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

Not Applicable

Active, not recruiting

• Conditions: EGFR Gene Mutation; MET Gene Mutation; BRAF; ALK Gene Mutation; Lung Cancer; KRAS Mutation-Related Tumors; EGFR; RET Gene Mutation; ROS1 Gene Mutation
• Interventions: Other: Sensus Smartwatch Application; Device: RX Cap; Device: Fitbit Sense; Other: Surveys

• Registration Number: NCT05370469
• Lead Sponsor: University of Virginia

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Study Start: 2022-08-25
• Primary Completion: 2024-06-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, ≥18 years of age
• Diagnosis of non-small cell lung cancer (NSCLC) with an actionable mutation
• Currently prescribed oral tyrosine kinase inhibitors (TKIs). Participants may or may not have started taking the TKI prior to enrollment on this study. Participants who are initiating TKI treatment or are within 4 weeks of initiation of TKI treatment will be eligible for Cohort A. Participants who have been receiving TKIs for 4 or more weeks will be eligible for Cohort B.
• Owns a smartphone or tablet
• Ability and willingness to download and use a smart device application for the purposes of this study. Ability and willingness to use a Fitbit watch for the purposes of this study.
• Must have the ability to access WiFi or a device with mobile network (3G, 4G, 5G, etc.) connectivity during the course of the study
• Must be English speaking

Exclusion Criteria

• Any physical or cognitive impairment that would prevent the subject from using the study devices or participate in the study procedures.
• Any ongoing clinically significant grade ≥2 adverse events attributed to a previously prescribed TKI that is a different TKI from the one prescribed at enrollment for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B	Fitbit Sense	Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.
Cohort A	Sensus Smartwatch Application	Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.
Cohort A	RX Cap	Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.
Cohort A	Surveys	Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.
Cohort B	Sensus Smartwatch Application	Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.
Cohort B	Surveys	Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.
Cohort A	Fitbit Sense	Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.
Cohort B	RX Cap	Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility of using the remote system to capture symptoms associated with TKI administration.	24 Weeks	Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.

Secondary Outcome Measures

Name	Time	Method
Estimate frequency and severity of adverse events	24 Weeks	Adverse event frequency and severity recorded by the app and from in-person clinical assessments using the CTCAE v5.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States