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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786628
• Other study ID #: LCCC 1543
• Status: Completed
• First received: May 23, 2016
• Last updated: March 21, 2018
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Malignant Solid Tumour
• Planned Hematopoietic Cell Transplantation

Intervention

Other:
• Physical performance testing and patient-generated health data
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.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients being approached that agree to participate in the study	This is measure 1 for determining study feasibility	7 months
Primary	Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events	This is measure 2 for determining study feasibility	7 months
Primary	Proportion of recruited patients who wear Fitbit for at least 8 hours per day	This is measure 3 for determining study feasibility	7 months
Primary	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	7 months
Secondary	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.	7 months
Secondary	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.	7 months
Secondary	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)		7 months
Secondary	Compare average measured steps per day and patient-reported symptomatic toxicities		7 months
Secondary	Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy		7 months
Secondary	Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit		7 months