Breathe-Intervention for Hot Flashes, Interference, and Associated Outcomes

描述（由申请人提供）：对于数以百万计的乳腺癌幸存者和没有乳腺癌的绝经期妇女来说，潮热是频繁、严重和令人烦恼的事件，可以干扰日常生活，对情绪、影响和/或睡眠产生负面影响。不幸的是，管理潮热的科学依据是有限的。美国国立卫生研究院最近的一次科学状况会议得出的主要结论是，需要更多的数据来证明非激素治疗潮热的有效性和适宜性。尽管北美更年期协会推荐缓慢深呼吸作为潮热的一线治疗方法，但这些建议是基于之前的两项研究，这些研究包括少数没有乳腺癌的更年期妇女，使用了复杂的时间和资源密集型教学方案，并纳入了范围狭窄的结果。这些限制限制了目前疗效的证据，并降低了这种有前途的非激素潮热治疗被广泛应用的可能性。在乳腺癌幸存者和无乳腺癌的绝经期妇女中，该随机对照试验评估了基于dvd的简化的家庭慢呼吸训练和练习方案，与基于dvd的快速浅呼吸训练的注意力控制条件和无治疗的常规护理控制条件。目的是评估(1)对生理性和主观性潮热的疗效（客观频率和主观频率，严重程度，困扰，持续时间），(2)对感知到的潮热干扰和相关结果（情绪，情感，睡眠）的疗效，(3)乳腺癌幸存者和未患癌症的绝经妇女之间疗效的差异，以及(4)在临床实践中传播研究结果的可接受性和可用性(治疗可接受性，结果预期，治疗的可信度，以及实践和应用的频率)。本研究还将检查基线特征作为潜在的疗效协变量，包括客观潮热频率、体重指数、种族、民族、教育程度、先前呼吸训练、吸烟状况、绝经状态、使用选择性雌激素受体调节剂或芳香化酶抑制剂、使用其他潮热治疗和合并症。195名符合纳入标准的乳腺癌幸存者和195名无癌症的绝经期妇女将被分层并随机分为缓慢深呼吸组、快速浅呼吸的注意控制组或无治疗的常规护理对照组。结果将由随机分组的研究助理在基线和干预后8周和16周进行评估。为了评估慢深呼吸组的治疗完整性，将在每个数据收集点使用便携式呼吸传感器来评估正常呼吸和慢深呼吸期间的呼吸深度和频率。研究结果将为支持或反对使用缓慢深呼吸缓解生理性和/或主观性潮热、感知到的潮热干扰和相关结果提供经验证据。重要的是，阳性或阴性结果将为临床医生的建议和消费者的治疗选择提供指导，无论是赞成还是反对使用缓慢的深呼吸。如果研究结果支持有效性、可接受性和可用性，我们基于dvd的干预措施可以很容易地广泛传播，以替代或补充现有的药物或非药物热闪治疗。公共卫生相关段落：本研究的结果将为支持或反对使用缓慢深呼吸来缓解生理性和/或主观性潮热、感知到的潮热干扰和相关结果（包括情绪、情绪和睡眠）提供经验证据。研究结果将对临床医生和数以百万计的乳腺癌幸存者和绝经期无乳腺癌的妇女有意义，她们正在寻求经证实和可接受的非激素治疗频繁、严重和/或令人烦恼的潮热。

DESCRIPTION (provided by applicant): For millions of breast cancer survivors and menopausal women without breast cancer, hot flashes are frequent, severe, and bothersome events that can interfere with daily life and negatively influence mood, affect, and/or sleep. Unfortunately, the scientific basis for managing hot flashes is limited. The major conclusion from a recent National Institutes of Health state-of-the-science conference was that additional data are needed on the efficacy and appropriateness of non-hormonal hot flash treatments. Although slow deep breathing has been recommended by the North American Menopause Society as a first-line treatment for hot flashes, these recommendations are based on two previous studies that included small numbers of menopausal women without breast cancer, used a complex time- and resource-intensive instructional protocol, and incorporated a narrow range of outcomes. These limitations restrict current evidence for efficacy and reduce the likelihood that this promising non-hormonal hot flash treatment can be disseminated into widespread use. The proposed randomized, controlled trial evaluates a simplified DVD-based at-home slow deep breathing training and practice program against a DVD-based attention control condition of fast shallow breathing training and a no-treatment usual care control condition among breast cancer survivors and menopausal women without breast cancer. Aims are to evaluate (1) efficacy for physiologic and subjective hot flashes (objective frequency and subjective frequency, severity, bother, duration), (2) efficacy for perceived hot flash interference and associated outcomes (mood, affect, sleep), (3) differences in efficacy between breast cancer survivors and menopausal women without cancer, and (4) acceptability and usability in anticipation of disseminating findings into clinical practice (treatment acceptability, outcome expectancy, treatment credibility, and frequency of practice and application). This study will also examine baseline characteristics as potential covariates of efficacy, including objective hot flash frequency, body mass index, race, ethnicity, education, prior breath training, smoking status, menopausal status, use of selective estrogen receptor modulators or aromatase inhibitors, use of other hot flash treatments, and comorbidities. 195 breast cancer survivors and 195 menopausal women without cancer who meet inclusion criteria will be stratified and randomized to slow deep breathing, an attention control condition of fast shallow breathing, or a no-treatment usual care control group. Outcomes will be assessed at baseline and 8 and 16 weeks post-intervention by research assistants masked to randomization group. To assess treatment integrity among the slow deep breathing group, a portable respiratory transducer will be used at each data collection point to evaluate breathing depth and rate during normal breathing and slow deep breathing. Findings will provide empirical evidence for or against the use of slow deep breathing for relieving physiologic and/or subjective hot flashes, perceived hot flash interference and associated outcomes. Importantly, positive or negative findings will provide guidance for clinicians' recommendations and consumers' treatment selections either in favor of, or against, the use of slow deep breathing. If study results support efficacy, acceptability, and usability, our DVD-based intervention could be easily and widely disseminated for use in lieu of, or in addition to, existing pharmacologic or non-pharmacologic hot flash treatments. Public Health Relevance Paragraph: Findings from this study will provide empirical evidence for or against the use of slow deep breathing for relieving physiologic and/or subjective hot flashes, perceived hot flash interference and associated outcomes including mood, affect, and sleep. Findings will have relevance to clinicians and the millions of breast cancer survivors and menopausal women without breast cancer who are seeking proven and acceptable non- hormonal treatments for frequent, severe, and/or bothersome hot flashes.