MSI-FLASH: Paced Respiration for Breast Cancer Survivors

描述(申请人提供)：本申请的目的是建议建立一个科学家网络，他们对更年期过渡有高度的了解，并在妇女健康试验的实施方面经验丰富，以实现本RFA的主要目标，即加速寻找有效的药物来缓解血管舒缩症状。这项建议是与题为“更年期症状倡议-寻找汗水和潮热的持久答案(MSI-FLASH)”的网络一起提交的。我们的DCC将由Andrea LaCroix和Garnet Anderson共同领导，他们一起担任西雅图临床协调中心(妇女健康倡议)的联合首席研究员已有十多年。MSI-Flash网络有五个临床站点，分别位于波士顿(Lee Cohen和Hadine Joffe，PI)、印第安纳波利斯、IN(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·牛顿和苏珊·里德，PI)。这个多学科研究小组提出了五项随机对照试验，测试一系列行为、精神-身体、激素和药物干预。印第安纳波利斯网站提出了一项针对乳腺癌幸存者的随机、对照、蒙面试验，比较了简化的有节奏呼吸(慢速深呼吸)面对面培训与面对面注意力控制培训计划(快浅呼吸)和不进行治疗的常规护理。起搏呼吸是北美更年期协会推荐的血管运动症状的一线治疗方法，基于之前的两项研究，这两项研究排除了乳腺癌幸存者，使用了复杂的耗时和资源密集型教学方案，并纳入了狭窄的结果范围。这些限制限制了有效性的证据，并降低了广泛传播的可能性。研究的目的是评估(1)对生理和主观血管舒缩症状(客观频率和主观频率、严重程度、困扰、干扰)的疗效，(2)对其他更年期症状(睡眠障碍、情绪障碍、总体生活质量、性功能)的疗效，以及(3)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、结果、治疗可信度、实践和应用的频率)。来自MSI-Flash网络的总共336名符合条件的乳腺癌幸存者将被随机分配到干预、注意力控制或常规护理中。结果将在基线和干预后8周和16周由随机组的数据收集者进行评估。便携式呼吸传感器将用于评估治疗的完整性(呼吸频率和深度)。积极或消极的结果将为临床医生的建议和消费者的治疗选择提供指导，无论是支持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很容易地广泛应用于临床实践，以取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.