Hematologic Malignancies, Malignant Solid Tumor
Conditions
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.
Interventions
DEVICEBiometric 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.
OTHERPhysical 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.
Sponsors
Genentech, Inc.
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients being approached that agree to participate in the study | 12 months | Measure 1 for study feasibility |
| Proportion of patients who complete both baseline and follow up CPET tests without significant testing-related adverse events | 12 months | Measure 2 for study feasibility |
| Proportion of patients who wear HealthPatch and have data captured successfully for at least 75% of the time | 12 months | Measure 3 for study feasibility |
| Patients who wear Philips Actiwatch and have data captured successfully for at least 75% of the time | 12 months | Measure 4 for study feasibility |
| Proportion of patients for whom all data is successfully recorded within the database | 12 months | Measure 5 for study feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-rated performance status | 12 months | Clinician-rated ECOG and Karnofsky Performance Status (KPS) |
| VO2max measured both pre- and post-chemotherapy | 12 months | Measured via cycle egometry |
| Sleep duration | 12 months | Measured by Philips Actiwatch |
| Incidence and number of falls | 12 months | Measured by HealthPatch |
| 6 Minute Walk Distance (6MWD) | 12 months | — |
| Patient-reported sympotomatic toxicity and quality of life | 12 months | Measured using PROMIS, PRO-CTCAE, Godin Leisure Time Exercise questionnaires and Geriatric Assessment |
| Patient activity/steps per day | 12 months | Measured using Philips Actiwatch |
| Heart rate | 12 months | Continuous heart rate data, resting heart rate, and heart rate variability will be measured using HealthPatch |
Countries
United States
Outcome results
None listed