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.
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