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.

Public Health Relevance

ASSESSMENT AND ANALYSIS SHARED RESOURCE CORE PROJECT NARRATIVE The Assessment and Analysis (AA) Shared Resource Core (SRC) will: 1) orchestrate biospecimen collection and analysis; 2) facilitate data entry, collection, and management; 3) plan and conduct statistical analyses for all projects and SRCs; and 4) plan and conduct cost-effectiveness analyses of the interventions. By achieving its aims, the AA SRC will demonstrate the efficacy and cost-effectiveness of the proposed interventions and explore the mechanisms by which interventions influence health outcomes and behaviors, and in whom they work best. Given the AMPLIFI study population, the AA SRC will have a significant impact on the science of improving the lives of cancer survivors, especially of those who are older, rural and underserved minorities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
5P01CA229997-02
Application #
9771431
Study Section
Special Emphasis Panel (ZCA1)
Project Start
Project End
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294