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

描述(申请人提供)：肺癌是全球癌症死亡的主要原因，影响着美国近40万人，并对身心健康造成破坏性影响，损害整体生活质量(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、癌症治疗阶段的过度症状负担以及并发的共病仍然非常普遍。由于呼吸受损，压力增加，睡眠和情绪受损，恐惧和焦虑进一步加剧。因此，迫切需要以证据为基础的辅助疗法，如瑜伽，用于症状管理。这项两组随机对照研究(N=60)的目的是：(1)与健康教育组相比，标准化12周瑜伽干预对I-IIIa期非小细胞肺癌患者呼吸的影响，特别是肺活量、呼吸频率、报告的呼吸困难强度和不适、氧合和呼吸意识；(2)与健康教育组相比，评估标准化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。接受手术治疗的I-IIIa期非小细胞肺癌患者(N=60)的样本将在两个国家癌症研究所综合癌症中心(肺部诊所)招募。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。估计每月将有3-4名患者参加，为期两年。参与者将随机进入干预或对照条件，定义为每周一次的为期12周的45分钟瑜伽课(YG)或健康教育(Health Ed)课程。健康教育组的内容已经划定，包括营养与癌症、维生素、治疗期间的补充剂和草药、生存和照顾者问题等主题，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教师提供，他们已经适应了我们的标准化瑜伽方案(在之前的试点研究中进行了测试)；YG参与者将收到指导家庭练习的瑜伽手册。结果变量和相关测量包括：呼吸(肺功能、脉搏血氧饱和度、呼吸困难、呼吸频率、6分钟步行试验)；氧合(脉搏血氧饱和度；心率)；压力(感知压力量表；白天唾液皮质醇)；情绪(情绪状态简介-简要)；睡眠(匹兹堡睡眠质量指数；活动描记)；QOL(癌症治疗的功能评估-肺)。参与者还将完成关于瑜伽家庭练习(干预组)和呼吸意识(干预和控制)的自我报告日志。将在干预后的基线、三周、六周、九周和/或十二周(取决于衡量标准)以及三个后续时间点(一个月、三个月和六个月)获得措施。

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 (N=60) aims to (1) Identify the effects of a standardized12-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 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 health education 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. 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 45 minute yoga class (YG), or Health education (Health Ed) session once per week, respectively. Content for the Health Ed group has been delineated and includes topics such as nutrition and cancer, vitamins, supplements and herbs during treatment, survivorship and caregiver issues etc. which 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 participants will receive Yoga Manuals to guide home practice. 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); QOL (Functional Assessment of Cancer Treatment-Lung). Participants will also complete self report logs on yoga home practice (Intervention group), and breathing awareness (Intervention and control). 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.