Active — Not RecruitingNot Applicable

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

United States30 participantsStarted 2022-08-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Feasibility of using the remote system to capture symptoms associated with TKI administration.

Timeframe: 24 Weeks

Trial details

NCT IDNCT05370469

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-14