NCT05370469

Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies

Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With Actionable Mutations

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients who are taking oral tyrosine kinase inhibitor (TKI) therapy for lung cancer will be asked to participate in a remote monitoring system for up to 24 weeks. The system will include: * a smartphone application (app) developed at the University of Virginia called Sensus. Sensus will be downloaded to the participant's smartphone. The app will collect active data (such as through surveys) and passive data (such as accelerometer data). * a fitness watch called a Fitbit will be given to the participant to be used during the study. The Fitbit will collect information such as steps and average heart rate. * a smart pill cap called RX Cap will be given to the participant to be used during the study. The pill cap will collect information about how often a pill bottle is opened. The study will also involve paper surveys that are taken by the participant during clinic visits. Symptoms related to TKI therapy will be recorded by an investigator in the clinic. The study results will be used to guide development of a real-time symptom monitoring system, with the ultimate goal of improving TKI symptom response and quality of life.

Detailed description

This is a prospective pilot study for adult patients with lung cancer who have tumors harboring an actionable mutation and who are undergoing treatment with oral tyrosine kinase inhibitors (TKIs). The choice and dose of TKI will be at the discretion of the treating medical oncologist. The study will assess symptoms and adverse events using a remote monitoring system that uses brief self-report surveys and passive input from smart devices as well as clinical assessment of adverse events and quality of life during routine office visits. An application loaded onto a smart phone (Sensus) and a fitness tracking device (Fitbit Sense) will capture information about symptoms and adverse events. This information will be captured through surveys and from passive input from the smart devices. Surveys will also be used to capture the subjects' experience with the devices. The results of this pilot study will be used to guide future development of a mobile health system application for remote real-time symptom monitoring to implement earlier interventions to reduce severity of symptoms, improve quality of life, and avoid drug discontinuations and dose reductions in this patient population.

Conditions

• Lung Cancer
• EGFR Gene Mutation
• EGFR
• ALK Gene Mutation
• RET Gene Mutation
• MET Gene Mutation
• KRAS Mutation-Related Tumors
• BRAF
• ROS1 Gene Mutation

Interventions

Type	Name	Description
OTHER	Sensus Smartwatch Application	Sensus is capable of administering ecological momentary assessments (EMAs) on a schedule, randomly, or using sensor-triggers. In this way, Sensus will capture both active (patient-initiated) and passive data streams from native smartphone sensors. Passive streams may include, but are not limited to, GPS, accelerometer, gyroscope, and pedometer data. Participants will be able to log data such as their activity, symptoms and medication adherence via user-initiated surveys within the Sensus app. Sensus will also prompt users to record their medication adherence, symptoms, or activity. This will be done either at fixed intervals (e.g., three times daily) or whenever the onboard sensors detect potential changes in a user's physiological state (e.g., shaking / moving around).
DEVICE	RX Cap	The RXCap medication event monitoring device will be used to collect data on participant adherence to their TKI medication. A small computer chip is included in the top of a pill bottle. When the cap is taken off of the pill bottle by turning it or unscrewing it, the cap records the time and date that it was removed.
DEVICE	Fitbit Sense	The Fitbit Sense smartwatch will be used to collect data including steps, calories burned, total distance travelled, sleep (e.g. time spent sleeping and quality of sleep), flights of stairs climbed, active minutes, exercise (e.g. minutes spent exercising at various intensities), and average heart rate.
OTHER	Surveys	Electronic and paper surveys will be administered throughout the study.

Timeline

• Start date: 2022-08-25
• Primary completion: 2024-06-14
• Completion: 2026-05-01
• First posted: 2022-05-11
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States