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

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.

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

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.

Sponsors & Collaborators

• University of Virginia

  lead OTHER

Principal Investigators

• Ryan Gentzler, MD · University of Virginia

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-25

Primary Completion

2024-06-14

Completion

2026-05-31

Countries

• United States

Study Locations