Physical activity to reduce joint pain during aromatase inhibitor therapy

描述（由申请人提供）：乳腺癌是美国女性中第二大常见癌症，2010年估计有207,090例新诊断，今天出生的女性中有八分之一的终生风险。大多数乳腺癌病例在绝经后妇女中被诊断为早期和可治疗阶段，并且大多数肿瘤（70-80%）是激素受体阳性。对于这些女性，标准的辅助内分泌治疗是芳香酶抑制剂（AI）治疗，以延长无病生存期和复发时间。不幸的是，关节疼痛/僵硬/疼痛是AIs的常见副作用，在临床实践中，幸存者中关节主诉的比例估计在46%到74%之间。人工智能相关的肌肉骨骼症状（AIMSS）的确切病因尚不清楚，并且在一般老年妇女人群中，如关节炎等良性和非特异性肌肉骨骼症状的高患病率使其复杂化。据估计，由于副作用严重而停用人工智能的比例为20-32%，这是肿瘤学家非常关注的问题。需要进行研究，以确定有效、易于使用、可持续和安全的替代或辅助方法来管理AIMSS，以便乳腺癌幸存者能够继续接受人工智能治疗，并尽可能地过上无痛的生活。我们建议研究中等强度的体育活动（PA）是否可以在接受AI治疗并报告中度至重度关节症状的女性乳腺癌幸存者样本中缓解AIMSS。具体而言，我们建议调整和测试关节炎基金会的轻松行走（WWE）计划，该计划以自我指导（非团体）形式提供，以减少关节炎成人的关节疼痛，僵硬和疲劳为证据。我们的“概念验证”假设是：(a)适用于我们的目标患者群体的WWE是可行的；(b)

DESCRIPTION (provided by applicant): Breast cancer is the second most common cancer among women in the U.S., with an estimated 207,090 new diagnoses in 2010 and a lifetime risk among women born today of 1 in 8. Most breast cancer cases are diagnosed among postmenopausal women at an early and treatable stage, and most of their tumors (70-80%) are hormone-receptor positive. For these women, standard adjuvant endocrine treatment is aromatase inhibitor (AI) therapy to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/ achiness is a common side-effect of AIs, with estimates of joint complaints ranging from 46% to 74% among survivors seen in clinical practice. The precise etiology of AI-associated musculoskeletal symptoms (AIMSS) remains unclear and is complicated by the high prevalence of benign and non-specific musculoskeletal symptoms in the general population of older women, such as arthritis. AI discontinuation due to side-effect severity is an estimated 20-32%, and is of great concern among oncologists. Research is needed to identify effective, easy-to-use, sustainable, and safe alternative or adjunct approaches to AIMSS management, so that breast cancer survivors are able to remain on AI therapy and have a life that is as pain-free as possible. We propose to investigate whether moderate-intensive physical activity (PA) can provide relief from AIMSS within a sample of female breast cancer survivors on AI therapy who report moderate to severe joint symptoms. Specifically, we propose to adapt and test the Arthritis Foundation's Walk With Ease (WWE) program, which is evidence-based for reducing joint pain, stiffness and fatigue among adults with arthritis and is available in a self-directed (non-group) format. Our "proof of concept" hypotheses are that: (a) it is feasible to adapt WWE for our target patient population and (b) that an adapted WWE can provide joint pain/symptom relief for patients with AIMSS similar to that of adults with arthritis. To investigate these hypotheses, we propose to: (1) develop an initial adaptation of WWE-Breast Cancer (WWE-BC) based on interviews with breast cancer survivors (N=20) focused on barriers and facilitators to engaging in PA; (2) conduct a preliminary assessment of the effect of WWE-BC within a new sample of survivors (N=60) with regard to (a) engaging in PA, (b) managing joint pain/symptoms and (c) remaining on AI therapy; and (3) develop WWE-BC messages and communication strategies based on interviews with survivors and oncology physicians, nurse practitioners and nurse navigators. Data on the acceptability, feasibility, safety and promise of WWE-BC gathered through this study will inform the development of a larger study to test the effectiveness of WWE-BC, identify potential effect mediators and/or moderators, and establish generalizability. All aspects of our study will be informed by Patient Advisors who are part of our Study Team as well as by oncologists who are actively engaged in the design, implementation and analysis of our study.