Reducing Lung Cancer Survivor Anxiety (RELAX) with Brief Device-Guided Breathing

项目摘要 肺癌是美国第二常见的癌症，但很少有“生存”研究。 专注于这个人群。随着早期肺癌（ESLC）幸存者人数的增加， 在低剂量计算机断层扫描肺癌筛查中， 制定干预措施，改善他们的福祉。20%到30%的人报告有临床意义的焦虑 肺癌患者和治疗后幸存者。此外，焦虑经常与呼吸困难同时发生 （呼吸急促），这可能会加剧潜在的焦虑。RESPeRATE是FDA批准的 生物反馈装置，监测呼吸模式并温和地引导用户降低呼吸率 增加他们的呼气时间研究的目的是确定这种设备引导呼吸的可行性 干预与音乐对照组，并获得对焦虑，呼吸困难， 肺功能和功能适应性。本研究将入组60例治疗后ESLC 通过维克森林社区临床的两个站点， 肿瘤学项目研究基地（WF CCOP RB）：维克森林综合癌症中心 大学和威奇托CCOP网站）。该初步试验将分为三组：低剂量（15分钟，每次一次） 日）RESPeRATE器械引导呼吸（n=20），高剂量（15分钟，每日两次）RESPeRATE （n=20），音乐对照组（15分钟，每日1次）（n=20）。随机化后，每名受试者将接受 设备和适当的说明（RESPeRATE或MP3播放器加家用心率监测器），并将 在家使用该设备8周。自我报告的结局（焦虑、呼吸困难）、肺功能检查， 并在基线和第8周完成功能体能评估（6分钟步行）。目标1将 评估随机对照研究的可行性（招募、参与、保留、依从性）， 在60例有临床意义焦虑的治疗后ESLC患者中进行设备引导的音乐呼吸 症状目的2将获得关于两种剂量的 与音乐对照组相比，RESPeRATE干预改善焦虑（主要结局）， 治疗后ESLC患者的呼吸困难、肺功能和功能健康（次要结局）。 目的3是选择设备引导的呼吸干预的最佳剂量，用于随后的完全- 有把握的随机对照试验这项研究的结果将为我们提供出色的初步数据， 一项大型随机对照试验的计划R 01申请，该试验将通过WF CCOP RB进行， 可以更好地阐明所提出的简单干预对焦虑的治疗后ESLC幸存者的影响， 可以很容易地传播。

PROJECT SUMMARY Lung cancer is the second-most common cancer diagnosed in the US, yet little "survivorship" research has focused on this population. As the number of early stage lung cancer (ESLC) survivors increases because of uptake in low dose computerized tomography lung cancer screening, it will be increasingly important to develop interventions to improve their well-being. Clinically significant anxiety is reported by 20% to 30% of lung cancer patients and post-treatment survivors. Further, anxiety frequently co-occurs with dyspnea (shortness of breath), which can exacerbate the underlying anxiety. RESPeRATE is an FDA-approved biofeedback device that monitors respiration patterns and gently guides users to reduce their respiration rate and increase their exhalation time. The goal of study is to determine feasibility of this device-guided breathing intervention versus a music control group and to obtain preliminary data on effects on anxiety, dyspnea, pulmonary function, and functional fitness in ESLC survivors. This study will enroll 60 post-treatment ESLC survivors with clinically meaningful anxiety symptoms through two sites of the Wake Forest Community Clinical Oncology Program Research Base (WF CCOP RB): the Comprehensive Cancer Center of Wake Forest University and the Wichita CCOP site). This pilot trial will have three groups: low-dose (15 minutes, once per day) RESPeRATE device-guided breathing (n=20), high-dose (15 minutes, twice per day) RESPeRATE (n=20), and music control (15 minutes, once per day) (n=20). After randomization, each participant will receive a device and appropriate instruction (RESPeRATE or an MP3 player plus home heart rate monitor) and will use the device at home for 8 weeks. Self-reported outcomes (anxiety, dyspnea), pulmonary function testing, and functional fitness assessment (6-minute walk) will be completed at baseline and 8 weeks. Aim 1 will assess the feasibility (accrual, participation, retention, adherence) of a randomized controlled study comparing device-guided breathing to music in 60 post-treatment ESLC patients with clinically meaningful anxiety symptoms. Aim 2 will obtain preliminary data regarding the variability and efficacy of two doses of the RESPeRATE intervention compared to a music control group for improving anxiety (primary outcome) and dyspnea, pulmonary function, and functional fitness (secondary outcomes) in post-treatment ESLC patients. Aim 3 is to select the optimal dose of the device-guided breathing intervention for use in a subsequent, fully- powered randomized control trial. The results of this study will provide outstanding preliminary data for our planned R01 application for a larger randomized controlled trial that will be run through the WF CCOP RB that can better elucidate the impact of the proposed simple intervention for anxious, post-treatment ESLC survivors, that can be easily disseminated.