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首页> 外文期刊>Palliative medicine >Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial
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Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial

机译:早期专业姑息治疗的随机临床试验加标准护理与患有先进癌症患者的标准护理:丹麦姑息治疗试验

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Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient’s primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0–100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (?4.9 points (95% confidence interval ?11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.
机译:背景:早期姑息治疗的有益效果已在晚期癌症中发现,但证据不是明确的。目的:探讨肿瘤内核查患者早期专业姑息治疗的效果。设定/参与者:丹麦姑息治疗试验(DANPACT)(CLINCOLTRIAMS.GOV NCT01348048)是一种多期式随机临床试验,比较专业姑息治疗团队加上标准护理与单独的标准护理。计划的样品大小为300.在五个肿瘤学部门,连续癌症患者被筛查用于姑息性需求。评分超过了物理,情绪或角色功能,或恶心/呕吐,疼痛,呼吸困难或缺乏食欲的预定义的阈值,根据欧洲研究和治疗癌症质量问卷(EORTC QLQ-C30)有资格。主要结果是每位患者的主要需求(最严重的七个QLQ-C30尺度)的变化在3和8周的后续行动(0-100级)。进行了五种敏感性分析。七QLQ-C30尺度和生存中的二次结果是变化。结果:共有145名患者随机随机分配到早期专业姑息治疗与标准护理。早期专业姑息治疗对主要需求变化的主要结果没有影响(?4.9点(95%置信区间?11.3至+1.5点); p = 0.14)。敏感性分析显示出类似的结果。分析二次结果,包括存活,也没有差异,也可能除了恶心/呕吐之外,早期专业姑息治疗可能具有有益效果。结论:我们没有观察早期专业姑息治疗的有益或有害影响,但不能排除重要的有益效果。

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