Project 3: Simultaneous Combined Or Sequential (S.O.S.) Approaches to Behavior Change for Survivors

项目 3：同时组合或顺序 (S.O.S.) 方法改变幸存者的行为

基本信息

批准号：
10247782
负责人：
Dorothy W. Pekmezi
金额：
$ 27.76万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10247782
关键词：
Accelerometer Address Adult Aerobic Age Aging Area Attention Behavior Behavior Therapy Behavioral Behavioral Sciences Biological Markers Body Weight decreased Cancer Survivor Chronic Disease Clinical Consensus Diet Dissemination and Implementation Dropout Education Educational Intervention Exercise General Population Goals Health Health behavior Health behavior change Health behavior outcomes Healthcare Systems Income Individual Inflammation Intervention Intervention Studies Lead Life Style Maintenance Malignant Neoplasms Measures Mediation Mediator of activation protein Minority Minority Groups National Cancer Institute Nature Older Population Outcome Participant Patient Self-Report Physical Function Physical activity Population Populations at Risk Prevalence Process Public Health Quality of life Quality-Adjusted Life Years Race Randomized Randomized Controlled Trials Research Risk Risk Behaviors Risk Factors Rural Rural Minority Rural Population Sampling Second Primary Cancers Self Efficacy Societies Subgroup Survivors Target Populations Technology Testing Time Treatment Efficacy Underserved Population Unhealthy Diet Weight arm base behavior change burden of illness cancer recurrence cancer risk comorbidity cost cost effective cost-effectiveness evaluation efficacy testing experience functional decline health care service utilization healthy lifestyle high risk immune function immunological status improved interest intervention cost lean body mass meetings modifiable risk patient population physical inactivity post intervention programs randomized controlled design randomized trial rural underserved secondary outcome social cognitive theory success systematic review systemic inflammatory response theories treatment arm web-based intervention

项目摘要

Health risks (poor diet, excess weight, physical inactivity) in rising numbers of cancer survivors represent a substantial public health concern and can lead to second primaries and cancer recurrence, as well as other comorbidities and functional decline. Effective behavioral interventions are needed for this population. Studies to date have largely addressed individual lifestyle behaviors as independent factors, but there often are multiple health risks that require attention amongst survivors. Thus, intervening upon multiple modifiable risk factors is much more likely to impact public health than intervening on a single behavior. Multiple behavior change interventions have shown success in the general population, as well as promising results in the few available studies in cancer survivors. However, several gaps in this research remain. First, there is no consensus on the best approach to multiple behavior change and the few studies that have compared simultaneous vs. sequential multiple behavior interventions yielded mixed findings. Clarifying best practices for multiple behavior change has important clinical implications and will be key to moving the field forward. Second, this line of research has yet to be fully extended to at risk populations. As noted, there have been some multiple behavior change studies conducted in cancer survivors, but none have examined simultaneous vs. sequential intervention approaches and most involved predominantly younger, well-educated White samples. The National Cancer Institute has called for multiple behavior change research in underserved populations, i.e., survivors of various cancers who also are rural, older and minority. Thus, the proposed Project 3, which builds upon Projects 1-2 of AMPLIFI, will test the efficacy of simultaneous vs. sequential interventions targeting diet, weight loss, and/or exercise, and explore which combination or order is best to maximize change for cancer survivors. The study will use a randomized controlled design with 652 cancer survivors from mostly older, rural, and minority groups. Primary aims include determining the relative efficacy of two approaches (simultaneous vs. sequenced) to multiple health behavior change, with meeting behavioral goals (improved diet quality, 3% weight loss, ≥150 weekly minutes of ≥moderate intensity physical activity) post-intervention as endpoints of interest. Secondary aims include examining maintenance of gains at 6 months post-intervention and arm differences in physical activity and function, lean body mass, quality of life, and biomarkers of successful aging, immune status, and systemic inflammation; identifying potential mediators (SCT constructs) and moderators (education) of intervention efficacy; and evaluating the cost-effectiveness of sequenced vs. simultaneous technology-based interventions. This will be one of the largest trials ever to compare sequential vs. simultaneous interventions. Findings will be of high public health impact given the diversity and high risk nature of the patient population.

越来越多的癌症幸存者面临健康风险（不良饮食、超重、缺乏身体活动）重大公共卫生问题，可能导致第二次初选和癌症复发以及其他该人群需要进行有效的行为干预研究。迄今为止，人们在很大程度上将个人生活方式行为视为独立因素，但往往存在需要幸存者关注的多种健康风险，因此，对多种可改变的风险进行干预。多个因素比干预单一行为更有可能影响公共健康。变革干预措施在普通民众中取得了成功，在少数人中也取得了有希望的结果然而，这项研究仍然存在一些空白。关于多种行为改变的最佳方法的共识以及进行比较的少数研究同时与连续的多种行为干预得出了不同的结果。多种行为改变具有重要的临床意义，并将成为该领域前进的关键。其次，这一研究领域尚未完全扩展到高危人群。对癌症幸存者进行了一些多项行为改变研究，但没有同时进行检查与序贯干预方法相比，大多数涉及年轻、受过良好教育的白人美国国家癌症研究所呼吁对服务不足的地区进行多项行为改变研究。人口，即各种癌症的幸存者，他们也是农村人口、老年人和少数民族。项目 3 以 AMPLIFI 项目 1-2 为基础，将测试同时与顺序的功效针对饮食、减肥和/或运动的干预措施，并探索哪种组合或顺序最适合该研究将采用随机对照设计，对 652 名癌症患者进行最大程度的改变。主要目标包括确定相对功效。两种方法（同时与顺序）来改变多种健康行为，并满足行为目标（改善饮食质量、体重减轻 3%、每周 ≥150 分钟≥中等强度的体力活动）干预后作为感兴趣的终点包括检查 6 的增益维持情况。干预后几个月和手臂在身体活动和功能、去脂体重、生活质量方面的差异，以及成功衰老、免疫状态和全身炎症的生物标志物；识别潜在的介质；干预效果的（SCT 构建）和调节因素（教育）并评估成本效益；顺序干预与同时基于技术的干预措施这将是有史以来最大规模的试验之一。鉴于以下情况，比较顺序干预与同时干预的结果将对公共卫生产生重大影响。患者群体的多样性和高风险性。