A Pilot Study of Yoga for Breathing and Quality of Life of Lung Cancer Patients

描述（由申请人提供）：肺癌是全球癌症死亡的主要原因，在美国影响了近40万人，对身心健康造成毁灭性影响，损害了整体生活质量（QOL）。尽管非小细胞肺癌（NSCLC）患者的5年生存率缓慢上升，但由于诊断阶段、癌症治疗和并发合病而造成的过度症状负担仍然非常普遍。由于呼吸系统受损，压力增加，睡眠和情绪受损，恐惧和焦虑会进一步加剧。因此，迫切需要以循证为基础的辅助疗法，如瑜伽来治疗症状。这项两组随机对照研究旨在(1)与健康教育组比较，确定标准化的12周瑜伽干预对I-IIIa期NSCLC患者呼吸的影响，特别是肺量测量值、呼吸频率、报告的呼吸困难强度和不适、氧合和呼吸意识；(2)与轻度运动（LE）组相比，评估标准化的12周瑜伽干预对I-IIIa期非小细胞肺癌患者报告的压力、情绪、睡眠和生活质量的影响。两家国家癌症研究所综合癌症中心（肺部诊所）将招募接受手术干预的I-IIIa期非小细胞肺癌患者（N=60）。有骨转移、认知障碍、严重呼吸问题和/或接受放射治疗的患者将被排除在外。在两年的时间里，预计每月将有3-4名患者入组。参与者将被随机分配到干预组或对照组，定义为12周的40分钟瑜伽课（YG）或每周一次的LE课程。LE课程将包括使用阻力带，拉伸和温和步行的轻度运动；会议将由训练有素的研究助理提供。瑜伽课程将由训练有素的瑜伽老师提供，他们已经被导向我们的标准化瑜伽协议（在之前的试点研究中测试过）。YG和LE参与者将收到插图手册，指导家庭练习；在12周的随访期结束时，将发放一张CD和/或DVD。结局变量和相关测量包括：呼吸（肺活量测定、脉搏血氧测定、呼吸困难、呼吸率、6分钟步行试验）；氧合（脉搏血氧仪；心率）；压力（感知压力量表；每日唾液皮质醇）；情绪（情绪状态简介）；睡眠（匹兹堡睡眠质量指数；活动记录仪）；和QOL（肺癌治疗功能评估）。参与者还将完成瑜伽和LE家庭练习的自我报告日志，以及呼吸意识日志。测量将在基线、3周、6周、9周和/或12周间隔（取决于测量）以及干预后3个随访时间点（1个月、3个月和6个月）获得。

DESCRIPTION (provided by applicant): Lung cancer, the leading cause of cancer mortality worldwide, affects almost 400,000 individuals in the United States,and has devastating effects on physical and psychological health which compromise overall quality of life (QOL). Although the 5-year survival rate has slowly increased for non-small cell lung cancer (NSCLC) patients, excessive symptom burden due to stage at diagnosis, cancer treatment, and concurrent co-morbidity remain extremely prevalent. Fear and anxiety is further intensified due to respiratory compromise, increasing stress, and impairing sleep and mood. Hence, there is a critical need for evidenced-based adjunctive therapies such as yoga for symptom management. This two-group randomized controlled study aims to (1) Identify the effects of a standardized, 12-week yoga intervention on breathing, specifically spirometry values, respiratory rate, reported dyspnea intensity and discomfort, oxygenation, and breathing awareness of Stage I-IIIa NSCLC patients as compared with a health education group; and (2) Evaluate the effects of a standardized, 12-week yoga intervention on reported stress, mood, sleep and quality of life of Stage I-IIIa NSCLC patients as compared with a light exercise (LE) group. A sample of Stage I-IIIa NSCLC patients (N=60) who have undergone surgical intervention will be recruited at two National Cancer Institute Comprehensive Cancer Centers (lung clinics). Patients with bone metastasis, cognitive impairment, severe respiratory problems and/or receiving radiation will be excluded. An estimated 3-4 patients per month will be enrolled over a two-year period. Participants will be randomized to the intervention or control condition, defined as 12-weeks of a 40 minute yoga class (YG), or LE session once per week, respectively. The LE sessions will include light exercises using resistance bands, stretching and gentle walking; the session will be provided by a trained research assistant. Yoga classes will be provided by trained yoga teachers who have been oriented to our standardized yoga protocol (tested in previous pilot study). YG and LE participants will receive illustrated manuals to guide home practice; a CD and/or DVD will be given at the end of 12-weeks for the follow-up period. Outcome variables and related measures include: Breathing (spirometry, pulse oximetry, dyspnea, respiration rate, 6-Minute Walk test); oxygenation (pulse oximetry; heart rate); stress (Perceived Stress Scale; diurnal salivary cortisol); mood (Profile of Mood States-Brief); sleep (Pittsburgh Sleep Quality Index; Actigraphy); and QOL (Functional Assessment of Cancer Treatment-Lung). Participants will also complete self report logs on yoga and LE home practice, and a breathing awareness journal. Measures will be obtained at Baseline, and at three, six, nine and/or twelve-week intervals (depending on the measure), and at three follow- up time points (one, three and six months) post intervention.