Clinical trial NCT02844400: Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation
Official title: Assessing Performance Status in Cancer Patients Using Cardiopulmonary Exercise Testing and Wearable Data Generation: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Solid Tumor
Hematologic Malignancies
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2016-07-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients with cancer undergoing a cycle of cytotoxic chemotherapy.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Proportion of patients being approached that agree to participate in the study
timeFrame: 12 months
measure: Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events
timeFrame: 12 months
measure: Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time
timeFrame: 12 months
measure: Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time
timeFrame: 12 months
measure: Proportion of patients for whom all data is successfully recorded within the database
timeFrame: 12 months
Secondary outcomes:
measure: VO2max measured both pre- and post-chemotherapy
timeFrame: 12 months
measure: 6 Minute Walk Distance (6MWD)
timeFrame: 12 months
measure: Patient-reported sympotomatic toxicity and quality of life
timeFrame: 12 months
measure: Patient activity/steps per day
timeFrame: 12 months
measure: Heart rate
timeFrame: 12 months
measure: Clinician-rated performance status
timeFrame: 12 months
measure: Incidence and number of falls
timeFrame: 12 months
measure: Sleep duration
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Natalie Grover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: William A Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: