Core 3: Assessment and Analysis Shared Resource Core

核心3：评估与分析共享资源核心

基本信息

批准号：
10247790
负责人：
MARIA PISU
金额：
$ 58.69万
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/10247790
关键词：
Accelerometer Aging Alabama Algorithms Behavior Behavior Therapy Behavioral Biological Biological Markers Biometry Blood Body Composition Cancer Survivor Cancer Survivorship Cataloging Characteristics Collaborations Collection Complex Comprehensive Cancer Center Consent Consultations Cost Effectiveness Analysis Cost Savings Data Data Collection Data Store Dissemination and Implementation Doctor of Philosophy Environment Equation Fostering Goals Health Health Care Costs Home visitation Human Resources Inflammation International Intervention Knowledge Label Laboratories Life Style Link Malignant Neoplasms Mediator of activation protein Methodology Minority Modeling Monitor Nurses Outcome Participant Physical Function Physical Performance Population Positioning Attribute Procedures Process Quality Control Quality of life Quality-Adjusted Life Years Questionnaires Randomized Research Research Design Research Personnel Resource Sharing Resources Rural Rural Minority Sampling Savings Science Secure Self Administration Services Shipping Societies Statistical Data Interpretation Structure Subgroup Surveys Survivors System Telephone Testing Training Treatment Efficacy Universities Urine Waiting Lists Work adjudicate arm central database cost cost effectiveness data management data quality data sharing effectiveness evaluation efficacy testing experience immune function implementation cost implementation intervention improved improved outcome neoplasm registry primary outcome recruit research study sample collection screening secondary outcome study population underserved minority

项目摘要

The primary objective of the AMPLIFI Assessment and Analysis (AA) Shared Resource Core (SRC) is to support the scientific objectives of all AMPLIFI projects and SRCs through data and biospecimen collection, data management, and statistical and cost-effectiveness analysis. The AA SRC will work in collaboration with and assist the Recruitment and Retention (RR) and Adaptation, Dissemination, and Implementation (ADI) and the Administration (ADMIN) SRCs, and leverage exceptional resources at the University of Alabama at Birmingham. The AA SRC's specific aims are: (1) To implement the AMPLIFI study design. The AA SRC will randomize 652 survivors to the AMPLIFI study arms using block randomization; (2) To facilitate AMPLIFI data collection, entry and management. The AA SRC will enter or download, manage, clean, and link all AMPLIFI data obtained from cancer registries, screening and recruitment process, participants' assessments, and laboratories. A REDCap system will be set up to track data collection materials sent and received. Participants' assessments will consist of self-administered questionnaires, phone surveys, home visits (which include blood and urine sample collection) and accelerometer monitoring. Home visits will be conducted by Examination Management Services Inc. (EMSI), a company with trained nurses used in previous research studies. The AA SRC will process, prepare for statistical analysis, and store data from AMPLIFI projects and ADI and RR SRCs; (3) To plan and conduct statistical analyses for AMPLIFI Projects and Cores. The AA SRC provides expert statistical and methodological consultation to project investigators and SRC leaders by planning and conducting statistical analyses in support of AMPLIFI projects, and additional analyses for the RR and ADI SRCs. This will include testing the efficacy of the AMPLIFI interventions on the primary outcomes, exploring the interventions' impact on secondary outcomes (including quality of life, physical functioning and performance, body composition, and biomarkers of inflammation, immune function, and successful aging), conducting mediator/moderator analyses to ascertain the constructs by which the intervention exerts its effects and the key survivor characteristics that influence intervention efficacy; and (4) To plan and conduct cost- effectiveness analyses of the AMPLIFI interventions. The AA SRC will assess if the tested interventions are economically attractive, i.e., assess how interventions' benefits in terms of quality of life gains compare with their net cost (implementation costs – savings in health care costs, if any). Attainment of these aims will contribute to the wider dissemination of the tested interventions by demonstrating their efficacy and cost- effectiveness, the mechanisms by which they work to impact lifestyle behaviors, and in whom they work best. The outstanding AA SRC team has decades of experience in implementing study designs, performing data collection and management, and conducting statistical and cost-effectiveness analyses. Therefore, it is well positioned to contribute to AMPLIFI goals and to the advancement of cancer survivorship research.

AMPLIFI 评估和分析 (AA) 共享资源核心 (SRC) 的主要目标是通过数据和生物样本收集支持所有 AMPLIFI 项目和 SRC 的科学目标， AA SRC 将与数据管理、统计和成本效益分析合作。协助招募和保留 (RR) 以及适应、传播和实施 (ADI) 以及行政 (ADMIN) SRC，并利用阿拉巴马大学的特殊资源伯明翰 AA SRC 的具体目标是： (1) 实施 AMPLIFI 研究设计。将使用分组随机化将 652 名幸存者随机分配到 AMPLIFI 研究组； (2) 促进 AMPLIFI AA SRC 将输入或下载、管理、清理和链接所有数据。 AMPLIFI 数据来自癌症登记、筛查和招募过程、参与者的评估、将建立 REDCap 系统来跟踪发送和接收的数据收集材料。参与者的评估将包括自填问卷、电话调查、家访（其中包括血液和尿液样本采集）和加速度计监测将由以下人员进行。 Examination Management Services Inc. (EMSI)，一家在之前的研究中使用经过培训的护士的公司 AA SRC 将处理、准备统计分析并存储来自 AMPLIFI 项目和的数据。 ADI 和 RR SRC； (3) 规划并进行 AMPLIFI 项目和核心的统计分析。 SRC 通过以下方式向项目调查人员和 SRC 领导者提供专家统计和方法咨询：规划和进行统计分析以支持 AMPLIFI 项目，以及对 RR 的其他分析这将包括测试 AMPLIFI 干预措施对主要结局的功效，探索干预措施对次要结果的影响（包括生活质量、身体机能和性能、身体成分、炎症生物标志物、免疫功能和成功衰老），进行中介/调节因素分析，以确定干预措施发挥作用的结构以及影响干预效果的关键幸存者特征；以及 (4) 计划和实施成本- AMPLIFI 干预措施的有效性分析 AA SRC 将评估测试的干预措施是否有效。具有经济吸引力，即评估干预措施在生活质量增益方面的益处如何进行比较及其净成本（实施成本——医疗保健成本的节省，如果有的话）。通过展示其有效性和成本，有助于更广泛地传播经过测试的干预措施有效性，即他们影响生活方式行为的机制，以及他们在谁身上发挥最佳作用。杰出的 AA SRC 团队在实施研究设计、执行数据方面拥有数十年的经验收集和管理，并进行统计和成本效益分析，因此很好。旨在为 AMPLIFI 目标和癌症生存研究的进步做出贡献。