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 60 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
OBSERVATIONAL
Enrollment
94
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
Hospital Universitari Dexeus. Grupo Quirónsalud
Barcelona, Spain
Breast Unit. Oncology Department. 12 Octubre Hospital
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
PointCheck's Usability
To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.
Time frame: Up to three-weeks
System Usability Scale (0-100 higher scores indicate 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 percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.
Time frame: Up to three-weeks
PointCheck's Accuracy
To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, AUROC) to detect severe neutropenia compared with the gold standard blood analysis method employed by the 12 de Octubre Hospital core laboratory in the range between ≤500 and \>500 ANC/µL.
Time frame: Up to three-weeks
PointCheck's Utility
To evaluate the % 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
PointCheck's Safety: total number (%) of AEs and SAEs
The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
Time frame: Up to three-weeks
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