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  1. Advancing Regulatory Science

Quantifying physical function in cancer patients undergoing chemotherapy using clinician-reported, patient-reported, and wearable device data sources

CERSI Collaborators: Amylou Dueck, PhD (Mayo Clinic), Cary Gross, MD (Yale), Scott Huntington, MD (Yale), Molly Jeffery, PhD (Mayo Clinic), Julianne Lunde, MA (Mayo Clinic), Sarah Mougalian, MD (Yale), Jonas Paludo, MD (Mayo Clinic), Joseph Ross, MD, MHS (Yale), Kathryn Ruddy, MD (Mayo Clinic), Nilay Shah, PhD (formerly at Mayo Clinic, now at Delta Airlines), Gita Thanarajasingam, MD (Mayo Clinic) (PI)

FDA Collaborators: Vishal Bhatnagar, MD, Erica Horodniceanu, MPH, Paul Kluetz, MD, Elizabeth Kunkoski, MS, Leonard Sacks, MD, Michelle Tarver, MD, PhD, Matt Diamond, MD, PhD

Project Start Date: October 2020

Regulatory Science Challenge

Physical function (PF), defined as the ability to carry out day-to-day activities that require physical effort, has been highlighted by cancer patients as an important and meaningful outcome. It is usually measured in cancer clinical trials when clinicians ask how much of the day a patient spends in bed or a chair (also known as performance status).

The FDA Oncology Center of Excellence has identified PF (in addition to cancer-related symptoms and adverse events) as a core clinical outcome to be assessed in cancer clinical trials. Besides assessment of performance status by clinicians, there are other ways of measuring PF including surveys completed by patients, timing how far patients walk in six minutes, and using wearable devices that measure patient step count and other aspects of PF. An optimal approach to the measurement of PF has yet to be defined, as studies directly comparing or integrating multiple methods to assess PF are lacking. Cancer therapy can impact PF, and evaluating PF throughout the course of a cancer treatment may play an important complementary role in informing the tolerability of drugs or regimens used to treat cancer. In order to advance the use of PF as an appropriate endpoint for regulatory and clinical decision-making, a prospective observational study evaluating PF in cancer patients undergoing cancer treatment is needed.

Project Description and Goals

This study aims to understand the measurement characteristics and relationships among various PF 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 PF using clinician- and patient-reported methods, performance measurement, and wearable devices; (2) compare the challenges associated with collecting information using each PF assessment tool; (3) compare longitudinal changes in PF 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 PF 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.

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