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

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer; Secondary Lung Cancer
• Interventions: Behavioral: Personalized Exercise Program

• Registration Number: NCT03306992
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-11
• Study Start: 2017-11-07
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Exercise Program	Personalized Exercise Program	-

Primary Outcome Measures

Name	Time	Method
Evaluate the change in mobility performance at baseline, 2 months and 6 months	Done at baseline, 2 and 6 months	Six Minute Walk (6MW) distance.; The distance patients can walk indoors on a 25 meters level smooth-surfaced track over the course of 6 minutes will be measured at baseline as well as at the time of discharge and at the 2 and 6 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Results from PROMIS questionnaires.
Evaluate the change Short Physical Performance Battery (SPPB) score	Done at baseline, 2 and 6 months	Short Physical Performance Battery (SPPB) test scores; A secondary endpoint associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 1 to 12) will be obtained for each patient at the time points described above. Medians will be obtained and compared for each arm.
Compare results from FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Results from FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire
Compare results from FACIT-F (Chronic Illness Fatigue Scale) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Results from FACIT-F (Chronic Illness Fatigue Scale) questionnaire.
Compare results from PSQI (Pittsburgh Sleep Quality Index) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Results from PSQI (Pittsburgh Sleep Quality Index) questionnaire.
Compare results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months	Results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) questionnaire.

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States