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Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies (Lung001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05370469
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Ryan Gentzler, MD, University of Virginia

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 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.


Condition or disease Intervention/treatment Phase
Lung Cancer EGFR Gene Mutation EGFR ALK Gene Mutation Other: Sensus Smartwatch Application Device: RX Cap Device: Fitbit Sense Other: Surveys Not Applicable

Detailed Description:
This is a prospective pilot study for adult patients with lung cancer who have tumors harboring oncogenic driver mutations in EGFR or ALK and who are undergoing treatment with oral tyrosine kinase inhibitors (TKIs). Male or female adults with lung cancer who have tumors harboring oncogenic driver mutations in EGFR or ALK and who are undergoing treatment with TKIs will be enrolled. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With EGFR Mutations or ALK Rearrangements
Actual Study Start Date : August 25, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cohort A
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.
Other: Sensus Smartwatch Application
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).

Device: RX Cap
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.

Device: Fitbit Sense
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.

Other: Surveys
Electronic and paper surveys will be administered throughout the study.

Experimental: Cohort B
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.
Other: Sensus Smartwatch Application
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).

Device: RX Cap
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.

Device: Fitbit Sense
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.

Other: Surveys
Electronic and paper surveys will be administered throughout the study.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Estimate frequency and severity of adverse events [ Time Frame: 24 Weeks ]
    Adverse event frequency and severity recorded by the app and from in-person clinical assessments using the CTCAE v5.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 lung cancer with presence of an oncogenic driver mutations in EGFR or ALK
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05370469


Contacts
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Contact: Jemima Tennant, MPH, CPH (434) 243-8259 jjt5gc@uvahealth.org
Contact: Lacey Botteon (434) 297-5588 LB5TU@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ryan Gentzler, MD         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Ryan Gentzler, MD University of Virginia
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Responsible Party: Ryan Gentzler, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT05370469    
Other Study ID Numbers: HSR210257
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Gentzler, MD, University of Virginia:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases