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



Status:Completed
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:November 2016
End Date:December 2018

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

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.

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.

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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Phone: 919-962-5423
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from
Chapel Hill, NC
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