Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients being approached that agree to participate in the study [12 months]
Measure 1 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 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 for whom all data is successfully recorded within the database [12 months]
Measure 5 for study feasibility
Secondary Outcome Measures
- VO2max measured both pre- and post-chemotherapy [12 months]
Measured via cycle egometry
- 6 Minute Walk Distance (6MWD) [12 months]
- Patient-reported sympotomatic toxicity and quality of life [12 months]
Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment
- 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
- Clinician-rated performance status [12 months]
Clinician-rated ECOG and Karnofsky Performance Status (KPS)
- Incidence and number of falls [12 months]
Measured by HealthPatch
- Sleep duration [12 months]
Measured by Philips Actiwatch
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
-
Age ≥ 18, prioritizing patients ≥ 60 years
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At least 6 weeks out from surgical resection
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Presence of working email address
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Access to internet at home and either access to wireless internet or cellular data reception
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Ability to read and understand English
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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
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Contraindication to CPET per standard American Thoracic Society (ATS) guidelines
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27514 |
Sponsors and Collaborators
- UNC Lineberger Comprehensive Cancer Center
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- LCCC 1605