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

NAActive, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 25, 2022

Primary Completion Date

June 14, 2024

Study Completion Date

August 31, 2025

Conditions
Lung CancerEGFR Gene MutationEGFRALK Gene MutationRET Gene MutationMET Gene MutationKRAS Mutation-Related TumorsBRAFROS1 Gene Mutation
Interventions
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.

Trial Locations (1)

22908

University of Virginia, Charlottesville

All Listed Sponsors
lead

University of Virginia

OTHER