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

Plain-language summary

This study evaluates real-time monitoring of symptoms, using a smartwatch application, a Fitbit device and surveys, in lung cancer patients receiving oral targeted therapy (tyrosine kinase inhibitors). It enrolls patients aged 18 and older with non-small cell lung cancer (NSCLC) that has an actionable mutation. It is a study without an assigned phase and is currently active but not recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

University of Virginia

Intervention

Sensus Smartwatch Application, RX Cap, Fitbit Sense, Surveys

Start date

8/25/2022

Estimated completion

5/1/2026

Countries

United States

Related genes

Locations

• Charlottesville, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.