Brief Behavioral Intervention for Dyspnea in Patients with Advanced Lung Cancer

项目摘要 背景：呼吸困难是晚期肺癌常见的衰弱症状，大约有 50%的患者出现明显的气喘吁吁。呼吸困难与生活质量受损有关， 参加社会活动减少，出现抑郁和焦虑症状，甚至想死 肺癌患者。不幸的是，有限的数据支持对呼吸困难的有效治疗。我们的 多学科团队最近进行了一项试点研究，考察了一项简短的、两节课的行为 晚期肺癌患者呼吸困难处理的干预。训练有素的执业护士 对输液诊所的患者进行干预，以促进更多的接触和参与。我们 在统计学和临床上观察到对患者报告的呼吸困难、生活质量和 抑郁症状，以及患者对干预组件和交付的高满意度。 研究目标：对于拟议的项目，我们寻求在先前积极发现的基础上，通过进行 对晚期肺癌患者进行大样本干预的随机对照试验(RCT)。 我们将首先培训肿瘤科护士，再次为呼吸困难的管理提供简短的行为干预 在输液诊所内的护理点，因为这种方法是可行性和可接受性的核心 对我们先导研究的干预。这项研究的具体目的是为了证明简明 行为干预以改善自我报告的呼吸困难(主要结果)以及生活质量，情绪， 晚期肺癌患者的活动水平(二次结局)。研究设计与方法：我们 将登记并随机分配最多200名被诊断为晚期肺癌的患者(每个研究组100名) 接受针对呼吸困难的短暂行为干预或常规护理。审判将在 马萨诸塞州总医院癌症中心和达纳-法伯癌症研究所。肿瘤科护士会 在输液诊所内为每位参与者提供两次45分钟的干预会议。所有参与者将 呼吸困难、生活质量、焦虑和抑郁症状以及活动水平的完整测量 干预阶段结束后8周、16周和24周的基线。结论：非阿片类药物 药物的临床益处很小，缺乏数据来支持治疗呼吸困难的疗效， 一种严重损害晚期肺癌患者的症状。我们计划培训肿瘤科护士 提供结合了被证明有效的行为技术的呼吸困难管理干预 用于改善癌症患者的呼吸困难和减轻压力。通过培训医学临床医生来 在肿瘤护理环境中进行行为干预，我们希望最大限度地广泛传播 以及患者获得基本症状管理的机会。此R01中的数据最终将作为 申请资金用于大规模、多地点干预的有效性和传播研究。

Project Summary Background: Dyspnea is a common and debilitating symptom of advanced lung cancer, with approximately 50% of patients reporting marked breathlessness. Dyspnea is associated with impaired quality of life, decreased participation in social activities, symptoms of depression and anxiety, and even desire for death in patients with lung cancer. Unfortunately, limited data support efficacious treatments for dyspnea. Our multidisciplinary team recently conducted a pilot study examining the delivery of a brief, two-session behavioral intervention for dyspnea management in patients with advanced lung cancer. Trained nurse practitioners administered the intervention to patients in the infusion clinic to facilitate greater access and participation. We observed statistically and clinically significant effects on patient-reported breathlessness, quality of life, and depression symptoms, as well as high patient satisfaction with the intervention components and delivery. Study Aims: For the proposed project, we seek to build on our prior positive findings by conducting a randomized controlled trial (RCT) of the intervention in a larger sample of patients with advanced lung cancers. We will first train oncology nurses to deliver the brief behavioral intervention for dyspnea management, again at the point of care within the infusion clinic as this approach was central to the feasibility and acceptability of the intervention in our pilot study. The specific aims of this study are to demonstrate the efficacy of the brief behavioral intervention for improving self-reported dyspnea (primary outcome) as well as quality of life, mood, and activity level (secondary outcomes) in patients with advanced lung cancer. Study Design & Methods: We will enroll and randomly assign up to 200 patients diagnosed with advanced lung cancer (100 per study group) to receive either the brief behavioral intervention for dyspnea or usual care. The trial will take place at the Massachusetts General Hospital Cancer Center and the Dana-Farber Cancer Institute. Oncology nurses will deliver two, 45 minute interventions sessions for each participant within the infusion clinic. All participants will complete measures of dyspnea, quality of life, anxiety and depression symptoms, as well as activity level at baseline after completion of the intervention phase at 8, 16, and 24 weeks. Conclusions: Other than opioid medications, which offer little clinical benefit, data are lacking to support the efficacy of treatments for dyspnea, a highly impairing symptom in patients with advanced lung cancer. We plan to train oncology nurses in delivering a dyspnea management intervention that incorporates behavioral techniques shown to be effective for improving breathlessness and reducing stress in patients with cancer. By training medical clinicians to administer the behavioral intervention in the oncology care setting, we hope to maximize broad dissemination and patient access to essential symptom management. Data from this R01 will ultimately serve as the basis to apply for funding for a large-scale, multisite effectiveness and dissemination study of the intervention.