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

NCT ID: NCT02786628

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-02-28

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.

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.

Conditions

Malignant Solid Tumour; Hematologic Malignancies; Planned Hematopoietic Cell Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Solid tumor malignancies

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

Physical performance testing and patient-generated health data

Intervention Type: 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

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

Physical performance testing and patient-generated health data

Intervention Type: 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.

Hematopoietic cell transplantation

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

Physical performance testing and patient-generated health data

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Grover, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

William A Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36812616 (View on PubMed)

Other Identifiers

LCCC 1543

Identifier Type: -

Identifier Source: org_study_id