Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.
Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.
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DOI：
10.1136/bmjopen-2021-057591
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发表时间：
2022-02-10
期刊：
影响因子：
2.9
通讯作者：
Temel JS
中科院分区：
文献类型：
--
作者：
Post KE;Heuer LB;Kamal AH;Kumar P;Elyze M;Griffith S;Han J;Friedman F;Jackson A;Trotter C;Plotke R;Vyas C;Jackson V;Rabideau DJ;Greer JA;Temel JS
在严重癌症患者的病程早期整合姑息治疗(PC)可以改善他们的预后，并被美国临床肿瘤学会等国家组织推荐。然而，由于缺乏训练有素的PC临床医生和资源，从诊断时起每月访问PC临床医生可能会对实施构成挑战。因此，我们开发了一种分级护理模式，根据患者的需求对PC服务进行分类。我们正在进行一项非盲目随机试验，以评估阶梯式PC模型与早期集成PC模型在改善患者24周生活质量(QOL)方面的非劣性(主要结果)。被分配到早期集成PC的患者在整个疾病过程中每4周与PC会面一次。被分配到阶梯式PC的患者只有在他们疾病的临床重要时刻(如癌症进展)才会去看PC，除非他们的生活质量下降，在这段时间里，他们会被提升，并在疾病的剩余时间内每4周与PC会面一次。次要目标包括评估阶梯式PC在临终关怀和临终关怀住院时间方面是否不逊于早期集成PC，以及比较资源利用情况。患者来自马萨诸塞州波士顿的马萨诸塞州综合医院癌症中心、北卡罗来纳州达勒姆的杜克癌症中心和宾夕法尼亚州费城的宾夕法尼亚大学艾布拉姆森癌症中心。目标样本量为510名患者。这项研究由国家癌症研究所资助，由达纳-法伯/哈佛癌症中心机构审查委员会批准，并将根据报告试验声明的综合标准进行报告。我们将通过专业协会会议、同行评议出版物和向患者组织发布报告来传播结果。NCT03337399。
Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients’ needs. We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients’ quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are ‘stepped up’ and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients. The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations. NCT03337399.
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影响因子：
45.3
作者：
Ferrell, Betty R.;Temel, Jennifer S.;Smith, Thomas J.
通讯作者：
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