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

• ClinicalTrials.gov Identifier: NCT02786628
• Recruitment Status: Completed
• First Posted: June 1, 2016
• Last Update Posted: March 22, 2018
• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Information provided by (Responsible Party): UNC Lineberger Comprehensive Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment
Malignant Solid Tumour; Hematologic Malignancies; Planned Hematopoietic Cell Transplantation	Other: Physical performance testing and patient-generated health data

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessing Physical Fitness in Cancer Patients With Cardiopulmonary Exercise Testing and Wearable Data Generation
• Study Start Date: February 2016
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Solid tumor malignancies; 15 patients. Will participate in physical performance testing and patient-generated health data.	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.
Hematologic malignancies; 15 patients. Will participate in physical performance testing and patient-generated health data.	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.
Hematopoietic cell transplantation; 15 patients. Will participate in physical performance testing and patient-generated health data.	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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients being approached that agree to participate in the study [ Time Frame: 7 months ]
   This is measure 1 for determining study feasibility
2. Proportion of enrolled patients who complete CPET and 6MWD test without significant testing-related adverse events [ Time Frame: 7 months ]
   This is measure 2 for determining study feasibility
3. Proportion of recruited patients who wear Fitbit for at least 8 hours per day [ Time Frame: 7 months ]
   This is measure 3 for determining study feasibility
4. Proportion of patients for whom all data is successfully recorded within database [ Time Frame: 7 months ]
   This is measure 4 for determining study feasibility; using UNC PRO-Core and Fitabase to collect information

Secondary Outcome Measures :

1. Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day [ Time Frame: 7 months ]
   Comparison made to determine if pre-treatment aerobic capacity is predictive of post-treatment steps per day.
2. Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day [ Time Frame: 7 months ]
   Comparison made to determine which pre-treatment value better predicts post-treatment steps per days.
3. 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 ]
4. Compare average measured steps per day and patient-reported symptomatic toxicities [ Time Frame: 7 months ]
5. Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy [ Time Frame: 7 months ]
6. Compare resting heart rates as measured from VO2max testing with resting heart rates as measured by Fitbit [ Time Frame: 7 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

45 patients with cancer undergoing a cycle of cytotoxic chemotherapy or bone marrow transplant.

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

Contacts and Locations

Locations

United States, North Carolina

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27514

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

Investigators

• Principal Investigator: Natalie Grover, MD; University of North Carolina, Chapel Hill
• Principal Investigator: William A Wood, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02786628
• Other Study ID Numbers: LCCC 1543
• First Posted: June 1, 2016
• Last Update Posted: March 22, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Hematologic Neoplasms; Neoplasms; Neoplasms by Site; Hematologic Diseases