Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial
Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial
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DOI：
10.1200/jco.2014.58.6362
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发表时间：
2015-05-01
影响因子：
45.3
通讯作者：
Ahles, Tim A.
中科院分区：
文献类型：
--
作者：
Bakitas, Marie A.;Tosteson, Tor D.;Ahles, Tim A.
目的
随机对照试验支持肿瘤学与姑息治疗（PC）相结合；然而，最佳时机尚未得到评估。我们研究了早期与延迟PC对生活质量（QOL）、症状影响、情绪、1年生存率以及资源利用的影响。
患者与方法
在2010年10月至2013年3月期间，美国国家癌症研究所癌症中心、退伍军人事务医疗中心以及社区外展诊所的207名晚期癌症患者被随机分配在入组后早期或3个月后接受当面的PC咨询、结构化的PC远程医疗护士辅导课程（每周一次，共六次）以及每月随访。结果指标包括生活质量、症状影响、情绪、1年生存率以及资源利用（住院/重症监护病房天数、急诊室就诊次数、过去14天内的化疗情况以及死亡地点）。
结果
总体而言，患者报告的结果在入组后（生活质量，P = 0.34；症状影响，P = 0.09；情绪，P = 0.33）或死亡前（生活质量，P = 0.73；症状影响，P = 0.30；情绪，P = 0.82）均无统计学意义。卡普兰 - 迈耶1年生存率在早期组为63%，在延迟组为48%（差异为15%；P = 0.038）。早期与延迟死亡患者的资源利用相对比率在住院天数（0.73；95%置信区间，0.41 - 1.27；P = 0.26）、重症监护病房天数（0.68；95%置信区间，0.23 - 2.02；P = 0.49）、急诊室就诊次数（0.73；95%置信区间，0.45 - 1.19；P = 0.21）、过去14天内的化疗情况（1.57；95%置信区间，0.37 - 6.7；P = 0.27）以及在家中死亡（27例[54%]对28例[47%]；P = 0.60）方面相似。
结论
早期入组参与者的患者报告结果和资源利用在统计学上无差异；然而，与3个月后开始的患者相比，他们入组1年后的生存率有所提高。了解PC可能提高生存率的复杂机制仍然是一项重要的研究重点。
PurposeRandomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use.Patients and MethodsBetween October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location).ResultsOverall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60).ConclusionEarly-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.