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

基于互联网的生活方式干预，消除前列腺癌幸存者的肥胖虚弱 (iLIVE)

基本信息

批准号：
10678740
负责人：
Wendy Demark-Wahnefried
金额：
$ 58.76万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-22 至 2028-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10678740
关键词：
Acceleration Address Affect African American Age American Society of Clinical Oncology Behavioral Body Weight decreased Body mass index Cancer Survivor Caring Clinical Data Diet Dietary Intervention Dose Effectiveness of Interventions Elderly Exercise Fatigue Fatty acid glycerol esters Foundations Functional disorder Guidelines Health Health Care Costs Hospitalization Hybrids Individual Internet Intervention Life Style Measures Morbidity - disease rate Muscular Atrophy National Comprehensive Cancer Network Obesity Oncology Online Systems Outcome Pathway interactions Persons Phenotype Physical Function Physical activity Populations at Risk Practice Guidelines Prevalence Principal Investigator Proctor framework Public Health Quality of life Race Randomized Recurrence Risk Rural Science Self Direction Solid Speed Testing Therapeutic Training Training Programs Underrepresented Populations Urology Videoconferencing Weight Gain Weight maintenance regimen Work androgen deprivation therapy arm cancer survival clinical care clinical practice combat cost design dietary disability effective intervention effectiveness testing effectiveness/implementation trial exercise intervention fall risk falls follow-up frailty functional decline future implementation health economics high risk population implementation outcomes implementation science implementation strategy innovation intervention effect lifestyle intervention men mortality multidisciplinary nutrition oncology trial online delivery primary endpoint programs prostate cancer prevention prostate cancer progression prostate cancer survivors recruit remote delivery resistance exercise sarcopenia secondary outcome standard care theories treatment as usual tumor progression weight loss program

项目摘要

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.

美国有超过 100 万男性正在接受雄激素剥夺疗法 (ADT) 以预防前列腺癌进展。尽管 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，即与非使用者相比，ADT 使用者的肥胖虚弱程度高出 19 倍，并且肥胖虚弱是一个显着的且比单独的虚弱更能预测反复跌倒。因此，迫切需要采取干预措施来缓解 PCS 中的肥胖虚弱威胁着独立性和生活质量，并使医疗保健成本成倍增加。然而，目前临床实践中尚无针对肥胖衰弱的 PCS 有效干预措施。临床终点。鉴于 ADT 上的 PC 数量每年增长超过 30,000 台，因此存在一个关键问题需要制定具有高影响力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。本申请的联合首席研究员均拥有丰富的前期工作经验展示通过在线饮食干预减少肥胖的功效以及通过在线监督减少虚弱的功效分别进行阻力训练。现在迫切需要通过 ADT 解决 PCS 肥胖虚弱问题将这些干预措施结合到一个可扩展的在线计划中。为推动这项工作走向临床实践中，我们强大的多学科专家团队包括营养学、运动科学、泌尿学、肿瘤学、行为理论、健康经济学和实施科学，提出了一个 2 臂平行组随机 I 型混合有效性实施试验的重点是 ADT 治疗 PCS 中的肥胖虚弱。这设计允许正式测试在线自我指导减肥+基于团体的组合的有效性阻力训练计划（基于互联网的生活方式干预消除前列腺肥胖衰弱癌症幸存者：iLIVE）与以肥胖虚弱作为主要终点的常规护理相比。我们的主要目标是比较 iLIVE 与 UC 在 6 个月内接受 ADT 治疗的 250 例患者的肥胖虚弱情况。次要目标是：a) 比较 iLIVE 与 UC 对次要结果的影响，例如个体虚弱标准、饮食质量、身体机能、生活质量； b) 通过比较 12 个月的组别来评估 iLIVE 与 UC 的持久性后续行动； c) 探索与干预效果相关的潜在调节因素（例如年龄、种族、BMI）。最后，我们的第三目标是：评估关键实施成果（例如成本、可接受性）以指导未来有关将 iLIVE 实施到临床护理途径的研究。 iLIVE 建立在坚实的基础上癌症幸存者饮食和运动干预的基础已被证实有效，以及拟议的 I 型混合有效性实施试验旨在加速有效性测试和优化，最终能够降低全国超过 100 万老年 PCS 的发病率和死亡率。