The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.
Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.
Study Type
OBSERVATIONAL
Enrollment
67
Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.
Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Proportion of patients being approached that agree to participate in the study
Measure 1 for study feasibility
Time frame: 12 months
Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events
Measure 2 for study feasibility
Time frame: 12 months
Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time
Measure 3 for study feasibility
Time frame: 12 months
Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time
Measure 4 for study feasibility
Time frame: 12 months
Proportion of patients for whom all data is successfully recorded within the database
Measure 5 for study feasibility
Time frame: 12 months
VO2max measured both pre- and post-chemotherapy
Measured via cycle egometry
Time frame: 12 months
6 Minute Walk Distance (6MWD)
Time frame: 12 months
Patient-reported sympotomatic toxicity and quality of life
Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment
Time frame: 12 months
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Patient activity/steps per day
Measured using Philips Actiwatch
Time frame: 12 months
Heart rate
Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch
Time frame: 12 months
Clinician-rated performance status
Clinician-rated ECOG and Karnofsky Performance Status (KPS)
Time frame: 12 months
Incidence and number of falls
Measured by HealthPatch
Time frame: 12 months
Sleep duration
Measured by Philips Actiwatch
Time frame: 12 months