Bakitas Marie, Lyons Kathleen Doyle, Hegel Mark T, Balan Stefan, Brokaw Frances C, Seville Janette, Hull Jay G, Li Zhongze, Tosteson Tor D, Byock Ira R, Ahles Tim A
Department of Anesthesiology, Section of Palliative Medicine, Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA.
JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer.
To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer.
DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont.
A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161).
Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record.
A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups.
Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits.
clinicaltrials.gov Identifier: NCT00253383.
关于姑息治疗干预措施改善晚期癌症患者护理效果的随机对照试验较少。
确定以护士为主导的干预措施对晚期癌症患者生活质量、症状强度、情绪和资源利用的影响。
设计、地点和参与者：2003年11月至2008年5月在新罕布什尔州一家农村地区、由美国国立癌症研究所指定的综合癌症中心及其附属外展诊所，以及佛蒙特州一家退伍军人事务医疗中心对322例晚期癌症患者进行的随机对照试验。
由高级执业护士实施的多成分心理教育干预（ENABLE项目[在生命终结前进行教育、培养、建议]），包括4次每周一次的教育课程和每月一次的随访课程，直至死亡或研究结束（n = 161），与常规护理（n = 161）进行对比。
生活质量通过姑息治疗慢性疾病功能评估量表进行测量（评分范围为0 - 184）。症状强度通过埃德蒙顿症状评估量表进行测量（评分范围为0 - 900）。情绪通过流行病学研究中心抑郁量表进行测量（范围为0 - 60）。这些指标在基线、1个月时以及之后每3个月评估一次，直至死亡或研究结束。服务强度通过电子病历中记录的住院天数、重症监护病房（ICU）住院天数以及急诊科就诊次数进行测量。
共有322例胃肠道癌症患者（41%；常规护理组67例，干预组66例）、肺癌患者（36%；58例对59例）、泌尿生殖系统癌症患者（12%；20例对19例）和乳腺癌患者（10%；16例对17例）被随机分组。所有参与者的估计治疗效果（干预组减去常规护理组）为，生活质量平均（标准误）提高4.6（2）（P = .02），症状强度降低27.8（15）（P = .06），抑郁情绪降低1.8（0.81）（P = .02）。研究期间死亡的参与者的估计治疗效果为，生活质量平均（标准误）提高8.6（3.6）（P = .02），症状强度降低24.2（20.5）（P = .24），抑郁情绪降低2.7（1.2）（P = .03）。两组的服务强度没有差异。
与接受常规肿瘤护理的参与者相比，接受以护士为主导、以姑息治疗为重点、同时涉及身体、心理社会和护理协调的干预措施并结合肿瘤护理的参与者，生活质量和情绪得分更高，但症状强度评分没有改善，住院天数、ICU住院天数或急诊科就诊次数也没有减少。
clinicaltrials.gov标识符：NCT00253383。
