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

Primary Purpose

Lung Cancer, EGFR Gene Mutation, EGFR

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sensus Smartwatch Application

RX Cap

Fitbit Sense

Surveys

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring 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, ROS1 mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05370469

First Posted

May 6, 2022

Last Updated

July 7, 2023

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT05370469

Brief Title

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

Acronym

Lung001

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 25, 2022 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, EGFR Gene Mutation, EGFR, ALK Gene Mutation, RET Gene Mutation, MET Gene Mutation, KRAS Mutation-Related Tumors, BRAF, ROS1 Gene Mutation

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, ROS1 mutation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Description

Arm Title

Cohort B

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Sensus Smartwatch Application

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

RX Cap

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Fitbit Sense

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Surveys

Intervention Description

Electronic and paper surveys will be administered throughout the study.

Primary Outcome Measure Information:

Title

Feasibility of using the remote system to capture symptoms associated with TKI administration.

Description

Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

Estimate frequency and severity of adverse events

Description

Adverse event frequency and severity recorded by the app and from in-person clinical assessments using the CTCAE v5.

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Morgan van Ornum

Phone

(434) 297-4579

NQK9GS@uvahealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Lacey Botteon

Phone

(434) 297-5588

LB5TU@hscmail.mcc.virginia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Gentzler, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ryan Gentzler, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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