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支持性肿瘤学居家护理干预措施:临床试验方案以转变癌症患者的护理模式。

Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer.

机构信息

Massachusetts General Hospital, 55 Fruit Street, Yawkey 9E, Boston, MA, 02114, USA.

Harvard Medical School, Boston, MA, USA.

出版信息

BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z.

Abstract

BACKGROUND

Patients with cancer often endure substantial symptoms and treatment toxicities leading to high healthcare utilization, including hospitalizations and emergency department visits, throughout the continuum of their illness. Innovative oncology care models are needed to improve patient outcomes and reduce their healthcare utilization. Using a novel hospital at home care platform, we developed a Supportive Oncology Care at Home intervention to address the needs of patients with cancer.

METHODS

We are conducting three trials to delineate the role of Supportive Oncology Care at Home for patients with cancer. The Supportive Oncology Care at Home intervention includes: (1) a hospital at home care model for symptom assessment and management; (2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and (3) structured communication with the oncology team. Our first study is a randomized controlled trial to test the efficacy of Supportive Oncology Care at Home versus standard oncology care for improving healthcare utilization, cancer treatment interruptions, and patient-reported outcomes in patients with cancer receiving definitive treatment of their cancer. Participants include adult patients with gastrointestinal and head and neck cancer, as well as lymphoma, receiving definitive treatment (e.g., treatment with curative intent). The second study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention for hospitalized patients with advanced cancer. Eligible participants include adult patients with incurable cancer who are admitted with an unplanned hospitalization. The third study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention to enhance the end-of-life care for patients with advanced hematologic malignancies. Eligible participants include adult patients with relapsed or refractory hematologic malignancy receiving palliative therapy or supportive care alone.

DISCUSSION

These studies are approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and are being conducted in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. This work has the potential to transform the paradigm of care for patients with cancer by providing them with the necessary support at home to improve their health outcomes and care delivery.

TRIAL REGISTRATIONS

NCT04544046, NCT04637035, NCT04690205.

摘要

背景

癌症患者在疾病持续过程中经常会经历大量的症状和治疗毒性,导致高医疗保健利用率,包括住院和急诊就诊。需要创新的肿瘤学护理模式来改善患者的预后并降低他们的医疗保健利用率。我们使用一种新颖的家庭医院护理平台,开发了一种支持性肿瘤学家庭护理干预措施,以满足癌症患者的需求。

方法

我们正在进行三项试验,以确定支持性肿瘤学家庭护理对癌症患者的作用。支持性肿瘤学家庭护理干预措施包括:(1)用于症状评估和管理的家庭医院护理模式;(2)对日常患者报告的症状、生命体征和体重进行远程监测;(3)与肿瘤团队进行结构化沟通。我们的第一项研究是一项随机对照试验,旨在测试支持性肿瘤学家庭护理与标准肿瘤学护理相比,在改善癌症治疗中断和患者报告的接受癌症确定性治疗的癌症患者的医疗保健利用率和结局方面的疗效。参与者包括接受确定性治疗(例如,有治愈意图的治疗)的胃肠道和头颈部癌症以及淋巴瘤的成年患者。第二项研究是一项单臂试验,评估支持性肿瘤学家庭护理干预措施对住院晚期癌症患者的可行性和可接受性。符合条件的参与者包括因计划外住院而入院的不可治愈癌症的成年患者。第三项研究是一项单臂试验,评估支持性肿瘤学家庭护理干预措施增强晚期血液恶性肿瘤患者临终关怀的可行性和可接受性。符合条件的参与者包括接受姑息治疗或单独支持性护理的复发性或难治性血液恶性肿瘤的成年患者。

讨论

这些研究已获得达纳-法伯/哈佛癌症中心机构审查委员会的批准,并按照非药物试验的《合并报告标准声明》进行。这项工作有可能通过为癌症患者在家中提供必要的支持来改善他们的健康结局和护理提供,从而改变癌症患者的护理模式。

试验注册

NCT04544046、NCT04637035、NCT04690205。

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