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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

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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).

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Acknowledgements

The authors thank the following members of the Early Palliative Care Italian Study Group and co-authors of the paper for their technical help: Flavia Pagan (IRST IRCCS, Meldola), Vincenzo Dadduzio (Veneto Institute of Oncology IOV-IRCCS, Padus), Tiziana Trapasso (SS Trinità Hospital, Sora, ASL Frosinone), Camilla Di Nunzio (Guglielmo da Saliceto Hospital, Piacenza), Paolo Pedrazzoli (Fondazione IRCCS Policlinico San Matteo, Pavia), Cristina Autelitano (Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia), Alessandro Comandone (Presidio Humanitas Gradenigo, Turin), Carla Codecà (San Paolo Hospital, Milan), Francesca Martella (Azienda USL Toscana Centro, S. Maria Annunziata Hospital, Florence), Angela Buonadonna (Aviano National Cancer Institute, Aviano), Laura Toppo (Azienda Socio Sanitaria Territoriale, Cremona), Augusto Caraceni (Fondazione IRCCS Istituto Nazionale dei Tumori, Milan), Giovanni Luchena (Sant’Anna Hospital, Asst-Lariana, Como), Maria Teresa Cattaneo (L. Sacco Hospital, Milan), Massimo Luzzani (E.O. Galliera Hospitals, Genoa), Roberta Gauna (Ospedale degli Infermi, Ponderano), and Cristina Pittureri (AUSL Romagna, Cesena). The authors also thank Grainne Tierney and Cristiano Verna for editorial assistance.

Funding

This trial was partially supported by a research grant from the Italian Ministry of Health (RF-2011-02350971).

Author information

Authors and Affiliations

  1. Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via P. Maroncelli 40, 47014, Meldola, FC, Italy

    Emanuela Scarpi, Monia Dall’Agata & Oriana Nanni

  2. Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy

    Vittorina Zagonel, Stefania Schiavon & Silvia Stragliotto

  3. Oncology Unit, SS Trinità Hospital, Sora, ASL Frosinone, Italy

    Teresa Gamucci, Silvia Quadrini & Filomena Narducci

  4. Palliative Care, Oncology Department, Guglielmo da Saliceto Hospital, AUSL, Piacenza, Italy

    Raffaella Bertè

  5. Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei, Tumori (IRST) IRCCS, Meldola, Italy

    Elisabetta Sansoni, Romina Rossi & Marco Maltoni

  6. Palliative Care and Hospice Unit, AUSL Romagna, Cesena, Italy

    Elena Amaducci

  7. Oncology Unit, Fondazione IRCCS, Policlinico San Matteo, Pavia, Italy

    Chiara Maria Broglia

  8. Palliative Care Unit, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy

    Sara Alquati

  9. Medical Oncology Unit, Presidio Humanitas Gradenigo, Torino, Italy

    Ferdinando Garetto

  10. Medical Oncology Unit, Oncology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy

    Elena Orlandi

  11. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

    Andrea Casadei Gardini, Silvia Ruscelli, Martina Valgiusti & Alberto Farolfi

  12. Oncology Unit, San Paolo Hospital, Milan, Italy

    Daris Ferrari

  13. Medical Oncology Unit, Oncology Department, Azienda USL Toscana Centro, S. Maria Annunziata Hospital, Florence, Italy

    Maria Simona Pino

  14. Palliative care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy

    Roberto Bortolussi

  15. Medical Oncology Unit, Azienda Socio Sanitaria Territoriale, Cremona, Italy

    Federica Negri

Authors
  1. Emanuela Scarpi
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  2. Monia Dall’Agata
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  3. Vittorina Zagonel
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  4. Teresa Gamucci
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  5. Raffaella Bertè
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  6. Elisabetta Sansoni
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  7. Elena Amaducci
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  8. Chiara Maria Broglia
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  9. Sara Alquati
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  10. Ferdinando Garetto
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  11. Stefania Schiavon
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  12. Silvia Quadrini
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  13. Elena Orlandi
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  14. Andrea Casadei Gardini
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  15. Silvia Ruscelli
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  16. Daris Ferrari
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  17. Maria Simona Pino
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  18. Roberto Bortolussi
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  19. Federica Negri
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  20. Silvia Stragliotto
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  21. Filomena Narducci
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  22. Martina Valgiusti
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  23. Alberto Farolfi
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  24. Oriana Nanni
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  25. Romina Rossi
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  26. Marco Maltoni
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Consortia

on behalf of the Early Palliative Care Italian Study Group (EPCISG)

Contributions

Conception and design: Marco Maltoni, Emanuela Scarpi, Chiara Maria Broglia, and Oriana Nanni. Collection and assembly of data: 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, Silvia Stragliotto, Filomena Narducci, Martina Valgiusti, Alberto Farolfi, Oriana Nanni, Romina Rossi, and Marco Maltoni. Data analysis and interpretation: Marco Maltoni and Emanuela Scarpi. Manuscript writing: All authors. Final approval of manuscript: All authors and members of the Early Palliative Care Italian Study Group.

Corresponding author

Correspondence to Emanuela Scarpi.

Ethics declarations

The study was approved by the Ethics Committee of each participating center and was performed in accordance with the principles laid down in the 1964 Declaration of Helsinki and its later amendments.

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

Written informed consent was obtained from all individuals taking part in the study.

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Scarpi, E., Dall’Agata, M., Zagonel, V. et al. Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes. Support Care Cancer 27, 2425–2434 (2019). https://doi.org/10.1007/s00520-018-4517-2

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