Department of Palliative Medicine, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Palliative Therapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Cancer Med. 2024 Nov;13(22):e70325. doi: 10.1002/cam4.70325.
We aimed to examine the effectiveness of a nurse-led, screening-triggered early specialized palliative care intervention program for patients with advanced lung cancer.
Patients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced-level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end-points were TOI scores at week 20, depression, anxiety, and survival.
In total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: -0.70, 4.95; p = 0.107, one-sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302).
Nurse-led, screening-triggered, early specialized palliative care did not show significant superiority over usual care during the 12-week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice.
The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491.
本研究旨在评估一种护士主导的、基于筛查的早期专科姑息治疗干预方案对晚期肺癌患者的疗效。
2017 年 1 月至 2019 年 9 月期间,对接受初始化疗的晚期肺癌患者进行分组,随机分为干预组和常规护理组。干预组由高级护士进行全面需求评估、咨询和服务协调。常规护理组接受常规肿瘤护理。主要终点为从基线到 12 周时试验结局指标(TOI)评分的变化。次要终点为第 20 周时的 TOI 评分、抑郁、焦虑和生存情况。
共有 102 例患者被分配到每组。与常规护理组相比,干预组在 12 周时 TOI 评分无显著改善(平均组间差异:2.13;90%置信区间:-0.70,4.95;p=0.107,单侧),而在 20 周时显著改善(3.58;90%置信区间:0.15,7.00;p=0.043)。从基线到第 12 周和第 20 周,两组的抑郁和焦虑评分变化均无显著差异(抑郁:p=0.60 和 0.10,焦虑:p=0.78 和 0.067)。两组的生存时间无显著差异(中位生存时间:12.1 个月比 11.1 个月;p=0.302)。
在 12 周的研究期间,护士主导的、基于筛查的早期专科姑息治疗并未显示出比常规护理有显著优势。然而,它可能产生了延迟的临床获益,如生活质量的改善,这种可行的模式在临床实践中是可以接受的。
日本大学医院医学信息网络临床试验注册:UMIN000025491。