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IN4M: Physical Function & Cancer

The IN4M Study: Quantifying physical function in cancer patients undergoing chemotherapy using clinician- and patient- reports along with wearable device data

This study aims to understand the measurement characteristics and relationships among various physical function assessments and activity data collected from a wearable device in cancer patients undergoing chemotherapy. The goals of the research are to: (1) collect data on physical function using clinician- and patient-reported methods, performance measurement, and wearable devices; (2) compare the challenges associated with collecting information using each physical function assessment tool; (3) compare longitudinal changes in physical function with the likelihood and magnitude of side effects from chemotherapy; and (4) conduct a structured exit interview to evaluate burden and usability across the different physical function evaluation modalities and a wearable device. The ultimate goal of this project is to provide evidence and knowledge to guide the selection of PF assessment modality/tool(s) to be incorporated in cancer clinical trials as an endpoint for regulatory and treatment decisions.

Funding source: U.S. Food and Drug Administration

Principal Investigator: Cary Gross