Status:
ACTIVE_NOT_RECRUITING
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies
Lead Sponsor:
University of Virginia
Conditions:
Lung Cancer
EGFR Gene Mutation
Eligibility:
All Genders
18+ years
Phase:
NA
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 inclu...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05370469
Start Date
August 25 2022
End Date
May 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908