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

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 3

Conditions

Non Small Cell Lung Cancer

Secondary Lung Cancer

Treatments

Behavioral: Personalized Exercise Program

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03306992

5R01CA211705-05 (U.S. NIH Grant/Contract)

HCI104671

Details and patient eligibility

About

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).

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 exercise diaries in English.
Patients must agree to be randomly assigned to either Intervention or Control Group.

Exclusion criteria

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.