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Completed

NCT Number: NCT02844400

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biometric Devices

Device

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.

Physical Performance Testing

Other

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.

Primary outcomes

  1. Proportion of patients being approached that agree to participate in the study

    Time frame: 12 months

    Measure 1 for study feasibility

  2. Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events

    Time frame: 12 months

    Measure 2 for study feasibility

  3. Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time

    Time frame: 12 months

    Measure 3 for study feasibility

  4. Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time

    Time frame: 12 months

    Measure 4 for study feasibility

  5. Proportion of patients for whom all data is successfully recorded within the database

    Time frame: 12 months

    Measure 5 for study feasibility

Secondary outcomes

  1. VO2max measured both pre- and post-chemotherapy

    Time frame: 12 months

    Measured via cycle egometry

  2. 6 Minute Walk Distance (6MWD)

    Time frame: 12 months

  3. Patient-reported sympotomatic toxicity and quality of life

    Time frame: 12 months

    Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment

  4. Patient activity/steps per day

    Time frame: 12 months

    Measured using Philips Actiwatch

  5. Heart rate

    Time frame: 12 months

    Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch

  6. Clinician-rated performance status

    Time frame: 12 months

    Clinician-rated ECOG and Karnofsky Performance Status (KPS)

  7. Incidence and number of falls

    Time frame: 12 months

    Measured by HealthPatch

  8. Sleep duration

    Time frame: 12 months

    Measured by Philips Actiwatch

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2016
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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