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

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

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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.

癌症生存数量增加的健康风险（饮食不良，超过体重，身体不活跃）代表广泛的公共卫生问题，可能导致第二个初级和癌症复发，以及其他合并症和功能下降。该人群需要有效的行为干预措施。研究迄今为止多种健康风险需要生存之间的关注。这是干预多个可修改风险的与介入单一行为相比，因素更有可能影响公共卫生。多重行为变更干预措施在一般人群中表现出成功，并承诺导致少数可用的癌症存活研究。但是，这项研究的几个差距仍然存在。首先，没有就多种行为改变的最佳方法达成共识，而少数比较的研究同时与顺序多重行为干预措施产生了混合发现。澄清最佳实践多重行为改变具有重要的临床意义，将是向前推动领域的关键。其次，这一研究尚未完全扩展到风险人群。如前所述，有在癌症存活中进行的一些多重行为改变研究，但没有人同时检查与顺序干预方法，大多数主要涉及年轻，受过良好教育的白色样品。国家癌症研究所呼吁在服务不足的情况下进行多次行为改变研究种群，即也是艰难，年长和少数群体的各种癌症的生存。那，提议基于Amplifi项目1-2的项目3将测试同时效率与顺序的效率针对饮食，减肥和/或运动的干预措施，并探索哪种组合或顺序最适合最大化癌症存活的变化。该研究将使用652个癌症的随机控制设计大多数年龄较大，粗糙和少数群体的幸存者。主要目的包括确定相对效率通过两种方法（同时与测序）进行多种健康行为的改变目标（饮食质量提高，体重减轻3％，每周≥150分钟≥150分钟的强度体育锻炼）干预后作为感兴趣的终点。次要目的包括检查6个收益的维护干预后的月份和手臂在体育锻炼和功能上的差异，瘦体重，生活质量，以及成功衰老，免疫状态和系统性炎症的生物标志物；识别潜在的介体（SCT结构）和主持人（教育）干预效率；并评估测序与同时基于技术的干预措施。这将是有史以来最大的试验之一比较顺序与同时干预措施。鉴于患者人群的多样性和高风险性质。