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

Completed

• Conditions: Malignant Solid Tumor; Hematologic Malignancies
• Interventions: Device: Biometric Devices; Other: Physical Performance Testing

• Registration Number: NCT02844400
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Study Start: 2016-11
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Palliative Chemoteraphy	Biometric Devices	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.
Adjuvant and Curative Chemotherapy	Biometric Devices	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.
Adjuvant and Curative Chemotherapy	Physical Performance Testing	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.
Palliative Chemoteraphy	Physical Performance Testing	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States