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Brief Behavioral Intervention for Dyspnea in Patients with Advanced Lung Cancer

晚期肺癌患者呼吸困难的简短行为干预

基本信息

批准号：
9216504
负责人：
Joseph Andrew Greer
金额：
$ 53.32万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-19 至 2021-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9216504
关键词：
Accident and Emergency department Advanced Malignant Neoplasm Age American Applications Grants Behavior Therapy Behavioral Breathing Cancer Burden Cancer Center Caring Cessation of life Client satisfaction Clinic Clinical Comorbidity Comprehensive Cancer Center Dana-Farber Cancer Institute Data Diagnosis Disease Dyspnea Dyspnea Management Effectiveness Enrollment Etiology Funding Gender General Hospitals Home environment Hospitalization Impairment Infusion procedures Interdisciplinary Study Intervention Intervention Studies Intervention Trial Investigation Lung Malignant Neoplasms Malignant neoplasm of lung Massachusetts Measures Mediating Mediator of activation protein Medical Methods Moods Nurse Practitioners Nurses Oncologic Nursing Oncologist Oncology Nurse Opioid Outcome Outpatients Oxygen Palliative Care Participant Patient Outcomes Assessments Patient Self-Report Patients Performance Status Pharmaceutical Preparations Phase Pilot Projects Pleural effusion disorder Protocols documentation Psychiatrist Psychological Factors Psychologist Quality of life Randomized Randomized Controlled Trials Reporting Research Research Design Sampling Societies Stress Supportive care Symptoms Target Populations Techniques Testing Training Treatment Efficacy Visit Widespread Disease Withdrawal Work anxiety symptoms cancer care clinically significant common symptom depressive symptoms disabling symptom efficacy testing end of life evidence base experience health care service utilization improved intervention effect mood symptom multidisciplinary nursing intervention oncology point of care primary outcome psychological symptom psychosocial secondary outcome social symptom management treatment as usual

项目摘要

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.

项目概要背景：呼吸困难是晚期肺癌的常见且使人衰弱的症状，大约有 50% 的患者报告有明显的呼吸困难。呼吸困难与生活质量受损有关，社会活动参与度下降，出现抑郁、焦虑症状，甚至产生求死欲肺癌患者。不幸的是，有限的数据支持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，检查了简短的两次行为行为的交付晚期肺癌患者呼吸困难管理的干预措施。训练有素的执业护士对输液诊所的患者进行干预，以促进更多的访问和参与。我们观察到对患者报告的呼吸困难、生活质量和生活质量的统计和临床显着影响抑郁症状，以及患者对干预措施和实施的高度满意度。研究目的：对于拟议的项目，我们力求通过开展一项研究，以我们之前的积极发现为基础对更大样本的晚期肺癌患者进行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，因为这种方法对于输液诊所的可行性和可接受性至关重要我们的试点研究中的干预。本研究的具体目的是证明简短的有效性行为干预，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（次要结果）。研究设计和方法：我们将招募并随机分配最多 200 名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简短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丹纳法伯癌症研究所。肿瘤科护士将在输液诊所内为每位参与者提供两次 45 分钟的干预课程。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 8、16 和 24 周干预阶段完成后的基线。结论：除阿片类药物外药物治疗几乎没有临床益处，缺乏支持呼吸困难治疗效果的数据，对晚期肺癌患者来说是一种严重损害的症状。我们计划培训肿瘤科护士提供呼吸困难管理干预措施，其中结合了行之有效的行为技术用于改善癌症患者的呼吸困难并减轻压力。通过培训临床医生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。 R01 的数据最终将作为申请资助以进行大规模、多地点的干预措施有效性和传播研究。