Marco Maltoni1, Emanuela Scarpi2, Monia Dall'Agata3, Vittorina Zagonel4, Raffaella Bertè5, Daris Ferrari6, Chiara Maria Broglia7, Roberto Bortolussi8, Leonardo Trentin9, Martina Valgiusti10, Sara Pini10, Alberto Farolfi10, Andrea Casadei Gardini10, Oriana Nanni3, Dino Amadori10. 1. Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)-IRCCS, Meldola, Italy. 2. Biostatistics and Clinical Trials Unit, IRST-IRCCS, Meldola, Italy. Electronic address: emanuela.scarpi@irst.emr.it. 3. Biostatistics and Clinical Trials Unit, IRST-IRCCS, Meldola, Italy. 4. Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy. 5. Palliative Care, Oncology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy. 6. Palliative Care Unit, Oncology Department, Azienda Ospedaliera San Paolo, Milano, Italy. 7. Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 8. Palliative Care and Pain Therapy Unit, Centro di Riferimento Oncologico di Aviano, IRCCS, Aviano, Italy. 9. Palliative Care and Pain Therapy Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy. 10. Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
Abstract
BACKGROUND: Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. METHODS: This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive 'standard cancer care plus on-demand EPC' (n = 100) or 'standard cancer care plus systematic EPC' (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy - Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. FINDINGS: The mean changes in TOI score and HCS score between T0 and T1 were -4.47 and -0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10-7.57) (p = 0.041), and -2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40-4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. INTERPRETATIONS: Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC.
RCT Entities:
BACKGROUND: Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. METHODS: This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive 'standard cancer care plus on-demand EPC' (n = 100) or 'standard cancer care plus systematic EPC' (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy - Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. FINDINGS: The mean changes in TOI score and HCS score between T0 and T1 were -4.47 and -0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10-7.57) (p = 0.041), and -2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40-4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. INTERPRETATIONS: Systematic EPC in advanced pancreatic cancerpatients significantly improved QoL with respect to on-demand EPC.
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Authors: 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 Journal: Support Care Cancer Date: 2018-10-24 Impact factor: 3.603