Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513663
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Exercise as Maintenance Therapy in Advanced Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exercise as Maintenance Therapy in Advanced Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine how a multimodality having or using a variety of methods to do something exercise intervention may improve survival function and quality of life in participants with advanced lung cancer
Detailed Description:
This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program The regimen will be 12 weeks in duration three times a week and administered by a trained professional virtually
Participants will be randomized 11 to the exercise or usual care arm Participants will be stratified on baseline frailty by the SPPB
Primary Objective To compare changes patient-reported fatigue by FACT-F survey from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
Secondary Objectives
1 To compare changes in cardiorespiratory fitness measured by VO2peak estimated as time on the treadmill during ramp treadmill test from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
2 To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
3 To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
4 To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced andor advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
5 To compare the proportion of patients who are fatigued defined as a FACT-F score of 43 at post-intervention between the exercise and usual care arms
6 To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced andor advanced lung cancer receiving maintenance immunotherapy or targeted therapy measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm
Participants will be randomized 11 to the exercise or usual care arm Participants will be stratified on baseline frailty by the SPPB
Primary Objective To compare changes patient-reported fatigue by FACT-F survey from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
Secondary Objectives
1 To compare changes in cardiorespiratory fitness measured by VO2peak estimated as time on the treadmill during ramp treadmill test from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
2 To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
3 To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advancedadvanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
4 To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced andor advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care
5 To compare the proportion of patients who are fatigued defined as a FACT-F score of 43 at post-intervention between the exercise and usual care arms
6 To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced andor advanced lung cancer receiving maintenance immunotherapy or targeted therapy measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None