Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation

Completed

Conditions studied: Malignant Solid Tumour, Hematologic Malignancies, Planned Hematopoietic Cell Transplantation

In brief

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.

Key facts

Study ID

NCT02786628

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

43

Starts

2016-02-01

Expected to finish

2018-02-01

Last updated by the study team

2018-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.