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

NCT ID: NCT02844400

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Malignant Solid Tumor; Hematologic Malignancies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Biometric Devices

Intervention Type: 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

Intervention Type: 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.

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.

Biometric Devices

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Grover, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

William A Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

LCCC 1605

Identifier Type: -

Identifier Source: org_study_id