208
Participants
Start Date
January 27, 2022
Primary Completion Date
August 22, 2024
Study Completion Date
October 24, 2024
PRO Instruments assessment questionnaire
"Patient Reported Outcome (PRO) questionnaire consisting of:~* PRO-CTCAE (approximately 11 questions plus free text)~* Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short form (version 8c) (8 questions)~* PRO ECOG question (1 question)~* EORTC Quality of Life questionnaire (QLQ)-F17 questions (17 questions)~* Functional Assessment of Cancer Therapy-General version, rated on a 5-point Likert scale, (FACT-GP5) (single item global side effect bother question) (1 question)~* The Patient Global Impression (PGI)-C and PGI-S items (anchors for physical function) (2 questions)"
Baseline Survey Clinician- reported (ClinRO) ECOG
Baseline Survey completed prior to initiation of chemotherapy
Fitbit
wearable device
"Hugo Health (Hugo)"
an electronic platform that aggregates real world EHR data with patient's wearable and PRO data
6 Minute Walk Test (6MWT)
A comprehensive performance measure of exercise capacity, encompassing components of mobility, endurance, and functional capacity measure (PerfO)
Mayo Clinic, Rochester
Yale Cancer Center, New Haven
Food and Drug Administration (FDA)
FED
Yale University
OTHER