MSI-FLASH: Paced Respiration for Breast Cancer Survivors

MSI-FLASH：乳腺癌幸存者的定速呼吸

• 批准号: 7923796
• 负责人: JANET S CARPENTER
• 金额: $ 30.19万
• 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: 2008-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7923796
• 关键词: Affect; American; Attention; Behavioral; Boston; Breathing; Cancer Survivor; Clinical; Complex; Controlled Study; Data; Data Coordinating Center; Expectancy; Frequencies; Home environment; Hormonal; Hot flushes; Hour; Intervention; Investigation; Laboratories; Malignant Neoplasms; Masks; Menopausal Symptom; Menopause; Moods; Negative Finding; Night Sweating; Outcome; Participant; Persons; Philadelphia; Physiological; Principal Investigator; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Relaxation; Reporting; Research; Research Personnel; Resources; Respiration; Science; Scientist; Selection for Treatments; Severities; Sex Functioning; Sexual Dysfunction; Site; Sleep; Sleep disturbances; Societies; Sweat; Sweating; Symptoms; Testing; Time; Training; Training Programs; Transducers; Treatment Efficacy; Treatment Protocols; United States National Institutes of Health; Vasomotor; Woman; Women' s Health; base; biobehavior; body-mind; clinical practice; clinical research site; disturbance in affect; effective therapy; efficacy testing; experience; hormone therapy; improved; malignant breast neoplasm; multidisciplinary; post intervention; programs; respiratory; response; secondary outcome; symposium; treatment as usual; usability

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.

描述（由申请人提供）：本申请的目的是提出一个科学家网络，他们对更年期过渡有高度的了解，并在进行妇女健康试验方面有经验，以实现本RFA的主要目标，即加速确定缓解血管舒缩症状的有效补救措施。该提案是与题为“更年期症状倡议-寻找出汗和潮热（MSI-FLASH）的持久答案”的网络一起提交的。我们的DCC将由安德里亚·拉克鲁瓦和加内特·安德森共同领导，他们在妇女健康倡议临床协调中心（西雅图）共同担任了十多年的首席研究员。MSI-FLASH网络有五个临床站点，分别位于波士顿（Lee Cohen和Hadine Joffe，私人律师）、印第安纳州印第安纳波利斯（Janet Carpenter，私人律师）、加州奥克兰（Barbara Sternfeld和Bette Caan，私人律师）、费城（Ellen Freeman，私人律师）和西雅图（Katherine Newton和Susan Reed，私人律师）。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、身心、激素和药物干预。印第安纳波利斯网站为乳腺癌幸存者提出了一项随机、受控、隐蔽的试验，将有节奏呼吸（缓慢深呼吸）的简化现场训练与现场注意力控制训练（快速浅呼吸）进行比较，并且不进行常规治疗。北美更年期协会基于先前的两项研究推荐节律呼吸作为血管舒缩症状的一线治疗方法，这两项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。这些限制限制了有效性的证据，降低了广泛传播的可能性。研究目的是评估(1)对生理和主观血管舒张性症状的疗效（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（睡眠障碍、情绪障碍、整体生活质量、性功能）的疗效，以及(3)对临床实践结果的可接受性和可用性（治疗可接受性、结果预期、治疗可信度、治疗效果）。以及练习和应用的频率)。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组。结果将在基线和干预后8周和16周由随机分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（呼吸速率和深度）。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有节奏呼吸。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在临床实践中广泛应用，代替或补充其他治疗。