The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial

Nurses play an important role in providing palliative care. However, few studies have evaluated the effectiveness of nurse-led primary palliative care. To evaluate the effect of nurse-led enhanced supportive care as an early primary palliative care approach for advanced cancer patients. Randomized controlled trial. This study was conducted at Yonsei Cancer Center in Seoul, Korea. Advanced cancer patients initiating palliative chemotherapy (N = 258) and their family caregivers (N = 120) were enrolled and completed 3-month (n = 182 patients, n = 79 caregivers) and 6-month (n = 141 patients, n = 60 caregivers) follow-up assessments. Participants were randomly assigned to the intervention or control group (1:1). The intervention group received nurse-led enhanced supportive care, which included symptom management and coping enhancement counseling before each chemotherapy cycle (baseline to 3 months) and was delivered by trained nurses. The control group received symptom monitoring. Family caregivers only participated in the evaluation. The primary outcomes were quality of life (EORTC-QLQ C30), symptoms (ESAS), and coping (Brief COPE) at 3 months. The secondary outcomes were quality of life, symptoms, and coping at 6 months. Self-efficacy for coping with cancer (CBI-3.0 K), and depression among cancer patients and family caregivers (HADS-D) at 3 and 6 months were also evaluated. The data were analyzed using linear mixed models. The intervention group reported beneficial effects in the following outcomes: 1) Quality of life [role functioning domain at 3 months (1.01 ± 2.34 vs. -8.37 ± 2.07; p = .003 [-15.57, -3.18]; adjusted p = .044), 2) coping [active coping at 3 months (0.27 ± 0.16 vs. -0.34 ± 0.14; p = .006 [-1.04, -0.18]; adjusted p = .044), and self-distraction (0.22 ± 0.17 vs. -0.42 ± 0.15; p = .004 [-1.08, -0.20]; adjusted p = .044) at 3 months]; 3) self-efficacy in coping with cancer [maintaining activity and independence at 3 months (1.45 ± 0.47 vs. -0.31 ± 0.42; p = .006 [-2.99, -0.52]; adjusted p = .044)]. The intervention was not effective in reducing symptoms and depression of patients or depression of caregivers (adjusted p > .05). Nurse-led enhanced supportive care as an early primary palliative care approach has demonstrated effectiveness in improving the role functioning domain of quality of life, use of coping strategies, and self-efficacy in maintaining activity and independence among advanced cancer patients. Nurse-led early primary palliative care should be delivered by trained nurses and incorporated into routine oncology practice. Registered at ClinicalTrials.gov, NCT04407013, on May 29, 2020, https://www. gov/ct2/show/study/NCT04407013. The protocol version is ESC 1.0. The integration of nurse-led early primary palliative care into routine oncology practice for patients with advanced cancer is recommended.