Disseminating PAL

描述（由申请人提供）：目前在美国有超过240万乳腺癌（BrCa）幸存者。作为BrCa治疗的常见和病态的影响，淋巴水肿是长期幸存者关注的主要问题。淋巴水肿引起肢体肿胀和不适，严重损害手臂功能。虽然发病率通常在20-30%之间，但淋巴水肿对所有BrCa幸存者都有负面影响，因为危险因素不明确，而且这种疾病是慢性、进行性和不可治愈的。长期以来，临床医生一直建议乳腺癌幸存者避免用受影响的手臂举重，以避免淋巴水肿的发生或恶化。最近完成的体力活动和淋巴水肿试验（PAL）的结果提供了令人信服的证据，证明这种善意的风险规避建议是错误的。PAL试验在一项大样本量的研究中证实了重量训练干预预防淋巴水肿发作的有效性。重量训练干预也改善了肌肉力量和自我感知的力量和健康，外观和性。媒体的关注和形成性的评估工作表明，乳腺癌患者和临床医生社区有兴趣广泛传播这种创新的干预措施，如果它可以安全地完成。下一步是开发和评估沟通渠道和基础设施，以提供广泛传播、强调安全且仍然有效的经修订的PAL干预方法。这项探索性研究将试点测试一种经过修订的干预交付方法，特别是根据临床医生和幸存者对安全性的担忧。在肿瘤随访期间，在Rena Rowan乳腺中心就诊的幸存者将收到肿瘤临床医生的转诊，对手臂和肩部问题进行标准化的物理治疗评估（和治疗，如果需要的话），包括但不限于淋巴水肿。经过物理治疗师的许可后，120名幸存者将参加四组物理治疗课程。在这些课程中，幸存者将学习安全有效执行PAL重量训练方案的基本要素。在此之后，每位女性都可以选择在家中或社区基督教青年会参加PAL举重项目。物理治疗评估，治疗（如果需要），以及学习PAL举重项目的小组会议的费用都将由参与者的保险支付。由于这不是他们治愈性治疗的一部分（例如，这是可选的），预计一些幸存者将选择不参加某些或所有这些提供的干预措施。将收集数据，以帮助解释拟议方法的哪些要素有助于或阻碍更广泛地传播和采用这种方法来提供PAL干预措施。干预措施的评估将以创新传播模型的构建为指导，该模型有助于解释传播成功，包括相对优势、兼容性、复杂性、可试验性和观察结果。这项试点研究的结果将用于进一步修订PAL干预交付方法，以开展更大规模的推广试验。

DESCRIPTION (provided by applicant): There are more than 2.4 million breast cancer (BrCa) survivors living in the U.S. today. As a common and morbid effect of BrCa treatment, lymphedema ranks principal among concerns of long-term survivors. Lymphedema causes limb swelling and discomfort, significantly impairing arm function. Though incidence is commonly quoted to be between 20-30%, lymphedema negatively affects all BrCa survivors because risk factors are ill-defined and the condition is chronic, progressive, and incurable. Breast cancer survivors have long been advised by clinicians to avoid lifting with the affected arm to avoid onset or worsening of lymphedema. The results of the recently completed Physical Activity and Lymphedema Trial (PAL) provide compelling evidence that this well-meaning risk-averse advice to avoid lifting was in error. The PAL Trial established the effectiveness of a weight-training intervention to prevent lymphedema flare-ups in a study with a large sample size. The weight-training intervention also improved muscle strength and self perception of strength and health, appearance and sexuality. Media attention and formative assessment work indicate that the breast cancer patient and clinician communities are interested in broad dissemination of this innovative intervention if it can be done safely. The next step is to develop and assess communication channels and infrastructure for a revised method of PAL intervention delivery that is broadly disseminable, emphasizes safety and is still effective. This exploratory study will pilot test a revised intervention delivery approach specifically informed by clinician and survivor concerns for safety. During an oncology follow-up visit, survivors seen at the Rena Rowan Breast Center will receive a referral from an oncology clinician for a standardized physical therapy evaluation (and treatment, if needed) of arm and shoulder problems, including but not limited to lymphedema. After clearance from a physical therapist, 120 survivors will participate in four group physical therapy sessions. During these sessions, survivors will learn essential elements of safe and effective performance of the PAL weight-training protocol. After this, each woman will be provided options to participate in the PAL weight-lifting program in their home or at a community YMCA. The cost of the physical therapy evaluation, treatment (if needed), and group sessions to learn the PAL weight-lifting program will all be paid for by the participant's insurance. As this is not a part of their curative therapy (e.g., it is optional), it is anticipated that some survivors will choose not to participate in some or all of this offered intervention. Data will be collected to help explain what elements of the proposed approach facilitate or prevent broader dissemination and uptake of this approach to delivering the PAL intervention. Evaluation of the intervention will be guided by Dissemination of Innovation Model constructs that help explain dissemination success, including relative advantage, compatibility, complexity, trialability, and observed results. Results of this pilot study will be used to further revise the PAL intervention delivery approach to develop a larger dissemination trial. PUBLIC HEALTH RELEVANCE: The exciting results of the recently completed Physical Activity and Lymphedema (PAL) trial have been received enthusiastically by the breast cancer clinical treatment and survivorship communities. However, there are questions as to how best to deliver this successful, safe, and effective YMCA based weight-lifting intervention for breast cancer survivors. The proposed exploratory study is intended to test an intervention delivery system that will reach many survivors, emphasizes patient safety, and still links the survivor back to her community YMCA for long-term support of weight-lifting activities.