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

NCT02844400 | Completed DMC

• 1 other identifier: LCCC 1605
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Solid Tumor; Hematologic Malignancies

Outcome Measures

Primary Outcomes (5)

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

  Measure 1 for study feasibility

  12 months

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

  Measure 2 for study feasibility

  12 months

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

  Measure 3 for study feasibility

  12 months

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

  Measure 4 for study feasibility

  12 months

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

  Measure 5 for study feasibility

  12 months

Secondary Outcomes (8)

• VO2max measured both pre- and post-chemotherapy

  12 months

• 6 Minute Walk Distance (6MWD)

  12 months

• Patient-reported sympotomatic toxicity and quality of life

  12 months

• Patient activity/steps per day

  12 months

• Heart rate

  12 months

Study Arms (2)

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.

Device: Biometric Devices; Other: Physical Performance Testing

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.

Device: Biometric Devices; Other: Physical Performance Testing

Interventions

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.

Adjuvant and Curative Chemotherapy; Palliative Chemoteraphy

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.

Adjuvant and Curative Chemotherapy; Palliative Chemoteraphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients with cancer undergoing a cycle of cytotoxic chemotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Natalie Grover, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• William A Wood, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 26, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

US (1)