Status:

COMPLETED

Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study

Lead Sponsor:

University of Utah

Collaborating Sponsors:

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Conditions:

Non Small Cell Lung Cancer

Secondary Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 treatme...

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 treatme...

Eligibility Criteria

Inclusion

  • Male or female subject aged ≥ 18 years.
  • Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung cancer.
  • Disease amenable to surgical resection in the opinion of the treating surgeon.
  • Patients must be able to follow directions and complete questionnaires and exercise diaries in English.
  • Patients must agree to be randomly assigned to either Intervention or Control Group.

Exclusion

  • Deemed ineligible for surgery by the enrolling physician
  • Abnormalities on screening physical exam judged by study physicians or supervising physical therapist to contraindicate participation in exercise program compliance.
  • Alcohol or drug abuse as judged by study physicians.
  • Significant mental or emotional problems that would interfere with study participation will be assessed by the NCCN Distress Thermometer. Any value higher than 7 will trigger further intervention, but ultimately enrollment into the clinical trial will be determined by the enrolling physician.

Key Trial Info

Start Date :

November 7 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03306992

Start Date

November 7 2017

End Date

May 31 2022

Last Update

June 7 2023

Active Locations (1)

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1

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112