Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes

Early Palliative Care Italian Study Group (EPCISG), 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 & 7 others Silvia Stragliotto, Filomena Narducci, Martina Valgiusti, Alberto Farolfi, Oriana Nanni, Romina Rossi, Marco Maltoni

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Abstract

PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).
Original languageEnglish
JournalSupportive Care in Cancer
DOIs
Publication statusPublished - Oct 24 2018

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Palliative Care
Stomach Neoplasms
Randomized Controlled Trials
Delivery of Health Care
Quality of Health Care
Quality of Life
Standard of Care
Random Allocation
Health Care Costs
Patient Selection
Multicenter Studies
Neoplasms
Decision Making
Outcome Assessment (Health Care)
Prospective Studies
Physicians
Survival

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Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. / (EPCISG), Early Palliative Care Italian Study Group; Scarpi, Emanuela; Dall'Agata, Monia; Zagonel, Vittorina; Gamucci, Teresa; Bertè, Raffaella; Sansoni, Elisabetta; Amaducci, Elena; Broglia, Chiara Maria; Alquati, Sara; Garetto, Ferdinando; Schiavon, Stefania; Quadrini, Silvia; Orlandi, Elena; Casadei Gardini, Andrea; Ruscelli, Silvia; Ferrari, Daris; Pino, Maria Simona; Bortolussi, Roberto; Negri, Federica; Stragliotto, Silvia; Narducci, Filomena; Valgiusti, Martina; Farolfi, Alberto; Nanni, Oriana; Rossi, Romina; Maltoni, Marco.

In: Supportive Care in Cancer, 24.10.2018.

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(EPCISG), Early Palliative Care Italian Study Group ; Scarpi, Emanuela ; Dall'Agata, Monia ; Zagonel, Vittorina ; Gamucci, Teresa ; Bertè, Raffaella ; Sansoni, Elisabetta ; Amaducci, Elena ; Broglia, Chiara Maria ; Alquati, Sara ; Garetto, Ferdinando ; Schiavon, Stefania ; Quadrini, Silvia ; Orlandi, Elena ; Casadei Gardini, Andrea ; Ruscelli, Silvia ; Ferrari, Daris ; Pino, Maria Simona ; Bortolussi, Roberto ; Negri, Federica ; Stragliotto, Silvia ; Narducci, Filomena ; Valgiusti, Martina ; Farolfi, Alberto ; Nanni, Oriana ; Rossi, Romina ; Maltoni, Marco. / Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. In: Supportive Care in Cancer. 2018.
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abstract = "PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95{\%} CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95{\%} CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).",
author = "(EPCISG), {Early Palliative Care Italian Study Group} and Emanuela Scarpi and Monia Dall'Agata and Vittorina Zagonel and Teresa Gamucci and Raffaella Bert{\`e} and Elisabetta Sansoni and Elena Amaducci and Broglia, {Chiara Maria} and Sara Alquati and Ferdinando Garetto and Stefania Schiavon and Silvia Quadrini and Elena Orlandi and {Casadei Gardini}, Andrea and Silvia Ruscelli and Daris Ferrari and Pino, {Maria Simona} and Roberto Bortolussi and Federica Negri and Silvia Stragliotto and Filomena Narducci and Martina Valgiusti and Alberto Farolfi and Oriana Nanni and Romina Rossi and Marco Maltoni",
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T1 - Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes

AU - (EPCISG), Early Palliative Care Italian Study Group

AU - Scarpi, Emanuela

AU - Dall'Agata, Monia

AU - Zagonel, Vittorina

AU - Gamucci, Teresa

AU - Bertè, Raffaella

AU - Sansoni, Elisabetta

AU - Amaducci, Elena

AU - Broglia, Chiara Maria

AU - Alquati, Sara

AU - Garetto, Ferdinando

AU - Schiavon, Stefania

AU - Quadrini, Silvia

AU - Orlandi, Elena

AU - Casadei Gardini, Andrea

AU - Ruscelli, Silvia

AU - Ferrari, Daris

AU - Pino, Maria Simona

AU - Bortolussi, Roberto

AU - Negri, Federica

AU - Stragliotto, Silvia

AU - Narducci, Filomena

AU - Valgiusti, Martina

AU - Farolfi, Alberto

AU - Nanni, Oriana

AU - Rossi, Romina

AU - Maltoni, Marco

PY - 2018/10/24

Y1 - 2018/10/24

N2 - PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).

AB - PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).

U2 - 10.1007/s00520-018-4517-2

DO - 10.1007/s00520-018-4517-2

M3 - Article

JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

SN - 0941-4355

ER -