NCT06342284

Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: The New York Proton Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Thoracic Cancer

Interventions

Type	Name	Description
RADIATION	Proton Beam Radiation with or without concurrent chemotherapy	Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy

Timeline

• Start date: 2024-03-22
• Primary completion: 2028-03-01
• Completion: 2031-03-21
• First posted: 2024-04-02
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States