DataSheet_1_Combined early palliative care for non-small-cell lung cancer patients: a randomized controlled trial in Chongqing, China.pdf

PurposeMore effective approaches are needed to improve the prognosis of non-small-cell lung cancer (NSCLC) patients. Thus, we used the E-warm model to assess how early integration of interdisciplinary palliative care was related to the quality of life (QoL), psychological functioning, pain management, and nutrition factors of NSCLC patients.
MethodsThis randomized controlled trial enrolled 280 newly diagnosed NSCLC patients, which were randomly divided (1:1) into combined early palliative care (CEPC) and standard oncological care (SC) groups. At baseline and after 24 weeks, the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, Hospital Anxiety and Depression Scale (HADS), and the Patient Health Questionnaire-9 (PHQ-9) were used to assess QoL and psychological function, respectively. The Numerical Rating Scale (NRS) and Patient-Generated Subjective Global Assessment (PG-SGA) were used to assess cancer patients’ pain and nutrition levels. The primary outcome was overall survival (OS). Secondary outcomes comprised changes in the QoL, psychological functioning, pain, and nutrition state. The intention-to-treat method was applied for analysis. This study was registered at www.chictr.org.cn (ChiCTR2200062617).
ResultsOf the 140 patients enrolled in the CEPC and SC groups, 102 and 82 completed the research. The CEPC group presented higher QoL than the SC group (p < 0.05). Additionally, fewer patients presented depressive symptoms in the CEPC group than in the SC group (p < 0.05), as well as better nutritional status (p = 0.007) and pain management (p = 0.003). Compared to the SC group, CEPC patients had significantly longer OS (20.4 vs. 24.6 months, p = 0.042; HR: 0.19; 95% CI: 0.04-0.85, p = 0.029).
ConclusionWith combined early palliative care, NSCLC patients lived longer, had better QoL, were psychologically stable, were in less pain, and were more nutritionally satisfied.

研究背景：目前亟需更有效的手段以改善非小细胞肺癌（non-small-cell lung cancer, NSCLC）患者的预后。为此，本研究采用E-warm模型，评估早期整合多学科姑息治疗与非小细胞肺癌患者的生活质量（quality of life, QoL）、心理功能、疼痛控制及营养状况的相关性。
研究方法：本随机对照试验共纳入280例初诊非小细胞肺癌患者，按1:1比例随机分为联合早期姑息治疗（combined early palliative care, CEPC）组与标准肿瘤治疗（standard oncological care, SC）组。分别于基线及第24周时，采用癌症治疗功能评价量表-肺癌版（Functional Assessment of Cancer Therapy-Lung, FACT-L）、医院焦虑抑郁量表（Hospital Anxiety and Depression Scale, HADS）以及患者健康问卷-9（Patient Health Questionnaire-9, PHQ-9）评估患者的生活质量与心理功能；采用数字疼痛评分量表（Numerical Rating Scale, NRS）与患者主观整体营养评估量表（Patient-Generated Subjective Global Assessment, PG-SGA）评估患者的疼痛程度与营养水平。本研究的主要结局指标为总生存期（overall survival, OS），次要结局指标包括生活质量、心理功能、疼痛及营养状态的变化。分析采用意向性治疗（intention-to-treat）原则。本研究已在中国临床试验注册中心（www.chictr.org.cn）注册，注册号为ChiCTR2200062617。
研究结果：联合早期姑息治疗组与标准肿瘤治疗组各纳入140例患者，最终分别有102例与82例完成本研究的随访与评估。联合早期姑息治疗组患者的生活质量显著高于标准肿瘤治疗组（p < 0.05）。此外，联合早期姑息治疗组出现抑郁症状的患者比例显著低于标准肿瘤治疗组（p < 0.05），且营养状态更佳（p = 0.007），疼痛控制效果更优（p = 0.003）。与标准肿瘤治疗组相比，联合早期姑息治疗组患者的总生存期显著更长（20.4 vs. 24.6个月，p = 0.042；风险比（Hazard Ratio, HR）：0.19；95%置信区间（95% CI）：0.04~0.85，p = 0.029）。
研究结论：对于非小细胞肺癌患者，联合早期姑息治疗可延长其总生存期，改善生活质量，稳定心理状态，减轻疼痛程度并优化营养状况。