Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 7:24 AM
Study NCT ID:
NCT03306992
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2017-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
A Phase III Randomized Study Comparing the Effects of a Personalized Exercise Program (PEP) Against No Intervention in Patients With Stage I-IIIa Primary Non-Small Cell Lung Cancer or Secondary Lung Cancer Undergoing Surgical Resection
Status:
COMPLETED
Status Verified Date:
2023-06
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:
PEP
Brief Summary:
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
Detailed Description:
This is a Phase 3 study aimed at investigating the effects of a personalized exercise program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing surgical treatment at the University of Utah and comparing the intervention to the current standard of care (no exercise program).
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and will be followed for approximately 6 months post-surgery:
* An Intervention Arm (referred to in materials as Group 1) which features pre- and post-surgery PEP interventions.
* A Control Arm (referred to in materials as Group 2) which does not include a personalized exercise program (the standard of care). Patients randomized to the Control Arm will be given the opportunity to participate in a PEP-intervention session providing exercise counseling after the 6 month assessment and will receive a free activity tracker for their participation.
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and will be followed for approximately 6 months post-surgery:
* An Intervention Arm (referred to in materials as Group 1) which features pre- and post-surgery PEP interventions.
* A Control Arm (referred to in materials as Group 2) which does not include a personalized exercise program (the standard of care). Patients randomized to the Control Arm will be given the opportunity to participate in a PEP-intervention session providing exercise counseling after the 6 month assessment and will receive a free activity tracker for their participation.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01CA211705-05 | NIH | None | https://reporter.nih.gov/quic… | View |