title: Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC.
authors.affiliation: Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)-IRCCS, Meldola, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Maltoni
authors.affiliation: Biostatistics and Clinical Trials Unit, IRST-IRCCS, Meldola, Italy. Electronic address: emanuela.scarpi@irst.emr.it.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Scarpi
authors.affiliation: Biostatistics and Clinical Trials Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Monia
authors.initials: M
authors.lastname: Dall'Agata
authors.affiliation: Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.
authors.forename: Vittorina
authors.initials: V
authors.lastname: Zagonel
authors.affiliation: Palliative Care, Oncology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bertè
authors.affiliation: Palliative Care Unit, Oncology Department, Azienda Ospedaliera San Paolo, Milano, Italy.
authors.forename: Daris
authors.initials: D
authors.lastname: Ferrari
authors.affiliation: Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Chiara Maria
authors.initials: CM
authors.lastname: Broglia
authors.affiliation: Palliative Care and Pain Therapy Unit, Centro di Riferimento Oncologico di Aviano, IRCCS, Aviano, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bortolussi
authors.affiliation: Palliative Care and Pain Therapy Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Trentin
authors.affiliation: Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Valgiusti
authors.affiliation: Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Pini
authors.affiliation: Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Farolfi
authors.affiliation: Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Casadei Gardini
authors.affiliation: Biostatistics and Clinical Trials Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Oriana
authors.initials: O
authors.lastname: Nanni
authors.affiliation: Medical Oncology Unit, IRST-IRCCS, Meldola, Italy.
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000517:prevention & control; D003863:Depression / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000523:psychology / Q000628:therapy*; D000070659:Patient Comfort; D011446:Prospective Studies; D011787:Quality of Health Care; D011788:Quality of Life
keywords: Early palliative care; Quality of care; Quality of life