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

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786628


Locations
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United States, North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Natalie Grover, MD University of North Carolina, Chapel Hill
Principal Investigator: William A Wood, MD University of North Carolina, Chapel Hill
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02786628    
Other Study ID Numbers: LCCC 1543
First Posted: June 1, 2016    Key Record Dates
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:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases