Systematic versus on-demand early palliative care

results from a multicentre, randomised clinical trial

Marco Cesare Maltoni, Emanuela Scarpi, Monia Dall'Agata, Vittorina Zagonel, Raffaella Bertè, Daris Ferrari, Chiara Maria Giovann Broglia, Roberto Bortolussi, Leonardo Trentin, Martina Valgiusti, Sara Pini, Alberto Farolfi, Andrea Casadei Gardini, Oriana Nanni, Dino Amadori, Giovanni Luca Paolo Frassineti, E. Sansoni, Angela Ragazzini, Silvia Ruscelli, Gino Crivellari & 34 others A. Galiano, Maria Grazia Rodriquenz, Claudia Biasini, Rosa Porzio, Cristina Pittureri, E. Amaducci, Marina Faedi, Carla Codecà, Francesca Crepaldi, Paolo Pedrazzoli, Alfina Bramanti, Angela Buonadonna, Ferdinando Garetto, A. Comandone, M. Giordano, Giovanna Luchena, Massimo Luzzani, Chiara Cifatte, M. S. Pino, Sonia Zoccali, M. T. Cattaneo, Davide Dalu, Pietro Sozzi, Roberta Gauna, Sara Alquati, Massimo Costantini, S. Quadrini, Filomena Narducci, Cataldo Mastromauro, Rodolfo Scognamiglio, D. Degiovanni, Federica Negri, Augusto Tommaso Caraceni, L. Montanari

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)61-68
Number of pages8
JournalEuropean Journal of Cancer
Volume65
DOIs
Publication statusPublished - Sep 1 2016

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Palliative Care
Randomized Controlled Trials
Liver Neoplasms
Quality of Life
Pancreatic Neoplasms
Confidence Intervals
Neoplasms
Survival
Quality of Health Care
Multicenter Studies
Outpatients
Costs and Cost Analysis
Therapeutics

Keywords

  • Early palliative care
  • Quality of care
  • Quality of life

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

Systematic versus on-demand early palliative care : results from a multicentre, randomised clinical trial. / Maltoni, Marco Cesare; Scarpi, Emanuela; Dall'Agata, Monia; Zagonel, Vittorina; Bertè, Raffaella; Ferrari, Daris; Broglia, Chiara Maria Giovann; Bortolussi, Roberto; Trentin, Leonardo; Valgiusti, Martina; Pini, Sara; Farolfi, Alberto; Casadei Gardini, Andrea; Nanni, Oriana; Amadori, Dino; Frassineti, Giovanni Luca Paolo; Sansoni, E.; Ragazzini, Angela; Ruscelli, Silvia; Crivellari, Gino; Galiano, A.; Rodriquenz, Maria Grazia; Biasini, Claudia; Porzio, Rosa; Pittureri, Cristina; Amaducci, E.; Faedi, Marina; Codecà, Carla; Crepaldi, Francesca; Pedrazzoli, Paolo; Bramanti, Alfina; Buonadonna, Angela; Garetto, Ferdinando; Comandone, A.; Giordano, M.; Luchena, Giovanna; Luzzani, Massimo; Cifatte, Chiara; Pino, M. S.; Zoccali, Sonia; Cattaneo, M. T.; Dalu, Davide; Sozzi, Pietro; Gauna, Roberta; Alquati, Sara; Costantini, Massimo; Quadrini, S.; Narducci, Filomena; Mastromauro, Cataldo; Scognamiglio, Rodolfo; Degiovanni, D.; Negri, Federica; Caraceni, Augusto Tommaso; Montanari, L.

In: European Journal of Cancer, Vol. 65, 01.09.2016, p. 61-68.

