Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life
Affiliation:
1. Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy;2. Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy;3. Pain Therapy and Palliative Care Unit, Veneto Institute of Oncology IOV – IRCCS, Padua, Italy;4. Medical Oncology Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy;5. Medical Oncology Unit, San Paolo Hospital, Milan, Italy;6. Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;7. Palliative Care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy;8. Medical Oncology Unit, Presidio Humanitas Gradenigo, Turin, Italy;9. Medical Oncology Unit, Oncology Department, S. Maria Annunziata Hospital, Florence, Italy;10. Palliative Care Unit, Oncology Department, L. Sacco Hospital, Milan, Italy;11. Oncology Unit, Ospedale degli Infermi, Ponderano, BI, Italy;12. Palliative Care, Department of Geriatric, Orthogeriatric and Rehabilitation Frailty Area, E.O. Galliera Hospitals, Genoa, Italy;13. Oncology Unit, Sant’Anna Hospital, Como, Italy;14. Palliative Care Unit, Arcispedale S. Maria Nuova – IRCCS, Reggio Emilia, Italy;15. Oncology Unit, SS Trinità Hospital Sora, ASL Frosinone, Italy;p. Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology IOV – IRCCS, Padua, Italy;q. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy;1. Department of Medical Oncology, Istituto Scientifico Romagnolo per Lo Studio e Cura Dei Tumori (IRST) IRCCS, Meldola, Italy;2. Department of Medical Oncology, University of Cagliari, Italy;3. Biosciences Laboratory, Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST) IRCCS, Meldola, Italy;4. Department of Internal Medicine, Degli Infermi Hospital, Faenza, Italy;5. Department of Medical Oncology, National Cancer Institute Giovanni Paolo II, Bari, Italy;6. Department of Medical and Surgical Sciences, Sant''Orsola-Malpighi Hospital, University of Bologna, Italy;7. Department of Biomedical Sciences and Human Oncology, Clinica Medica A. Murri, University of Bari Medical School, Italy;8. Internal Medicine and Hepatology Unit, Università Campus Bio-Medico, Rome, Italy;9. Department of Pathology, Università Campus Bio-Medico, Rome, Italy;10. Immunotherapy Unit, Istituto Scientifico Romagnolo per Lo Studio e Cura Dei Tumori (IRST) IRCCS, Meldola, Italy;11. Department of General Surgery, Morgagni-Pierantoni Hospital, Forlì, Italy;12. Department of Medical Oncology, Infermi Hospital, Rimini, Italy;13. Department of Oncology, University and General Hospital, Udine, Italy;14. Medical Oncology Unit, Università Campus Bio-Medico, Rome, Italy;15. Modena Cancer Center, Policlinico di Modena, Università di Modena e Reggio Emilia, Italy;1. European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway;2. The Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;3. University of Edinburgh, Edinburgh, Scotland, United Kingdom;1. European Palliative Care Research Centre, Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, N-0424 Oslo, Norway;1. Department of Public Health Sciences, Leonard M. Miller School of Medicine, University of Miami, Coral Gables, FL, USA;2. Institute for Advanced Study of the Americas, University of Miami, Coral Gables, FL, USA;3. Sylvester Comprehensive Cancer Center, University of Miami, Coral Gables, FL, USA;4. School of Business Administration, University of Miami, Coral Gables, FL, USA;5. Tómatelo a Pecho, A.C., Mexico City, Mexico;6. Fundación Mexicana para la Salud, A.C., Mexico City, Mexico;7. Harvard Medical School, Boston, MA, USA;8. Massachusetts General Hospital, Boston, MA, USA;9. World Health Organization, Geneva, Switzerland;10. International Association for Hospice and Palliative Care, Houston, TX, USA;11. Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA;12. Department of Health Policy and Management, Harvard T.H. Chan School of Public Health, Boston, MA, USA;13. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA;14. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA;15. National Institute of Public Health, Morelos, Mexico;p. Pan American Health Organization, Regional Office of WHO, Washington, DC, USA;q. Worldwide Hospice Palliative Care Alliance, London, UK;r. Nuffield Department of Population Health, University of Oxford, Oxford, UK;s. Health and Human Rights Division, Human Rights Watch, Maplewood, NJ, USA;t. Department of Palliative Medicine, University Hospital Bonn, Germany;u. The Malteser Hospital, Bonn, Germany;v. Costa Rican Social Security Fund, San José, Costa Rica;w. Weill Cornell Medical College, New York City, NY, USA;x. University of California, San Francisco, CA, USA;y. Trivandrum Institute of Palliative Sciences, WHO Collaborating Centre for Training and Policy on Access to Pain Relief, Pallium India, Kerala, India;1. Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA;2. Palliative Care Team, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan;3. Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton, AB, Canada;4. Palliative Care, Pain Therapy and Rehabilitation, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy;5. Oncological Palliative Medicine, Hematology-Oncology, Cantonal Hospital, St Gallen, Switzerland;6. Department of Palliative Care, Helsinki University Central Hospital, Cancer Center, Helsinki, Finland;7. Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel;8. Pain and Palliative Care Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA;9. European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway;10. Department of Oncology, Oslo University Hospital and University of Oslo, Oslo, Norway;1. The “Qualy” Observatory/WHO Collaborating Center for Palliative Care Public Health Programs, Catalan Institute of Oncology, Barcelona, Spain;2. Chair in Palliative Care, University of Vic, Barcelona, Spain;3. Primary Palliative Care Research Group, The Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, Scotland, UK;4. End of Life Care, University of Birmingham, Birmingham, UK;5. Chronic Care Program, Catalan Department of Health, Government of Catalonia, Barcelona, Spain;6. Education and Health Practices Laboratory, University Paris 13, Sorbonne Paris Cité, Bobigny, France;7. Health Simulation CenterSimUSanté®, Amiens University Hospital, Amiens, France;8. Research Group Palliative Care, Department of Primary and Interdisciplinary Care, Faculty of Medicine and Health Care, University of Antwerp, Antwerp, Belgium;9. Department of Anaesthesiology, Pain, Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands;10. Scientific Institute for Quality of Healthcare (IQ Healthcare), Radboud University Medical Centre, Nijmegen, The Netherlands;11. Palliative Care Unit, IRCCS Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy
Abstract:
AimEarly palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs.Patients and methodsData for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned to receive standard cancer care plus on-demand EPC (standard arm) or standard cancer care plus systematic EPC (interventional arm). After 20 months' follow-up, 149 (80%) had died. Outcome measures were frequency, type and timing of chemotherapy administration, use of resources, place of death and overall survival.ResultsSome indices of end-of-life (EoL) aggressiveness had a favourable impact from systematic EPC. Interventional arm patients showed higher use of hospice services: a significantly longer median and mean period of hospice care (P = 0.025 for both indexes) and a significantly higher median and mean number of hospice admissions (both P < 0.010). In the experimental arm, chemotherapy was performed in the last 30 days of life in a significantly inferior rate with respect to control arm: 18.7% versus 27.8% (adjusted P = 0.036). Other non-significant differences were seen in favour of experimental arm.ConclusionsSystematic EPC showed a significant impact on some indicators of EoL treatment aggressiveness. These data, reinforced by multiple non-significant differences in most of the other items, suggest that quality of care is improved by this approach.This study is registered on ClinicalTrials.gov (NCT01996540).
