Abstract
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. 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 (12weeks 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. 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. 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. ClinicalTrials.gov (NCT01996540).
Highlights
Materials and methodsThe most recent World Health Organization (WHO) definition of palliative care (PC) states that PC Bis applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy^ [1]
PC is divided into end of life (EoL) PC and early palliative care (EPC), the latter referring to PC performed alongside rather than at the end of antineoplastic therapies [2]
An evaluation of prognosis is needed before referring patients for EoL-PC, whereas EPC requires an assessment of the PC needs of patients [5, 6]
Summary
Materials and methodsThe most recent World Health Organization (WHO) definition of palliative care (PC) states that PC Bis applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy^ [1]. PC is divided into end of life (EoL) PC and early palliative care (EPC), the latter referring to PC performed alongside rather than at the end of antineoplastic therapies [2]. The weight of PC intervention is dependent on primary care oncologists accepting to share the decision-making process with their palliative care colleagues [12]. In such circumstances, there is a risk of contamination from the standard PC arm (crossover) and/or compensation, the latter defined as a higher level of competence in PC needs by the attending oncologists [13]. EPC has been studied and has shown varying degrees of efficacy in outcomes concerning quality of life (QoL), quality of care, and healthcare costs [14]
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