A RCT to determine the effectiveness of a stress reduction intervention in caregivers of allogeneic hematopoietic stem cell transplant (HSCT) recipients.

数百万美国人为年老或生病的家庭成员和朋友提供无偿护理。对正在接受干细胞移植的癌症患者的护理特别有压力。工作压力与许多疾病有关，包括睡眠障碍、抑郁和焦虑。虽然有很好的证据表明，癌症照顾者经历高水平的压力和压力相关的症状，很少有干预研究已经探讨，以解决这一问题，在这一人群。 减压技巧是个人科普癌症治疗压力的重要技能。瑜伽和冥想等正念技巧可以降低照顾者的压力和与压力相关的症状。 然而，许多护理人员不愿意从患者身上抽出时间来照顾自己的健康和福祉。很少有研究探索可以在家里或病人床边进行的基于瑜伽的减压干预。 本研究将采用前瞻性随机对照组设计，研究为期6周的瑜伽减压干预对同种异体HSCT患者照顾者感知压力的影响。如果受试者是在NIH临床中心接受同种异体HSCT的个体的护理者，年龄> 18岁，能够阅读英语，独立站立和坐立，将手臂举过头顶而没有疼痛，并且能够理解研究的研究性质，则受试者将被纳入本方案。至少需要78名护理人员的样本才能充分评估干预措施的有效性。 所有护理人员将参加临床中心为移植护理人员提供的常规护理小组教育。随机分配到干预组的护理人员将被安排与研究人员进行一次会议，以接收20分钟的温和椅子瑜伽姿势和指导呼吸意识的音频文件，以及执行这些动作的说明，并要求他们每天练习。将在基线（HSCT时或接近HSCT时）和6周干预结束时收集所有研究参与者的数据（以基于网络的问卷调查的形式）以及身体评估、人口统计学访谈和血液检查。干预期后将不会进行长期随访。这些文件包括：照顾者反应评估，健康促进生活方式概况II，匹兹堡睡眠质量指数，弗赖堡正念量表，焦虑、应用认知、抑郁、疲劳、积极情感和幸福感的PROMIS测量，以及孤独、自我效能和感知压力的NIH ESTA测量。受试者将在研究结束时参加退出访谈，干预人员将根据受试者日记填写日志，跟踪受试者实践以及计划和实际会话日期和时间之间的差异。本研究将采用定量分析技术。 该研究于2014年9月24日获得IRB批准，招募开始，第1例受试者于2015年1月入组。截至2015年9月，已入组13例受试者，其中n=8例完成所有研究程序，2例受试者退出研究。

Millions of Americans provide unpaid care for aging or ill family members and friends. Caregiving for an individual with cancer who is undergoing stem cell transplantation is particularly stressful. The stress of caregiving is associated with many disorders, including sleep disturbances, depression, and anxiety. Although there is good evidence that cancer caregivers experience high levels of stress and stress-related symptoms, few interventions studies have been explored to address this concern in this population. Stress reduction techniques are important skills for individuals to cope with the stress of cancer caregiving. Mindfulness techniques such as yoga and meditation reduce levels of stress and stress-related symptoms in caregivers. However, many caregivers are reluctant to take time away from the patient to attend to their own health and well-being. Few studies have explored yoga-based stress reduction interventions that can be performed at home or at the patients bedside. This study will use a prospective randomized control group design to examine the effects of a six-week yoga-based stress reduction intervention on perceived stress in caregivers of allogeneic HSCT patients. Subjects will be accrued to this protocol if they are a caregiver of an individual undergoing allogeneic HSCT at the Clinical Center, NIH, are > 18 years old, able to read English, stand and sit unassisted, raise arms over head without pain, and able to comprehend the investigational nature of the study. A sample of at least 78 caregivers is needed to adequately evaluate the effectiveness of the intervention. All caregivers will attend the usual care group education provided at the Clinical Center for transplant caregivers. Caregivers randomized to the intervention group will be scheduled for one session with study personnel to receive a 20 minute audio file of gentle chair yoga poses and guided breath awareness, as well as instructions for performing them, and they will be asked to practice daily. Data, in the form of web-based questionnaires, as well as a physical assessment, demographic interview and blood work will be collected from all study participants at baseline (at or near the time of HSCT) and again at the end of the six-week intervention. There will be no long-term follow-up after the intervention period. Questionnaires include: Caregiver Reaction Assessment, Health-Promoting Lifestyle Profile II, Pittsburgh Sleep Quality Index, Freiburg Mindfulness Scale, PROMIS measures of anxiety, applied cognition, depression, fatigue, positive affect and well-being, and NIH Toolbox measures of loneliness, self-efficacy, and perceived stress. Subjects will participate in an exit interview at the end of the study and the interventionist will complete a log, based on subject diaries, that tracks subject practice, and discrepancy between planned and actual session date and time. Quantitative analysis techniques will be used in this study. The study was approved by the IRB on September 24, 2014, recruitment began and the 1st subject was enrolled in January 2015. As of September 2015, 13 subjects have been enrolled, with n=8 completing all study procedures and two subjects were removed from study participation.