NCT05370469Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Nov 2025

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 30 (actual)
First submitted: 6 May 2022
Start date: 25 Aug 2022
Primary completion date: 14 Jun 2024
Lead sponsor: University of Virginia
Diseases: Lung cancer
NCT number: NCT05370469

What you commit to

Study type: Interventional
Participants enrolled: 30
From 25 Aug 2022 to the primary completion date, 14 Jun 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Other illness

Any physical or cognitive impairment that would prevent the subject from using the study devices or participate in the study procedures.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Virginia Coordinator of this site? Confirm its status	Charlottesville	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.