Lung CancerLung001NCT05370469
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies
A study testing Sensus Smartwatch Application, RX Cap and Fitbit Sense in people with Lung Cancer and EGFR Gene Mutation, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, EGFR Gene Mutation, EGFR
- What is being tested?
- Sensus Smartwatch Application, RX Cap and Fitbit Sense
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With Actionable Mutations
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.
Read more
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.
Read the 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 choice and dose of TKI will be at the discretion of the treating medical oncologist. The study will assess symptoms and adverse events using a remote monitoring system that uses brief self-report surveys and passive input from smart devices as well as clinical assessment of adverse events and quality of life during routine office visits. An application loaded onto a smart phone (Sensus) and a fitness tracking device (Fitbit Sense) will capture information about symptoms and adverse events. This information will be captured through surveys and from passive input from the smart devices. Surveys will also be used to capture the subjects' experience with the devices. The results of this pilot study will be used to guide future development of a mobile health system application for remote real-time symptom monitoring to implement earlier interventions to reduce severity of symptoms, improve quality of life, and avoid drug discontinuations and dose reductions in this patient population.
- Conditions
- Lung Cancer, EGFR Gene Mutation, EGFR, ALK Gene Mutation, RET Gene Mutation, MET Gene Mutation
- Being tested
- Sensus Smartwatch Application, RX Cap, Fitbit Sense, Surveys
- Keywords
- EGFR gene mutation, EGFR, ALK, Fitbit, Tyrosine kinase inhibitor, TKI, Fitbit Sense, Sensus, RX Cap, Smart pill cap, Smart cap, Smartphone, Smartwatch, Fitness watch, Remote monitoring, survey, RET mutation, MET mutation, KRAS mutation, BRAF mutation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensus Smartwatch ApplicationOther
Sensus is capable of administering ecological momentary assessments (EMAs) on a schedule, randomly, or using sensor-triggers. In this way, Sensus will capture both active (patient-initiated) and passive data streams from native smartphone sensors. Passive streams may include, but are not limited to, GPS, accelerometer, gyroscope, and pedometer data. Participants will be able to log data such as their activity, symptoms and medication adherence via user-initiated surveys within the Sensus app. Sensus will also prompt users to record their medication adherence, symptoms, or activity. This will be done either at fixed intervals (e.g., three times daily) or whenever the onboard sensors detect potential changes in a user's physiological state (e.g., shaking / moving around).
RX CapDevice
The RXCap medication event monitoring device will be used to collect data on participant adherence to their TKI medication. A small computer chip is included in the top of a pill bottle. When the cap is taken off of the pill bottle by turning it or unscrewing it, the cap records the time and date that it was removed.
Fitbit SenseDevice
The Fitbit Sense smartwatch will be used to collect data including steps, calories burned, total distance travelled, sleep (e.g. time spent sleeping and quality of sleep), flights of stairs climbed, active minutes, exercise (e.g. minutes spent exercising at various intensities), and average heart rate.
SurveysOther
Electronic and paper surveys will be administered throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks. Receives: Other: Sensus Smartwatch Application; Device: RX Cap; Device: Fitbit Sense; Other: Surveys |
| Cohort B | Experimental | Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks. Receives: Other: Sensus Smartwatch Application; Device: RX Cap; Device: Fitbit Sense; Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the remote system to capture symptoms associated with TKI administration.
Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.
Measured: 24 Weeks
Secondary outcomes (1)
Estimate frequency and severity of adverse events
Adverse event frequency and severity recorded by the app and from in-person clinical assessments using the CTCAE v5.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start25 Aug 2022
- Primary completion14 Jun 2024
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Gentzler, MD, University of Virginia
- Investigators
- Ryan Gentzler, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370469
- Sponsor's protocol ID
- HSR210257
- Acronym
- Lung001
- Status last verified
- Nov 2025
- First submitted
- 6 May 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With Actionable Mutations
- ClinicalTrials.gov ID
- NCT05370469
- Acronym / sponsor ID
- Lung001 / HSR210257
- Conditions
- Lung Cancer, EGFR Gene Mutation, EGFR, ALK Gene Mutation, RET Gene Mutation, MET Gene Mutation
- Keywords
- EGFR gene mutation, EGFR, ALK, Fitbit, Tyrosine kinase inhibitor, TKI, Fitbit Sense, Sensus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 choice and dose of TKI will be at the discretion of the treating medical oncologist. The study will assess symptoms and adverse events using a remote monitoring system that uses brief self-report surveys and passive input from smart devices as well as clinical assessment of adverse events and quality of life during routine office visits. An application loaded onto a smart phone (Sensus) and a fitness tracking device (Fitbit Sense) will capture information about symptoms and adverse events. This information will be captured through surveys and from passive input from the smart devices. Surveys will also be used to capture the subjects' experience with the devices. The results of this pilot study will be used to guide future development of a mobile health system application for remote real-time symptom monitoring to implement earlier interventions to reduce severity of symptoms, improve quality of life, and avoid drug discontinuations and dose reductions in this patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Other: Sensus Smartwatch Application, Device: RX Cap, Device: Fitbit Sense, Other: SurveysSubjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks. |
| Cohort B | Experimental | Other: Sensus Smartwatch Application, Device: RX Cap, Device: Fitbit Sense, Other: SurveysSubjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensus Smartwatch ApplicationSensus is capable of administering ecological momentary assessments (EMAs) on a schedule, randomly, or using sensor-triggers. In this way, Sensus will capture both active (patient-initiated) and passive data streams from native smartphone sensors. Passive streams may include, but are not limited to, GPS, accelerometer, gyroscope, and pedometer data. Participants will be able to log data such as their activity, symptoms and medication adherence via user-initiated surveys within the Sensus app. Sensus will also prompt users to record their medication adherence, symptoms, or activity. This will be done either at fixed intervals (e.g., three times daily) or whenever the onboard sensors detect potential changes in a user's physiological state (e.g., shaking / moving around). | Other | Cohort A, Cohort B |
| RX CapThe RXCap medication event monitoring device will be used to collect data on participant adherence to their TKI medication. A small computer chip is included in the top of a pill bottle. When the cap is taken off of the pill bottle by turning it or unscrewing it, the cap records the time and date that it was removed. | Device | Cohort A, Cohort B |
| Fitbit SenseThe Fitbit Sense smartwatch will be used to collect data including steps, calories burned, total distance travelled, sleep (e.g. time spent sleeping and quality of sleep), flights of stairs climbed, active minutes, exercise (e.g. minutes spent exercising at various intensities), and average heart rate. | Device | Cohort A, Cohort B |
| SurveysElectronic and paper surveys will be administered throughout the study. | Other | Cohort A, Cohort B |
Primary outcome
Feasibility of using the remote system to capture symptoms associated with TKI administration.
Time frame: 24 Weeks
Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.
1 secondary outcome
Estimate frequency and severity of adverse events
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Gentzler, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensus Smartwatch Application, RX Cap and Fitbit Sense in people with Lung Cancer and EGFR Gene Mutation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using the remote system to capture symptoms associated with TKI administration. (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.