Physical activity to reduce joint pain during aromatase inhibitor therapy

芳香酶抑制剂治疗期间进行体力活动可减轻关节疼痛

• 批准号: 8581092
• 负责人: LEIGH Fleming CALLAHAN
• 金额: $ 16.84万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-12 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8581092
• 关键词: Address; Adherence; Adjuvant; Adult; Adverse effects; Adverse event; Am 80; Aromatase Inhibitors; Arthralgia; Arthritis; Benign; Cancer Patient; Cancer Survivor; Cardiovascular system; Clinic; Clinic Visits; Communication; Data; Development; Diagnosis; Disease-Free Survival; Dose; Effectiveness; Endocrine; Epidemiologic Studies; Etiology; Evaluation; Fatigue; Female Breast Carcinoma; Foundations; Future; General Population; General Practices; Health Promotion; High Prevalence; Hormone Receptor; Hormones; Internal Medicine; Intervention; Intervention Trial; Interview; Joints; Life; Malignant Neoplasms; Manuscripts; Mediator of activation protein; Musculoskeletal; National Cancer Institute; Non-Steroidal Anti-Inflammatory Agents; Nurse Practitioners; Nurses; Oncologist; Outcome; Pain-Free; Participant; Patients; Physical activity; Physicians; Postmenopause; Production; Qualitative Research; Quality of life; Randomized Controlled Trials; Recruitment Activity; Recurrence; Reporting; Research; Safety; Sampling; Self Efficacy; Self Medication; Severities; Site; Staging; Summary Reports; Survivors; Symptoms; Target Populations; Testing; Time; Visit; Waiting Lists; Walking; Woman; abstracting; base; clinical practice; design; evidence base; experience; flyer; follow-up; improved; interest; lifetime risk; malignant breast neoplasm; new technology; older women; oncology; patient population; primary outcome; programs; public health relevance; satisfaction; secondary outcome; symptom management; tumor

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.

描述(申请人提供)：乳腺癌是美国女性中第二常见的癌症，2010年估计有207,090例新诊断，在今天出生的女性中，终身风险为八分之一。大多数乳腺癌病例是在绝经后早期和可治疗的阶段被诊断出来的，她们的大多数肿瘤(70%-80%)是激素受体阳性的。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/酸痛是人工智能的常见副作用，在临床实践中看到的幸存者中，关节主诉的估计从46%到74%不等。AI相关肌肉骨骼症状(AIMSS)的确切病因尚不清楚，并因良性和非特异性肌肉骨骼症状在一般老年女性人群中的高发病率而复杂化，如关节炎。由于副作用严重而停用人工智能的比例估计为20-32%，这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人工智能治疗，并尽可能地过上无痛的生活。我们建议在接受人工智能治疗的女性乳腺癌幸存者中，研究中等强度的体力活动(PA)是否可以缓解AIMSS，这些女性报告了中度到重度的关节症状。具体地说，我们建议调整和测试关节炎基金会的轻松行走(WWE)计划，该计划是以证据为基础的，用于减少成人关节炎患者的关节疼痛、僵硬和疲劳，并以自我指导(非团体)的形式提供。我们的“概念证明”假设是：(A)使WWE适应我们的目标患者群体是可行的，以及(B) 改装的WWE可以为AIMSS患者提供关节疼痛/症状的缓解，类似于成人关节炎患者。为了研究这些假设，我们建议：(1)基于对乳腺癌幸存者(N=20)的访谈，制定WWE-乳腺癌的初步适应(WWE-BC)，重点关注参与PA的障碍和促进者；(2)在新的幸存者样本(N=60)中，就(A)参与PA，(B)控制关节疼痛/症状和(C)继续接受人工智能治疗，对WWE-BC的效果进行初步评估；以及(3)基于对幸存者和肿瘤医生、护士和护士导航员的采访，制定WWE-BC的信息和沟通策略。通过这项研究收集的关于WWE-BC的可接受性、可行性、安全性和前景的数据将有助于开展一项更大规模的研究，以测试WWE-BC的有效性，确定潜在的影响调解人和/或主持人，并建立普适性。我们研究的所有方面都将由我们研究团队中的患者顾问以及积极参与我们研究的设计、实施和分析的肿瘤学家提供信息。