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

针对潮热、干扰和相关结果的呼吸干预

• 批准号: 7776939
• 负责人: JANET S CARPENTER
• 金额: $ 31.33万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-12 至 2012-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7776939
• 关键词: Affect; American; Aromatase Inhibitors; Attention; Body mass index; Breathing; Cancer Survivor; Characteristics; Comorbidity; Complex; Control Groups; Controlled Study; Data; Data Collection; Education; Ethnic Origin; Event; Expectancy; Frequencies; Home environment; Hormonal; Hot flushes; Hour; Instruction; Intervention; Investigation; Laboratories; Life; Malignant Neoplasms; Masks; Menopausal Status; Menopause; Moods; Negative Finding; Outcome; Participant; Physiological; Protocols documentation; Race; Randomized; Randomized Controlled Trials; Recommendation; Relaxation; Reporting; Research; Resources; Science; Selection for Treatments; Selective Estrogen Receptor Modulators; Severities; Sleep; Sleep disturbances; Smoking Status; Societies; Time; Training; Transducers; Treatment Efficacy; Treatment Protocols; United States National Institutes of Health; Woman; Women' s Health; base; clinical practice; disturbance in affect; effective therapy; hormone therapy; inclusion criteria; malignant breast neoplasm; meetings; post intervention; programs; public health relevance; respiratory; risk benefit ratio; symposium; treatment as usual; usability

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.

描述（由申请人提供）： 对于数以百万计的乳腺癌幸存者和绝经期妇女没有乳腺癌，潮热是频繁的，严重的，和麻烦的事件，可以干扰日常生活和负面影响情绪，影响，和/或睡眠。不幸的是，管理潮热的科学基础是有限的。美国国立卫生研究院最近的一次科学状态会议的主要结论是，需要更多关于非激素性潮热治疗的有效性和适当性的数据。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，其中包括少数未患乳腺癌的绝经期妇女，使用了复杂的时间和资源密集型指导方案，并纳入了窄范围的结果。这些局限性限制了目前的疗效证据，并降低了这种有前途的非激素性潮热治疗广泛使用的可能性。拟议的随机对照试验评估了简化的DVD为基础的家庭慢深呼吸训练和实践计划对DVD为基础的注意力控制条件的快速浅呼吸训练和无治疗的常规护理控制条件之间的乳腺癌幸存者和绝经期妇女没有乳腺癌。目的是评价（1）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）感觉到的潮热干扰的有效性和相关结果（情绪、情感、睡眠），（3）乳腺癌幸存者与未患癌症的绝经期妇女之间的疗效差异，和（4）预期将研究结果传播到临床实践中的可接受性和可用性（治疗可接受性、预期结果、治疗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疗效的潜在协变量，包括客观潮热频率、体重指数、人种、种族、教育、既往呼吸训练、吸烟状态、绝经状态、选择性雌激素受体调节剂或芳香酶抑制剂的使用、其他潮热治疗的使用和合并症。将对195名符合入选标准的乳腺癌幸存者和195名绝经期无癌症女性进行分层，并随机分配至缓慢深呼吸组、快速浅呼吸的注意力控制组或无治疗常规护理对照组。将由对随机分组设盲的研究助理在基线和干预后8周和16周评估结局。为了评估缓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，以评价正常呼吸和缓慢深呼吸期间的呼吸深度和速率。研究结果将提供支持或反对使用缓慢深呼吸缓解生理和/或主观潮热、感知潮热干扰和相关结局的经验证据。重要的是，积极或消极的发现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的干预可以容易地广泛传播，以代替或补充现有的药物或非药物性潮热治疗。 公共卫生相关性段落：本研究的结果将提供经验证据，支持或反对使用缓慢深呼吸缓解生理和/或主观潮热，感知潮热干扰和相关结果，包括情绪，情感和睡眠。研究结果将与临床医生和数百万乳腺癌幸存者和未患乳腺癌的绝经期妇女相关，这些妇女正在寻求经证实和可接受的非激素治疗，以治疗频繁、严重和/或令人烦恼的潮热。