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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Malignant Solid Tumor; Hematologic Malignancies

Treatments: Other: Physical Performance Testing; Device: Biometric Devices

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02844400

LCCC 1605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

67 participants in 2 patient groups

Adjuvant and Curative Chemotherapy

Description:

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.

Treatment:

Other: Physical Performance Testing

Device: Biometric Devices

Palliative Chemoteraphy

Description:

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.

Treatment:

Other: Physical Performance Testing

Device: Biometric Devices