Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation

Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study

The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancies; Malignant Solid Tumor
• Intervention / Treatment: Device: Biometric Devices; Other: Physical Performance Testing

Detailed Description

Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients with cancer undergoing a cycle of cytotoxic chemotherapy.

Description

Inclusion Criteria:

• Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
• Age ≥ 18, prioritizing patients ≥ 60 years
• At least 6 weeks out from surgical resection
• Presence of working email address
• Access to internet at home and either access to wireless internet or cellular data reception
• Ability to read and understand English
• Ability to understand and comply with study procedures

Exclusion Criteria:

• Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
• Contraindication to CPET per standard American Thoracic Society (ATS) guidelines

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adjuvant and Curative Chemotherapy; 30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with adjuvant or curative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions.	Device: Biometric Devices; Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.; Other: Physical Performance Testing; Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.
Palliative Chemoteraphy; 30 participants. Primarily older (60+ years in age) cancer patients receiving cytotoxic chemotherapy with palliative intent. Will undergo both the Physical Performance Testing and Biometric Devices interventions.	Device: Biometric Devices; Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.; Other: Physical Performance Testing; Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients being approached that agree to participate in the study	Measure 1 for study feasibility	12 months
Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events	Measure 2 for study feasibility	12 months
Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time	Measure 3 for study feasibility	12 months
Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time	Measure 4 for study feasibility	12 months
Proportion of patients for whom all data is successfully recorded within the database	Measure 5 for study feasibility	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2max measured both pre- and post-chemotherapy	Measured via cycle egometry	12 months
6 Minute Walk Distance (6MWD)		12 months
Patient-reported sympotomatic toxicity and quality of life	Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment	12 months
Patient activity/steps per day	Measured using Philips Actiwatch	12 months
Heart rate	Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch	12 months
Clinician-rated performance status	Clinician-rated ECOG and Karnofsky Performance Status (KPS)	12 months
Incidence and number of falls	Measured by HealthPatch	12 months
Sleep duration	Measured by Philips Actiwatch	12 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Natalie Grover, MD, University of North Carolina, Chapel Hill; Principal Investigator: William A Wood, MD, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: LCCC 1605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED