Core 3: Assessment and Analysis Shared Resource Core

NIH RePORTER · NIH · P01 · $1,019,647 · view on reporter.nih.gov ↗

Abstract

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 managemen...

Key facts

NIH application ID
10480010
Project number
5P01CA229997-05
Recipient
UNIVERSITY OF ALABAMA AT BIRMINGHAM
Principal Investigator
MARIA PISU
Activity code
P01
Funding institute
NIH
Fiscal year
2022
Award amount
$1,019,647
Award type
5
Project period
2018-09-01 → 2024-08-31