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.

美国超过100万男性正在接受雄激素剥夺疗法（ADT），以防止前列腺癌进展。尽管一种关键的治疗策略，但ADT增加了体重，体重增加和肥胖的风险在前列腺癌幸存者（PC）中。在我们最近的研究中，具有肥胖和脆弱的PC的几率，即与非用户相比，ADT使用者的肥胖脆弱性高19倍，肥胖的脆弱是重要的，并且复发性跌落比单独脆弱的预测因子更强。因此，迫切需要干预措施来减轻肥胖的PC中肥胖会威胁到独立性和生活质量，并增加医疗保健费用。但是，目前尚无针对肥胖脆弱的PC的临床实践干预措施临床终点。鉴于ADT上的PC数量每年增长30,000多个，因此有一个关键需要开发具有高潜力的可扩展干预措施，以解决这种紧急练习差距和上升公共卫生问题。该应用程序的联合主要调查员每个人都有强大的事先工作通过在线饮食干预和在线监督下，通过在线饮食干预和脆弱来证明减少肥胖的功效抵抗训练分别。迫切需要解决ADT上PC中肥胖的脆弱性现在支持将这些干预措施组合为一个可扩展的在线程序。将这项工作推向临床实践，我们坚强的营养，运动科学，泌尿外科，肿瘤学专家的多学科团队，行为理论，卫生经济学和实施科学提出了一个2臂并行群体 I型混合有效性 - 实施试验的重点是ADT上的PC中的肥胖。这设计允许正式测试合并的在线，自我指导的减肥 +基于组的有效性抵抗培训计划（基于Internet的生活方式干预以消除前列腺中的肥胖脆弱癌症幸存者：反对通常的护理，以肥胖的脆弱为主要终点。我们的主要目的是在6个月的时间内，在ADT上，在250个PC中，将ILIVE与UC在肥胖的脆弱性上进行比较。次要目标是：a）比较iLive对UC对次级结果的影响，例如，个体脆弱的标准，饮食质量，身体功能，生活质量； b）通过比较12个月的组来评估iLive对UC的耐用性随访；和C）探索与干预效果相关的潜在主持人（例如年龄，种族，BMI）。最后，我们的三级目标是：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中的研究。 ilive建立在固体上具有可靠疗效的癌症幸存者的饮食和运动干预措施的基础，拟议的I型混合有效性实施试验旨在加快效率测试和优化，并最终，全国一百万台旧的PC可以降低发病率和死亡率。