Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life.
Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs.



Data 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.



Some 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.



Systematic 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).
Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Marco
M
Maltoni
Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy. Electronic address: emanuela.scarpi@irst.emr.it.
Emanuela
E
Scarpi
Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Monia
M
Dall'Agata
Pain Therapy and Palliative Care Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Stefania
S
Schiavon
Medical Oncology Unit, Oncology-Hematology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy.
Claudia
C
Biasini
Medical Oncology Unit, San Paolo Hospital, Milan, Italy.
Carla
C
Codecà
Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Chiara Maria
CM
Broglia
Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Elisabetta
E
Sansoni
Palliative Care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy.
Roberto
R
Bortolussi
Medical Oncology Unit, Presidio Humanitas Gradenigo, Turin, Italy.
Ferdinando
F
Garetto
Medical Oncology Unit, Oncology Department, S. Maria Annunziata Hospital, Florence, Italy.
Luisa
L
Fioretto
Palliative Care Unit, Oncology Department, L. Sacco Hospital, Milan, Italy.
Maria Teresa
MT
Cattaneo
Oncology Unit, Ospedale degli Infermi, Ponderano, BI, Italy.
Alice
A
Giacobino
Palliative Care, Department of Geriatric, Orthogeriatric and Rehabilitation Frailty Area, E.O. Galliera Hospitals, Genoa, Italy.
Massimo
M
Luzzani
Oncology Unit, Sant'Anna Hospital, Como, Italy.
Giovanna
G
Luchena
Palliative Care Unit, Arcispedale S. Maria Nuova - IRCCS, Reggio Emilia, Italy.
Sara
S
Alquati
Oncology Unit, SS Trinità Hospital Sora, ASL Frosinone, Italy.
Silvia
S
Quadrini
Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Vittorina
V
Zagonel
Medical Oncology Unit, Oncology-Hematology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy.
Luigi
L
Cavanna
Medical Oncology Unit, San Paolo Hospital, Milan, Italy.
Daris
D
Ferrari
Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Paolo
P
Pedrazzoli
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Giovanni Luca
GL
Frassineti
Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Antonella
A
Galiano
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Andrea
A
Casadei Gardini
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Manlio
M
Monti
Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy.
Oriana
O
Nanni
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003695:Delivery of Health Care / Q000379:methods; D005260:Female; D017051:Hospice Care / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010166:Palliative Care / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000628:therapy*; D011787:Quality of Health Care; D011788:Quality of Life; D013727:Terminal Care / Q000592:standards*; D013997:Time Factors
D000970:Antineoplastic Agents
Care aggressiveness near the end of life; Early palliative care; Use of health care services