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

• 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
• 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

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.

健康风险（不良饮食，超重，缺乏身体活动）在越来越多的癌症幸存者代表了一个 严重公共卫生问题，并可能导致第二原发性和癌症复发，以及其他 合并症和功能下降。需要对这一人群进行有效的行为干预。研究 到目前为止，人们在很大程度上把个人的生活方式行为作为独立的因素来处理，但往往 需要幸存者注意的多种健康风险。因此，干预多种可改变的风险 影响公共健康的因素比干预单一行为更有可能。多个行为 变革干预措施在一般人群中取得了成功，在少数人中也取得了可喜的成果。 在癌症幸存者中的可用研究。然而，在这项研究中仍然存在一些差距。一是没有 关于多种行为改变的最佳方法的共识，以及比较 同时与顺序的多行为干预产生了混合的结果。澄清以下方面的最佳做法 多重行为改变具有重要的临床意义，并将是推动该领域向前发展的关键。 其次，这一研究方向尚未完全扩展到高危人群。如前所述， 在癌症幸存者中进行了一些多项行为改变研究，但没有一项研究同时 vs.序贯干预方法，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地区进行多种行为改变研究。 人口，即，各种癌症的幸存者，他们也是农村人、老年人和少数民族。因此，拟议的 项目3以AMPLIFI项目1-2为基础，将测试同时与顺序的效果 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 为癌症幸存者带来最大的改变。该研究将采用随机对照设计， 幸存者大多来自老年人、农村和少数群体。主要目的包括确定相对功效 多种健康行为改变的两种方法（同时与顺序）， 目标（改善饮食质量，体重减轻3%，每周≥150分钟的≥中等强度体力活动） 干预后作为关注的终点。次要目标包括研究在6 干预后10个月和手臂在身体活动和功能，瘦体重，生活质量， 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 (SCT结构）和调节（教育）的干预效果;和评估的成本效益 有序与同步的技术干预。这将是有史以来最大的审判之一， 比较顺序干预与同时干预。调查结果将对公共卫生产生重大影响， 患者人群的多样性和高风险性。