Clinical trial NCT02786628: Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
Official title: Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Solid Tumour
Hematologic Malignancies
Planned Hematopoietic Cell Transplantation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 patients with cancer undergoing a cycle of cytotoxic chemotherapy or bone marrow transplant.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with solid tumor or hematologic malignancies who are planning to receive a cycle of cytotoxic chemotherapy or patients who are planning to receive stem cell transplant.
* Age ≥ 18
* At least 6 weeks out from surgical resection
* Presence of working email address
* Access to internet at home and access to electronic device(s) capable of charging and syncing the Fitbit
* Ability to read and understand English
* Ability to understand and comply with study procedures including wearing Fitbit for the entire length of the study
* Approval of attending oncologist for participation in the study
* Hb ≥ 8 g/dL (most recent lab draw)
* Willingness and ability to provide written informed consent

Exclusion Criteria:

* Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
* Presence of cardiac disease including acute MI within past 6 weeks, unstable angina, uncontrolled arrhythmias causing symptoms, active endocarditis, myocarditis, or pericarditis,symptomatic aortic stenosis, uncontrolled heart failure, syncope in the past 6 weeks, severe untreated hypertension at rest (\>180 mmHg systolic, \>100 mmHg diastolic)
* Acute pulmonary embolism or thrombosis of lower extremities in the past 6 weeks
* Uncontrolled asthma
* Pulmonary edema
* Suspected dissecting aneurysm
* Room air desaturation at rest \</= 88%
* Respiratory failure
* Acute noncardiopulmonary disorder that may be aggravated by exercise
* Mental impairment leading to inability to cooperate with instructions
* Orthopedic impairment that compromises exercise performance

Primary outcomes:
measure: Proportion of patients being approached that agree to participate in the study
timeFrame: 7 months
measure: Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events
timeFrame: 7 months
measure: Proportion of recruited patients who wear Fitbit for at least 8 hours per day
timeFrame: 7 months
measure: Proportion of patients for whom all data is successfully recorded within database
timeFrame: 7 months
Secondary outcomes:
measure: Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day
timeFrame: 7 months
measure: Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day
timeFrame: 7 months
measure: 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)
timeFrame: 7 months
measure: Compare average measured steps per day and patient-reported symptomatic toxicities
timeFrame: 7 months
measure: Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy
timeFrame: 7 months
measure: Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit
timeFrame: 7 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Natalie Grover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: William A Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: