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

Autor: Scarpi E; 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@irst.emr.it., Dall'Agata M; 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., Zagonel V; Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Gamucci T; Oncology Unit, SS Trinità Hospital, Sora, ASL Frosinone, Italy., Bertè R; Palliative Care, Oncology Department, Guglielmo da Saliceto Hospital, AUSL, Piacenza, Italy., Sansoni E; Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei, Tumori (IRST) IRCCS, Meldola, Italy., Amaducci E; Palliative Care and Hospice Unit, AUSL Romagna, Cesena, Italy., Broglia CM; Oncology Unit, Fondazione IRCCS, Policlinico San Matteo, Pavia, Italy., Alquati S; Palliative Care Unit, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy., Garetto F; Medical Oncology Unit, Presidio Humanitas Gradenigo, Torino, Italy., Schiavon S; Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Quadrini S; Oncology Unit, SS Trinità Hospital, Sora, ASL Frosinone, Italy., Orlandi E; Medical Oncology Unit, Oncology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy., Casadei Gardini A; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Ruscelli S; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Ferrari D; Oncology Unit, San Paolo Hospital, Milan, Italy., Pino MS; Medical Oncology Unit, Oncology Department, Azienda USL Toscana Centro, S. Maria Annunziata Hospital, Florence, Italy., Bortolussi R; Palliative care and Pain Therapy Unit, Aviano National Cancer Institute, Aviano, Italy., Negri F; Medical Oncology Unit, Azienda Socio Sanitaria Territoriale, Cremona, Italy., Stragliotto S; Medical Oncology Unit 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy., Narducci F; Oncology Unit, SS Trinità Hospital, Sora, ASL Frosinone, Italy., Valgiusti M; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Farolfi A; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Nanni O; 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., Rossi R; Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei, Tumori (IRST) IRCCS, Meldola, Italy., Maltoni M; Palliative Care Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei, Tumori (IRST) IRCCS, Meldola, Italy.
Jazyk: angličtina
Zdroj: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [Support Care Cancer] 2019 Jul; Vol. 27 (7), pp. 2425-2434. Date of Electronic Publication: 2018 Oct 24.
DOI: 10.1007/s00520-018-4517-2
Abstrakt: 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).
Databáze: MEDLINE
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