Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342284
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-20
Brief Title:
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
Sponsor:
The New York Proton Center
Organization:
The New York Proton Center
Study Overview
Official Title:
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
PGHD
Brief Summary:
This is an observational study involving the collection of patient-generated health data using an Apple Watch a home pulse oximeter and a smartphone during a course of proton beam radiotherapy for lung cancer The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion Subjects will complete a short satisfaction survey at the end of the study period Other information that is collected as part of routine care for this patient population will be extracted from subjects medical records during the study period and afterwards
Detailed Description:
This is an observational study involving the collection of patient-generated health data using an Apple Watch a home pulse oximeter and a smartphone during a course of proton beam radiotherapy for lung cancer The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion Subjects will complete a short satisfaction survey at the end of the study period Other information that is collected as part of routine care for this patient population will be extracted from subjects medical records during the study period and afterwards
Primary Objective
To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer
Secondary Objective To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer
Exploratory Objective
To explore associations between radiotherapy treatment parameters wearable device data patient-reported outcomes adverse events and long-term clinical outcomes
Primary Objective
To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer
Secondary Objective To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer
Exploratory Objective
To explore associations between radiotherapy treatment parameters wearable device data patient-reported outcomes adverse events and long-term clinical outcomes
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