This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology. The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision. For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
81
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
Boston Medical Center
Boston, Massachusetts, United States
PointCheck's Usability
To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.
Time frame: Up to two-weeks
System Usability Scale (0-100 higher scores indicates better usability)
To confirm the usability of the system using the System Usability Scale
Time frame: Up to three-weeks
PointCheck's Precision
To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.
Time frame: Up to two-weeks
PointCheck's Accuracy
To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and \>500 absolute neutrophil count/µL.
Time frame: Up to three-weeks
PointCheck's Utility
To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.
Time frame: Up to three-weeks
Number of participants with device-related adverse events as assessed by CTCAE v5.0
To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
Time frame: Up to three-weeks
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