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

瑜伽对肺癌患者呼吸和生活质量的初步研究

• 批准号: 8497000
• 负责人: Judith Marie Fouladbakhsh
• 金额: $ 21.29万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2014-10-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8497000
• 关键词: Address; Affect; African American; American; Anxiety; Awareness; Breast; Breathing; Breathing Exercises; Cancer Center; Cancer Etiology; Cancer Patient; Cancer Survivor; Clinic; Clinical; Clinical Trials; Comorbidity; Complementary and alternative medicine; Comprehensive Cancer Center; Data; Dose; Dyspnea; Enrollment; Evidence based treatment; Female; Fright; Gender; Geographic Locations; Goals; Health Benefit; Health education; Heart Rate; Home environment; Hydrocortisone; Impaired cognition; Individual; Intervention; Journals; Life; Light; Light Exercise; Literature; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Manuals; Measures; Meditation; Mental Health; Metastatic Neoplasm to the Bone; Moods; Movement; National Cancer Institute; Non-Small-Cell Lung Carcinoma; Operative Surgical Procedures; Outcome; Participant; Patient Self-Report; Patients; Personal Satisfaction; Physiological; Pilot Projects; Population; Population Heterogeneity; Posture; Prevalence; Protocols documentation; Public Health; Pulmonary Function Test/Forced Expiratory Volume 1; Pulse Oximetry; Quality of life; Race; Radiation; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Research Training; Resistance; Respiration; Rest; Salivary; Sampling; Self Care; Sleep; Spirometry; Stage I Sleep; Stage at Diagnosis; Staging; Stress; Stretching; Survival Rate; Symptoms; Testing; Therapeutic; Time; Training; Underserved Population; United States; Use Effectiveness; Vital capacity; Walking; Woman; Work; Yoga; actigraphy; arm; cancer diagnosis; cancer therapy; cost; evidence base; follow-up; improved; indexing; interest; male; mortality; patient population; physical conditioning; post intervention; programs; psychologic; public health relevance; respiratory; response; symptom management; teacher; treatment planning

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.

描述（由申请人提供）：肺癌是全球癌症死亡率的主要原因，在美国影响近40万人，对身体和心理健康具有破坏性影响，影响整体生活质量（QOL）。尽管非小细胞肺癌（NSCLC）患者的5年生存率缓慢增加，但由于诊断阶段、癌症治疗和并发共病导致的过度症状负担仍然非常普遍。恐惧和焦虑由于呼吸系统受损、压力增加、睡眠和情绪受损而进一步加剧。因此，迫切需要基于证据的预防性治疗，如瑜伽用于症状管理。这项两组随机对照研究的目的是（1）确定与健康教育组相比，标准化的12周瑜伽干预对I-IIIa期NSCLC患者呼吸的影响，特别是肺量测定值、呼吸频率、报告的呼吸困难强度和不适、氧合和呼吸意识;和（2）评估与轻度运动（LE）组相比，标准化的12周瑜伽干预对I-IIIa期NSCLC患者报告的压力、情绪、睡眠和生活质量的影响。将在两个国家癌症研究所综合癌症中心（肺部诊所）招募接受手术干预的I-IIIa期NSCLC患者样本（N=60）。将排除骨转移、认知障碍、严重呼吸问题和/或接受放疗的患者。在2年期间，估计每月将入组3-4例患者。参与者将被随机分配到干预或对照条件，定义为12周的40分钟瑜伽课程（YG）或LE课程，每周一次。LE课程将包括使用阻力带的轻度运动，拉伸和轻柔行走;课程将由训练有素的研究助理提供。瑜伽课程将由受过培训的瑜伽教师提供，他们已经被导向我们的标准化瑜伽协议（在以前的试点研究中测试）。YG和LE参与者将获得指导家庭实践的插图手册;在12周结束时将提供CD和/或DVD用于随访期。结果变量和相关指标包括：呼吸（肺量测定法、脉搏血氧测定法、呼吸困难、呼吸率、6分钟步行试验）;氧合（脉搏血氧测定法;心率）;压力（感知压力量表;昼夜唾液皮质醇）;情绪（情绪状态简介-简报）;睡眠（匹兹堡睡眠质量指数;活动记录）;和QOL（癌症治疗功能评估-肺）。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。将在基线、干预后3周、6周、9周和/或12周间隔（取决于测量）以及3个随访时间点（1个月、3个月和6个月）获得测量值。