Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)

美国有100多万男性正在接受雄激素剥夺疗法(ADT)以预防前列腺癌 进步。虽然ADT是一种重要的治疗策略，但它会增加虚弱、体重增加和肥胖的风险。 前列腺癌幸存者(PCS)。在我们最近的研究中，PCS同时患有肥胖和虚弱的几率，即， ADT使用者的肥胖脆弱程度是非ADT使用者的19倍，并且肥胖脆弱是显著的 对反复跌落的预测比仅仅是脆弱更强。因此，迫切需要干预措施来缓解 PCS中的肥胖脆弱，威胁到独立性和生活质量，并增加了医疗保健成本。 然而，目前在PCS的临床实践中还没有有效的干预措施将肥胖虚弱作为一种 临床终点。鉴于ADT上的PC数量每年以超过30,000的速度增长，因此有一个关键的 需要开发具有高覆盖潜力的可扩展干预措施，以解决这一紧迫的实践差距和不断上升的问题 公共卫生问题。本申请的联合首席调查员每人都有很强的前期工作 通过在线饮食干预展示减肥效果，通过在线监督展示脆弱 分别进行抗阻训练。迫切需要解决ADT上PCS中的肥胖脆弱问题，现在支持 将这些干预措施合并到一个可扩展的在线计划中。把这项工作推向临床 实践，我们强大的多学科专家团队，在营养，运动科学，泌尿外科，肿瘤学， 行为理论、健康经济学和实施科学提出了一个双臂平行小组 随机I型混合有效性-实施试验集中在ADT的PCS中的肥胖脆弱性。这 设计允许正式测试在线、自我定向减肥+基于团体的组合的有效性 抵抗训练计划(基于互联网的生活方式干预，以消除前列腺癌中的肥胖脆弱 癌症幸存者：iLIVE)与以肥胖虚弱为主要终点的常规护理相比。我们的主要目标是 比较iLIVE和UC在6个月的ADT治疗中250个PCS中的肥胖脆弱程度。次要目标是：a) 比较iLIVE和UC对二次结局的影响，例如，个体脆弱标准、饮食质量、 身体功能、生活质量；b)通过比较12个月龄组评估iLIVE对UC的耐受性 跟踪；以及c)探索与干预效果相关的潜在调节因素(例如，年龄、种族、体重指数)。 最后，我们的第三个目标是：评估关键的实施成果(例如，成本、可接受性)，以指导未来 ILIVE在临床护理路径中实施的研究。ILIVE建立在固体上 已证实有效的癌症幸存者饮食和运动干预的基础，以及拟议的I型 混合有效性-实施试验旨在加快有效性测试和优化以及 最终能够降低全国100多万例老年PCS的发病率和死亡率。

Over 1 million men in the U.S. are receiving androgen deprivation therapy (ADT) to prevent prostate cancer progression. Although a critical therapeutic strategy, ADT increases the risk of frailty, weight gain and obesity in prostate cancer survivors (PCS). In our recent study, the odds of PCS having both obesity plus frailty, i.e., obese frailty, were 19x higher in ADT users compared to non-users and obese frailty was a significant and stronger predictor of recurrent falls than frailty alone. Thus, interventions are urgently needed to mitigate the obese frailty in PCS that threatens independence and quality of life and which multiplies health care costs. However, there are currently no effective interventions in clinical practice for PCS that target obese frailty as a clinical endpoint. Given that the number of PCS on ADT is growing by over 30,000 each year, there is a critical need to develop scalable interventions with high reach potential to address this urgent practice gap and rising public health issue. The co-principal investigators for this application each have strong prior work demonstrating efficacy for reducing obesity via online dietary intervention and frailty via online supervised resistance training, respectively. The urgent need to address obese frailty in PCS on ADT now supports combining these interventions into a single, scalable online program. To advance this work toward clinical practice, our strong multidisciplinary team of experts in nutrition, exercise science, urology, oncology, behavioral theory, health economics, and implementation science, proposes a 2-arm parallel group randomized Type I hybrid effectiveness-implementation trial focused on obese frailty in PCS on ADT. This design allows formal testing of the effectiveness of a combined online, self-directed weight loss + group-based resistance training program (Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors: iLIVE) against usual care with obese frailty as a primary endpoint. Our Primary Aim is to compare iLIVE to UC on obese frailty in 250 PCS on ADT over a 6-month period. Secondary Aims are to: a) Compare the effect of iLIVE to UC on secondary outcomes, e.g., individual frailty criterion, dietary quality, physical function, quality of life; b) Assess the durability of iLIVE to UC by comparing groups at 12-month follow-up; and c) Explore potential moderators (e.g., age, race, BMI) associated with intervention effectiveness. Finally, our Tertiary Aim is to: Assess key implementation outcomes (e.g., cost, acceptability) to guide future research regarding the implementation of iLIVE into the clinical care pathway. iLIVE builds on a solid foundation of diet and exercise interventions in cancer survivors with proven efficacy, and the proposed Type I hybrid effectiveness-implementation trial is designed to speed effectiveness testing and optimization and ultimately enable reductions in morbidity and mortality for over 1 million older PCS across the nation.