Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878952
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2021-04-30
Brief Title:
Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer LA-NSCLC
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
will not be able to meet study accrual objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment
Detailed Description:
PRIMARY OBJECTIVE
To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course
SECONDARY OBJECTIVES
I To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial
II To examine the association between baseline activity level and clinical outcomes related to treatment tolerance quality of life chemoradiotherapy adverse events and physical function preservation
III To demonstrate associations between daily step counts and short-term hospitalization risk
IV To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters
EXPLORATORY OBJECTIVES
I To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer
II To examine the association between baseline activity level with progression free survival and overall survival
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Usual Care
ARM II Usual Care Continuous physical activity monitoring via a wearable device
Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy
To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course
SECONDARY OBJECTIVES
I To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial
II To examine the association between baseline activity level and clinical outcomes related to treatment tolerance quality of life chemoradiotherapy adverse events and physical function preservation
III To demonstrate associations between daily step counts and short-term hospitalization risk
IV To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters
EXPLORATORY OBJECTIVES
I To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer
II To examine the association between baseline activity level with progression free survival and overall survival
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Usual Care
ARM II Usual Care Continuous physical activity monitoring via a wearable device
Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy
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