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

Last updated: June 6, 2023
Sponsor: University of Utah
Overall Status: Completed

Phase

3

Condition

Neoplasm Metastasis

Treatment

Personalized Exercise Program

Clinical Study ID

NCT03306992
HCI104671
5R01CA211705-05
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 exercisediaries in English.
  • Patients must agree to be randomly assigned to either Intervention or Control Group.

Exclusion

Exclusion Criteria:

  • Deemed ineligible for surgery by the enrolling physician
  • Abnormalities on screening physical exam judged by study physicians or supervisingphysical 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 participationwill be assessed by the NCCN Distress Thermometer. Any value higher than 7 willtrigger further intervention, but ultimately enrollment into the clinical trial willbe determined by the enrolling physician.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Personalized Exercise Program
Phase: 3
Study Start date:
November 07, 2017
Estimated Completion Date:
May 31, 2022

Study 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.

Connect with a study center

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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