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Clinical Trial Summary

This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.


Clinical Trial Description

This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards. Primary Objective • To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer. Secondary Objective • To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer. Exploratory Objective • To explore associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06342284
Study type Observational
Source The New York Proton Center
Contact Nitin Ohri, MD
Phone 718-405-8550
Email nitin.ohri@einsteinmed.edu
Status Recruiting
Phase
Start date March 22, 2024
Completion date March 21, 2031

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