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Smartwatch and app aim to track lung cancer symptoms in real time

NCT ID NCT05370469

Knowledge-focused Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a remote monitoring system—including a smartphone app, a Fitbit, and a smart pill cap—can effectively track symptoms and side effects in 30 lung cancer patients taking oral targeted therapy. Participants will use the system for up to 24 weeks, and the goal is to see if it's feasible to capture symptom data in real time. The results will help design better ways to manage treatment side effects and improve quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remote monitoring system (smartphone app, Fitbit, smart pill cap)
What this could lead to
If successful, this could lead to a real-time symptom tracking system that helps doctors better manage side effects and improve quality of life for lung cancer patients.
What could go wrong
This is a small, early feasibility study with only 30 participants, so results may not apply to all patients. The system relies on patients consistently using the devices, which may be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Aug 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALK gene mutation BRAF EGFR EGFR gene mutation KRAS mutation-related tumors Lung cancer MET gene mutation RET gene mutation ROS1 gene mutation

Contacts and locations

Locations

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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