Research output: Contribution to journalArticle

Maltoni, MC, Scarpi, E, Dall'Agata, M, Zagonel, V, Bertè, R, Ferrari, D, Broglia, CMG, Bortolussi, R, Trentin, L, Valgiusti, M, Pini, S, Farolfi, A, Casadei Gardini, A, Nanni, O, Amadori, D, Frassineti, GLP, Sansoni, E, Ragazzini, A, Ruscelli, S, Crivellari, G, Galiano, A, Rodriquenz, MG, Biasini, C, Porzio, R, Pittureri, C, Amaducci, E, Faedi, M, Codecà, C, Crepaldi, F, Pedrazzoli, P, Bramanti, A, Buonadonna, A, Garetto, F, Comandone, A, Giordano, M, Luchena, G, Luzzani, M, Cifatte, C, Pino, MS, Zoccali, S, Cattaneo, MT, Dalu, D, Sozzi, P, Gauna, R, Alquati, S, Costantini, M, Quadrini, S, Narducci, F, Mastromauro, C, Scognamiglio, R, Degiovanni, D, Negri, F, Caraceni, AT & Montanari, L 2016, 'Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial', European Journal of Cancer, vol. 65, pp. 61-68. https://doi.org/10.1016/j.ejca.2016.06.007
Maltoni, Marco Cesare ; Scarpi, Emanuela ; Dall'Agata, Monia ; Zagonel, Vittorina ; Bertè, Raffaella ; Ferrari, Daris ; Broglia, Chiara Maria Giovann ; Bortolussi, Roberto ; Trentin, Leonardo ; Valgiusti, Martina ; Pini, Sara ; Farolfi, Alberto ; Casadei Gardini, Andrea ; Nanni, Oriana ; Amadori, Dino ; Frassineti, Giovanni Luca Paolo ; Sansoni, E. ; Ragazzini, Angela ; Ruscelli, Silvia ; Crivellari, Gino ; Galiano, A. ; Rodriquenz, Maria Grazia ; Biasini, Claudia ; Porzio, Rosa ; Pittureri, Cristina ; Amaducci, E. ; Faedi, Marina ; Codecà, Carla ; Crepaldi, Francesca ; Pedrazzoli, Paolo ; Bramanti, Alfina ; Buonadonna, Angela ; Garetto, Ferdinando ; Comandone, A. ; Giordano, M. ; Luchena, Giovanna ; Luzzani, Massimo ; Cifatte, Chiara ; Pino, M. S. ; Zoccali, Sonia ; Cattaneo, M. T. ; Dalu, Davide ; Sozzi, Pietro ; Gauna, Roberta ; Alquati, Sara ; Costantini, Massimo ; Quadrini, S. ; Narducci, Filomena ; Mastromauro, Cataldo ; Scognamiglio, Rodolfo ; Degiovanni, D. ; Negri, Federica ; Caraceni, Augusto Tommaso ; Montanari, L. / Systematic versus on-demand early palliative care : results from a multicentre, randomised clinical trial. In: European Journal of Cancer. 2016 ; Vol. 65. pp. 61-68.
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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.",
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author = "Maltoni, {Marco Cesare} and Emanuela Scarpi and Monia Dall'Agata and Vittorina Zagonel and Raffaella Bert{\`e} and Daris Ferrari and Broglia, {Chiara Maria Giovann} and Roberto Bortolussi and Leonardo Trentin and Martina Valgiusti and Sara Pini and Alberto Farolfi and {Casadei Gardini}, Andrea and Oriana Nanni and Dino Amadori and Frassineti, {Giovanni Luca Paolo} and E. Sansoni and Angela Ragazzini and Silvia Ruscelli and Gino Crivellari and A. Galiano and Rodriquenz, {Maria Grazia} and Claudia Biasini and Rosa Porzio and Cristina Pittureri and E. Amaducci and Marina Faedi and Carla Codec{\`a} and Francesca Crepaldi and Paolo Pedrazzoli and Alfina Bramanti and Angela Buonadonna and Ferdinando Garetto and A. Comandone and M. Giordano and Giovanna Luchena and Massimo Luzzani and Chiara Cifatte and Pino, {M. S.} and Sonia Zoccali and Cattaneo, {M. T.} and Davide Dalu and Pietro Sozzi and Roberta Gauna and Sara Alquati and Massimo Costantini and S. Quadrini and Filomena Narducci and Cataldo Mastromauro and Rodolfo Scognamiglio and D. Degiovanni and Federica Negri and Caraceni, {Augusto Tommaso} and L. Montanari",
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TY - JOUR

T1 - Systematic versus on-demand early palliative care

T2 - results from a multicentre, randomised clinical trial

AU - Maltoni, Marco Cesare

AU - Scarpi, Emanuela

AU - Dall'Agata, Monia

AU - Zagonel, Vittorina

AU - Bertè, Raffaella

AU - Ferrari, Daris

AU - Broglia, Chiara Maria Giovann

AU - Bortolussi, Roberto

AU - Trentin, Leonardo

AU - Valgiusti, Martina

AU - Pini, Sara

AU - Farolfi, Alberto

AU - Casadei Gardini, Andrea

AU - Nanni, Oriana

AU - Amadori, Dino

AU - Frassineti, Giovanni Luca Paolo

AU - Sansoni, E.

AU - Ragazzini, Angela

AU - Ruscelli, Silvia

AU - Crivellari, Gino

AU - Galiano, A.

AU - Rodriquenz, Maria Grazia

AU - Biasini, Claudia

AU - Porzio, Rosa

AU - Pittureri, Cristina

AU - Amaducci, E.

AU - Faedi, Marina

AU - Codecà, Carla

AU - Crepaldi, Francesca

AU - Pedrazzoli, Paolo

AU - Bramanti, Alfina

AU - Buonadonna, Angela

AU - Garetto, Ferdinando

AU - Comandone, A.

AU - Giordano, M.

AU - Luchena, Giovanna

AU - Luzzani, Massimo

AU - Cifatte, Chiara

AU - Pino, M. S.

AU - Zoccali, Sonia

AU - Cattaneo, M. T.

AU - Dalu, Davide

AU - Sozzi, Pietro

AU - Gauna, Roberta

AU - Alquati, Sara

AU - Costantini, Massimo

AU - Quadrini, S.

AU - Narducci, Filomena

AU - Mastromauro, Cataldo

AU - Scognamiglio, Rodolfo

AU - Degiovanni, D.

AU - Negri, Federica

AU - Caraceni, Augusto Tommaso

AU - Montanari, L.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - 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.

AB - 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.

KW - Early palliative care

KW - Quality of care

KW - Quality of life

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