Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05370469
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2022-05-06
Brief Title:
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lung001
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 participants 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
a smartphone application app developed at the University of Virginia called Sensus Sensus will be downloaded to the participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None