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早期及系统的姑息治疗整合对晚期癌症患者的效果:一项随机对照试验。

Effect of early and systematic integration of palliative care in patients with advanced cancer: a randomised controlled trial.

机构信息

End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Brussels, Belgium.

End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Brussels, Belgium.

出版信息

Lancet Oncol. 2018 Mar;19(3):394-404. doi: 10.1016/S1470-2045(18)30060-3. Epub 2018 Feb 3.

DOI:10.1016/S1470-2045(18)30060-3
PMID:29402701
Abstract

BACKGROUND

The benefit of early integration of palliative care into oncological care is suggested to be due to increased psychosocial support. In Belgium, psychosocial care is part of standard oncological care. The aim of this randomised controlled trial is to examine whether early and systematic integration of palliative care alongside standard psychosocial oncological care provides added benefit compared with usual care.

METHODS

In this randomised controlled trial, eligible patients were 18 years or older, and had advanced cancer due to a solid tumour, an European Cooperative Oncology Group performance status of 0-2, an estimated life expectancy of 12 months, and were within the first 12 weeks of a new primary tumour or had a diagnosis of progression. Patients were randomly assigned (1:1), by block design using a computer-generated sequence, either to early and systematic integration of palliative care into oncological care, or standard oncological care alone in a setting where all patients are offered multidisciplinary oncology care by medical specialists, psychologists, social workers, dieticians, and specialist nurses. The primary endpoint was change in global health status/quality of life scale assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ C30) at 12 weeks. The McGill Quality of Life Questionnaire (MQOL), which includes the additional existential wellbeing dimension, was also used. Analysis was by intention to treat. This trial is ongoing, but closed for accrual, and is registered with ClinicalTrials.gov, number NCT01865396.

FINDINGS

From April 29, 2013, to Feb 29, 2016, we screened 468 patients for eligibility, of whom 186 were enrolled and randomly assigned to the early and systematic palliative care group (92 patients) or the standard oncological care group (94). Compliance at 12 weeks was 71% (65 patients) in the intervention group versus 72% (68) in the control group. The overall quality of life score at 12 weeks, by the EORTC QLQ C30, was 54·39 (95% CI 49·23-59·56) in the standard oncological care group versus 61·98 (57·02-66·95) in the early and systematic palliative care group (difference 7·60 [95% CI 0·59-14·60]; p=0·03); and by the MQOL Single Item Scale, 5·94 (95% CI 5·50-6·39) in the standard oncological care group versus 7·05 (6·59-7·50) in the early and systematic palliative care group (difference 1·11 [95% CI 0·49-1·73]; p=0.0006).

INTERPRETATION

The findings of this study show that a model of early and systematic integration of palliative care in oncological care increases the quality of life of patients with advanced cancer. Our findings also show that early and systematic integration of palliative care is more beneficial for patients with advanced cancer than palliative care consultations offered on demand, even when psychosocial support has already been offered. Through integration of care, oncologists and specialised palliative care teams should work together to enhance the quality of life of patients with advanced cancer.

FUNDING

Research Foundation Flanders, Flemish Cancer Society (Kom Op Tegen Kanker).

摘要

背景

早期将姑息治疗纳入肿瘤治疗的益处被认为是由于增加了心理社会支持。在比利时,心理社会护理是标准肿瘤护理的一部分。本随机对照试验的目的是检验在标准肿瘤心理社会护理的基础上,早期和系统地整合姑息治疗是否比常规护理提供了额外的益处。

方法

在这项随机对照试验中,合格的患者年龄在 18 岁或以上,患有晚期实体瘤,欧洲癌症研究与治疗组织(ECOG)体能状态为 0-2,预计生存期为 12 个月,且处于新原发性肿瘤的前 12 周内,或诊断为进展。患者被随机分配(1:1),采用计算机生成的序列进行分组,分为早期和系统地将姑息治疗纳入肿瘤治疗组,或标准肿瘤治疗组,在所有患者都接受由医学专家、心理学家、社会工作者、营养师和专科护士提供的多学科肿瘤护理的环境中。主要终点是在 12 周时使用欧洲癌症研究与治疗组织生存质量问卷核心 30 项(EORTC QLQ C30)评估的全球健康状况/生活质量量表的变化。还使用了包括额外存在幸福感维度的麦吉尔生活质量问卷(MQOL)。分析采用意向治疗。该试验正在进行中,但已停止入组,并在 ClinicalTrials.gov 注册,编号为 NCT01865396。

结果

从 2013 年 4 月 29 日至 2016 年 2 月 29 日,我们对 468 名患者进行了资格筛选,其中 186 名患者入选并随机分配到早期和系统姑息治疗组(92 名患者)或标准肿瘤治疗组(94 名患者)。干预组在 12 周时的依从率为 71%(65 名患者),对照组为 72%(68 名)。根据 EORTC QLQ C30,12 周时的整体生活质量评分在标准肿瘤治疗组为 54.39(95%CI 49.23-59.56),在早期和系统姑息治疗组为 61.98(57.02-66.95)(差异为 7.60[95%CI 0.59-14.60];p=0.03);根据 MQOL 单项量表,标准肿瘤治疗组为 5.94(95%CI 5.50-6.39),早期和系统姑息治疗组为 7.05(6.59-7.50)(差异为 1.11[95%CI 0.49-1.73];p=0.0006)。

结论

本研究的结果表明,早期和系统地将姑息治疗纳入肿瘤治疗模式可提高晚期癌症患者的生活质量。我们的研究结果还表明,与按需提供的姑息治疗咨询相比,早期和系统地整合姑息治疗对晚期癌症患者更有益,即使已经提供了心理社会支持。通过整合护理,肿瘤学家和专业姑息治疗团队应共同努力,提高晚期癌症患者的生活质量。

资金

佛兰芒研究基金会,佛兰芒癌症协会(Kom Op Tegen Kanker)。

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