The primary objective of this study is to assess the feasibility of a multi-institutional study that collects cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant), followed by collection of patient generated health data (wearable activity monitors and patient reported outcomes) for the subsequent month. In addition to demonstrating feasibility, the study looks to generate preliminary data that supports the capacity of physical performance testing and patient-generated health data to complement clinician-rated performance status in patients receiving chemotherapy.
Physical fitness, based on tests of physical performance and measurements of daily activity, can serve as both a risk stratification variable and clinical outcome for patients prior to or during cytotoxic chemotherapy. Many cytotoxic therapies cause premature aging and frailty in a sizable portion of patients, so measuring and improving physical function may also limit late morbidity and mortality in certain patient populations. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) in addition to organ-specific function have been used to prognosticate risk and determine treatment strategy, but cPS only readily identifies individuals with significant functional compromise. Objective evaluations of physical function, such as aerobic capacity and measured daily activity, may have greater potential to improve the precision of performance status evaluation.
Study Type
OBSERVATIONAL
Enrollment
43
All patients will complete cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant) and wear a Fitbit Charge HR for the duration of one cycle of chemotherapy.
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Proportion of patients being approached that agree to participate in the study
This is measure 1 for determining study feasibility
Time frame: 7 months
Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events
This is measure 2 for determining study feasibility
Time frame: 7 months
Proportion of recruited patients who wear Fitbit for at least 8 hours per day
This is measure 3 for determining study feasibility
Time frame: 7 months
Proportion of patients for whom all data is successfully recorded within database
This is measure 4 for determining study feasibility; using UNC PRO-Core and Fitabase to collect information
Time frame: 7 months
Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day
Comparison made to determine if pre-treatment aerobic capacity is predictive of post-treatment steps per day.
Time frame: 7 months
Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day
Comparison made to determine which pre-treatment value better predicts post-treatment steps per days.
Time frame: 7 months
Compare pre-treatment aerobic capacity (VO2max or 6MWD) and post-treatment average measured steps per day among the three cohorts (solid tumor, hematologic malignancies, hematopoietic cell transplantation)
Time frame: 7 months
Compare average measured steps per day and patient-reported symptomatic toxicities
Time frame: 7 months
Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy
Time frame: 7 months
Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit
Time frame: 7 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.