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常见的癌症，据估计，2010年有207，090例新的诊断，今天出生的妇女中有八分之一的终生风险。大多数乳腺癌病例是在绝经后妇女的早期和可治疗阶段被诊断出来的，并且大多数肿瘤（70-80%）是乳腺癌受体阳性的。对于这些妇女，标准的辅助内分泌治疗是芳香化酶抑制剂（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AI的常见副作用，在临床实践中观察到的幸存者中，关节投诉的估计范围为46%至74%。AI相关肌肉骨骼症状（AIMSS）的确切病因尚不清楚，并且由于老年女性一般人群中良性和非特异性肌肉骨骼症状（如关节炎）的高患病率而变得复杂。由于副作用严重性而导致的AI停药估计为20- 32%，并且在肿瘤学家中引起了极大的关注。需要进行研究，以确定有效，易于使用，可持续和安全的AIMSS管理替代或辅助方法，以便乳腺癌幸存者能够继续接受AI治疗，并拥有尽可能无痛的生活。 我们建议调查中等强度的体力活动（PA）是否可以在接受AI治疗的女性乳腺癌幸存者样本中缓解AIMSS，这些患者报告中度至重度关节症状。具体来说，我们建议调整和测试关节炎基金会的轻松行走（WWE）计划，该计划以证据为基础，可减少关节炎成人的关节疼痛，僵硬和疲劳，并以自我指导（非团体）的形式提供。我们的“概念验证”假设是：（a）针对我们的目标患者人群调整WWE是可行的，（B） 适应性WWE可以为患有AIMSS的患者提供类似于患有关节炎的成年人的关节疼痛/症状缓解。为了研究这些假设，我们提出：（1）基于对乳腺癌幸存者（N=20）的访谈，开发WWE-乳腺癌（WWE-BC）的初步适应性，重点关注参与PA的障碍和促进因素;（2）在新的幸存者样本（N=60）中对WWE-BC的影响进行初步评估，涉及（a）从事PA，（B）控制关节疼痛/症状，（c）继续接受人工智能治疗;以及（3）根据与幸存者和肿瘤科医生、执业护士和护士导航员的访谈，制定WWE-BC信息和沟通策略。通过本研究收集的关于WWE-BC的可接受性、可行性、安全性和承诺的数据将为更大规模研究的开发提供信息，以测试WWE-BC的有效性，识别潜在效应介质和/或调节剂，并建立普遍性。我们研究的所有方面将由我们研究团队的患者顾问以及积极参与我们研究设计、实施和分析的肿瘤学家提供信息。

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.