Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America; Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States of America; Center for Primary Care and Outcomes Research/Health Research and Policy, Stanford University School of Medicine, Stanford, CA, United States of America.
Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States of America.
Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4.
Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations.
The "Lay health worker Educates Engages and Activates Patients to Share (LEAPS)" intervention was developed to improve advance care planning and symptom management among low-income and minority hourly-wage workers with cancer, in two community settings. The intervention provides a lay health worker to all patients newly diagnosed with cancer and aims to educate and activate patients to engage in advance care planning and symptom management with their oncology providers. In this randomized clinical trial, we will evaluate the effect on quality of life (primary outcome) using the validated Functional Assessment of Cancer Therapy - General Survey, at enrollment, 4- and 12- months post-enrollment. We will examine between-group differences on our secondary outcomes of patient activation, patient satisfaction with healthcare decision-making, and symptom burden (at enrollment, 4- and 12-months post-enrollment), and total healthcare use and healthcare costs (at 12-months post-enrollment).
Multilevel approaches are urgently needed to improve cancer care delivery among low-income and minority patients diagnosed with cancer in community settings. The current study describes the LEAPS intervention, the study design, and baseline characteristics of the community centers participating in the study. ClinicalTrials.gov Registration #NCT03699748.
在癌症护理中，公平地提供预先护理计划和症状管理对于改善癌症护理至关重要。现有的提高这些服务利用率的干预措施主要发生在诊所环境中，其效果有限，特别是在低收入和少数族裔人群中。
“非专业卫生工作者教育、鼓励并使患者参与分享（LEAPS）”干预措施是为了提高低收入和少数小时工癌症患者的预先护理计划和症状管理水平而在两个社区环境中开发的。该干预措施为所有新诊断出癌症的患者提供一名非专业卫生工作者，旨在教育和激励患者与肿瘤学提供者一起参与预先护理计划和症状管理。在这项随机临床试验中，我们将使用经过验证的癌症治疗功能评估 - 一般调查（Functional Assessment of Cancer Therapy - General Survey）评估生活质量（主要结果），在入组时、入组后 4 个月和 12 个月进行评估。我们将研究患者激活、患者对医疗决策的满意度和症状负担（入组时、入组后 4 个月和 12 个月）以及总医疗使用和医疗费用（入组后 12 个月）等次要结果的组间差异。
迫切需要多层次的方法来改善社区环境中低收入和少数族裔癌症患者的癌症护理提供。本研究描述了 LEAPS 干预措施、研究设计以及参与研究的社区中心的基线特征。ClinicalTrials.gov 注册号：NCT03699748。
