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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844400
• Other study ID #: LCCC 1605
• Status: Completed
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Malignant Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients being approached that agree to participate in the study	Measure 1 for study feasibility	12 months
Primary	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
Primary	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
Primary	Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time	Measure 4 for study feasibility	12 months
Primary	Proportion of patients for whom all data is successfully recorded within the database	Measure 5 for study feasibility	12 months
Secondary	VO2max measured both pre- and post-chemotherapy	Measured via cycle egometry	12 months
Secondary	6 Minute Walk Distance (6MWD)		12 months
Secondary	Patient-reported sympotomatic toxicity and quality of life	Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment	12 months
Secondary	Patient activity/steps per day	Measured using Philips Actiwatch	12 months
Secondary	Heart rate	Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch	12 months
Secondary	Clinician-rated performance status	Clinician-rated ECOG and Karnofsky Performance Status (KPS)	12 months
Secondary	Incidence and number of falls	Measured by HealthPatch	12 months
Secondary	Sleep duration	Measured by Philips Actiwatch	12 months

External Links

•   UNC Lineberger Comprehensive Cancer Center