elena Orlandi11, Andrea Casadei Gardini12, Silvia Ruscelli12, Daris Ferrari13, Maria Simona Pino14, Roberto Bortolussi15, Federica Negri16, Silvia Stragliotto3, Filomena Narducci4, Martina Valgiusti12, Alberto Farolfi12, Oriana Nanni2, Romina Rossi6, Marco Maltoni6. 1. 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. 2. 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. 3. Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy. 4. Oncology Unit, SS Trinità Hospital, Sora, ASL Frosinone, Italy. 5. Palliative Care, Oncology Department, Guglielmo da Saliceto Hospital, AUSL, Piacenza, Italy. 6. Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei, Tumori (IRST) IRCCS, Meldola, Italy. 7. Palliative Care and Hospice Unit, AUSL Romagna, Cesena, Italy. 8. Oncology Unit, Fondazione IRCCS, Policlinico San Matteo, Pavia, Italy. 9. Palliative Care Unit, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy. 10. Medical Oncology Unit, Presidio Humanitas Gradenigo, Torino, Italy. 11. Medical Oncology Unit, Oncology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy. 12. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 13. Oncology Unit, San Paolo Hospital, Milan, Italy. 14. Medical Oncology Unit, Oncology Department, Azienda USL Toscana Centro, S. Maria Annunziata Hospital, Florence, Italy. 15. Palliative care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy. 16. Medical Oncology Unit, Azienda Socio Sanitaria Territoriale, Cremona, Italy.
Abstract
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).
RCT Entities:
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 cancerpatients 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).
Entities:
Keywords:
Aggressiveness in end of life; Early palliative care; Quality of care; Quality of life
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