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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疗法（ADT）来预防前列腺癌