MSI-FLASH: Paced Respiration for Breast Cancer Survivors

描述（由申请人提供）：本申请的目的是提出一个科学家网络，这些科学家对绝经过渡期有很深的了解，并在进行女性健康试验方面有丰富的经验，以实现本RFA的主要目标，即加速识别缓解血管痉挛症状的有效补救措施。这项建议是与题为"月经症状倡议-寻找出汗和潮热的持久答案"的网络一起提交的。我们的DCC将由Andrea LaCroix和Garnet安德森共同领导，他们曾共同担任妇女健康倡议临床协调中心（西雅图）的联合主要研究者十多年。MSI-FLASH网络有5个临床研究中心，分别位于波士顿（Lee Cohen和Hadine Joffe，PI）、印第安纳波利斯（Janet Carpenter，PI）、加利福尼亚州奥克兰（Barbara Sternfeld和Bette Caan，PI）、费城（Ellen Freeman，PI）和西雅图（凯瑟琳牛顿和Susan Reed，PI）。这个多学科的研究小组提出了五项随机对照试验，测试一系列的行为，身心，激素和药物干预。印第安纳波利斯研究中心提出了一项针对乳腺癌幸存者的随机、对照、设盲试验，比较了简化的现场呼吸节奏训练（缓慢深呼吸）与现场注意力控制训练计划（快速浅呼吸）以及无治疗常规护理。北美更年期协会建议将起搏呼吸作为血管痉挛症状的一线治疗，这是基于之前的两项研究，这些研究排除了乳腺癌幸存者，使用了复杂的时间和资源密集型指导方案，并纳入了狭窄的结果范围。这些局限性限制了疗效的证据，降低了广泛传播的可能性。研究目的是评价（1）对生理和主观血管扩张症状的疗效（客观频率和主观频率，严重程度，困扰，干扰），（2）对其他更年期症状的疗效（睡眠障碍、情绪障碍、总体生活质量、性功能）和（3）预期将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频率）。 来自MSI-FLASH网络的336名符合条件的乳腺癌幸存者将随机接受干预、注意力控制或常规护理。将由对随机分组设盲的数据收集者在基线和干预后8周和16周评估结局。将使用便携式呼吸传感器评估治疗完整性（呼吸频率和深度）。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起搏呼吸。如果研究结果支持有效性、可接受性和可用性，这种简化的干预措施可以在临床实践中轻松广泛地替代或补充其他治疗方法。

DESCRIPTION (provided by applicant): The purpose of this application is to propose a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials to fulfill the main objective of this RFA which is to accelerate the identification of effective remedies to relieve vasomotor symptoms. This proposal is being submitted in conjunction with the network entitled, "Menopausal Symptoms Initiative- Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)". Our DCC will be jointly led by Andrea LaCroix and Garnet Anderson who have served together as Co-Principal Investigators of the Women's Health Initiative, Clinical Coordinating Center (Seattle) for more than a decade. The MSI-FLASH network has five clinical sites located in Boston (Lee Cohen and Hadine Joffe, PIs), Indianapolis, IN (Janet Carpenter, PI), Oakland, CA (Barbara Sternfeld and Bette Caan, PIs), Philadelphia (Ellen Freeman, PI), and Seattle (Katherine Newton and Susan Reed, Pis). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions. The Indianapolis site proposes a randomized, controlled, masked trial for breast cancer survivors comparing simplified in-person training in paced respiration (slow deep breathing) to an in-person attention control training program (fast shallow breathing) and no treatment usual care. Paced respiration is recommended by the North American Menopause Society as a first-line treatment for vasomotor symptoms based on two previous studies that excluded breast cancer survivors, used a complex time- and resource-intensive instructional protocol, and incorporated a narrow range of outcomes. These limitations restrict evidence for efficacy and reduce the likelihood of widespread dissemination. Study aims are to evaluate (1) efficacy for physiologic and subjective vasomotor symptoms (objective frequency and subjective frequency, severity, bother, interference), (2) efficacy for other menopausal symptoms (sleep disturbance, mood disturbance, overall quality of life, sexual function) and (3) acceptability and usability in anticipation of disseminating findings into clinical practice (treatment acceptability, outcome expectancy, treatment credibility, and frequency of practice and application). A total of 336 eligible breast cancer survivors from across the MSI-FLASH network will be randomized to intervention, attention control, or usual care. Outcomes will be assessed at baseline and 8 and 16 weeks post-intervention by data collectors masked to randomization group. Portable respiratory transducers will be used to assess treatment integrity (rate and depth of breathing). Positive or negative findings will provide guidance for clinicians' recommendations and consumers' treatment selections either in favor of, or against, the use of paced respiration. If findings support efficacy, acceptability, and usability, this simplified intervention could be easily and widely used in clinical practice in lieu of, or in addition to, other treatments.