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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.

在美国，超过100万男性正在接受雄激素剥夺治疗（ADT）以预防前列腺癌。进展虽然ADT是一种关键的治疗策略，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同时具有肥胖和虚弱的几率，即， ADT使用者的肥胖虚弱，是非使用者的19倍，肥胖虚弱是一个显著的，比单纯虚弱更能预测复发性福尔斯。因此，迫切需要采取干预措施， PCS中的肥胖虚弱，威胁独立性和生活质量，并使医疗保健费用成倍增加。然而，在临床实践中，目前还没有针对肥胖虚弱的PCS的有效干预措施，临床终点鉴于ADT上的PCS数量每年增长超过30，000，需要制定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，公共卫生问题。该应用程序的共同主要研究者都有很强的前期工作通过在线饮食干预证明减少肥胖的有效性，通过在线监督分别进行阻力训练。现在迫切需要解决ADT上PCS中的肥胖脆弱性，将这些干预措施整合到一个单一的、可扩展的在线项目中。为了将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，泌尿科，肿瘤学，行为理论，卫生经济学和实施科学，提出了一个双臂平行组随机I型混合有效性-实施试验，重点关注ADT治疗PCS中的肥胖虚弱。这设计允许正式测试的有效性相结合的在线，自我导向的减肥+基于组抵抗力训练计划（基于互联网的生活方式干预，以消除前列腺肥胖脆弱癌症幸存者：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例肥胖虚弱患者中的疗效。第二个目标是：a）比较iLIVE与UC对次要结局的影响，例如，个体虚弱标准，膳食质量，身体功能、生活质量; B）通过比较12个月时的组，评估iLIVE对UC的持久性跟进;以及c）探索潜在的主持人（例如，年龄、种族、BMI）与干预效果相关。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），以指导未来关于将iLIVE应用于临床护理路径的研究。iLIVE建立在一个坚实的在癌症幸存者中建立饮食和运动干预的基础，并证明其有效性，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100多万老年PCS的发病率和死亡率。