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

NCT02786628 | Completed DMC

• 1 other identifier: LCCC 1543
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumour; Hematologic Malignancies; Planned Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (4)

• Proportion of patients being approached that agree to participate in the study

  This is measure 1 for determining study feasibility

  7 months

• 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

• Proportion of recruited patients who wear Fitbit for at least 8 hours per day

  This is measure 3 for determining study feasibility

  7 months

• 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 Outcomes (6)

• Compare pre-treatment aerobic capacity (VO2max or 6MWD) with post-treatment average measured steps per day

  7 months

• Compare pre-treatment clinician-rated performance status and aerobic capacity (VO2max or 6MWD) with post-treatment average steps per day

  7 months

• 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

• Compare average measured steps per day and patient-reported symptomatic toxicities

  7 months

• Compare resting heart rate trajectories (as measured by Fitbit) before and after chemotherapy

  7 months

Study Arms (3)

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

Hematologic malignancies

15 patients. Will participate in physical performance testing and patient-generated health data.

Other: Physical performance testing and patient-generated health data

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

Interventions

Physical performance testing and patient-generated health data OTHER

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; Hematopoietic cell transplantation; Solid tumor malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Wood WA, Dilip D, Derkach A, Grover NS, Elemento O, Levine R, Thanarajasingam G, Batsis JA, Bailey C, Kannappan A, Devine SM, Artz AS, Ligibel JA, Basch E, Kent E, Glass J. Wearable sensor-based performance status assessment in cancer: A pilot multicenter study from the Alliance for Clinical Trials in Oncology (A19_Pilot2). PLOS Digit Health. 2023 Jan 26;2(1):e0000178. doi: 10.1371/journal.pdig.0000178. eCollection 2023 Jan.

  PMID: 36812616 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Exercise Test; Patient Generated Health Data

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods

Study Officials

• Natalie Grover, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• William A Wood, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (1)