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

• Published in: Supportive care in cancer Vol. 27; no. 7; pp. 2425 - 2434
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-07-2019; Springer; Springer Nature B.V
• Subjects: Cancer; Cancer patients; Care and treatment; Clinical trials; Evidence-based medicine; Gastric cancer; Medical care; Medical care, Cost of; Medicine; Medicine & Public Health; Nursing; Nursing Research; Oncology; Oncology, Experimental; Original Article; Pain Medicine; Palliative care; Palliative treatment; Patient outcomes; Patients; Quality management; Quality of care; Rehabilitation Medicine; Stomach cancer; Early palliative care; Aggressiveness in end of life; Quality of care; Quality of life
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-018-4517-2

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).