Clinical trial · Interventional
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies
Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With Actionable Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK Gene Mutation | — | UNRESOLVED | — |
| BRAF | — | UNRESOLVED | — |
| EGFR | — | UNRESOLVED | — |
| EGFR Gene Mutation | — | UNRESOLVED | — |
| KRAS Mutation-Related Tumors | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| MET Gene Mutation | — | UNRESOLVED | — |
| RET Gene Mutation | — | UNRESOLVED | — |
| ROS1 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fitbit Sense | Device | — | UNRESOLVED |
| RX Cap | Device | — | UNRESOLVED |
| Sensus Smartwatch Application | Other | — | UNRESOLVED |
| Surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- 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.
- interventionNames
- Other: Sensus Smartwatch Application
- Device: RX Cap
- Device: Fitbit Sense
- Other: Surveys
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- 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.
- interventionNames
- Other: Sensus Smartwatch Application
- Device: RX Cap
- Device: Fitbit Sense
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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