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Randomized Controlled Trial
. 2019 Jul;27(7):2425-2434.
doi: 10.1007/s00520-018-4517-2. Epub 2018 Oct 24.

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

Emanuela Scarpi  1 , Monia Dall'Agata  2 , Vittorina Zagonel  3 , Teresa Gamucci  4 , Raffaella Bertè  5 , Elisabetta Sansoni  6 , Elena Amaducci  7 , Chiara Maria Broglia  8 , Sara Alquati  9 , Ferdinando Garetto  10 , Stefania Schiavon  3 , Silvia Quadrini  4 , Elena Orlandi  11 , Andrea Casadei Gardini  12 , Silvia Ruscelli  12 , Daris Ferrari  13 , Maria Simona Pino  14 , Roberto Bortolussi  15 , Federica Negri  16 , Silvia Stragliotto  3 , Filomena Narducci  4 , Martina Valgiusti  12 , Alberto Farolfi  12 , Oriana Nanni  2 , Romina Rossi  6 , Marco Maltoni  6 ; Early Palliative Care Italian Study Group (EPCISG)
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Free article
Randomized Controlled Trial

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

Emanuela Scarpi et al. Support Care Cancer. 2019 Jul.
Free article

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).

Keywords: Aggressiveness in end of life; Early palliative care; Quality of care; Quality of life.

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