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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non Small Cell Lung Cancer, Secondary Lung Cancer

Intervention / Treatment
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* Behavioral: Personalized Exercise Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Exercise Program<br> | Behavioral: Personalized Exercise Program<br>* The PEP intervention involves a combination of home-based exercise as well as in-patient exercise. The exercise modes will include basic transfer and calisthenics mobility, aerobic and resistance exercises and will be performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting). For patients randomized to the Intervention Group (Group 1), the PEP intervention will be personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings ( 30-40 minutes). An exercise education manual, specifically developed for this study, will be used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.<br>|
| No Intervention: Standard of Care - No Exercise<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change in mobility performance at baseline, 2 months 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. | Done at baseline, 2 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change Short Physical Performance Battery (SPPB) score | 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. | Done at baseline, 2 and 6 months | 
| Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months | Results from PROMIS questionnaires. | Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months | 
| 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 | 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 | 
| 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 | Results from FACIT-F (Chronic Illness Fatigue Scale) questionnaire. | Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months | 
| Compare results from PSQI (Pittsburgh Sleep Quality Index) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months | Results from PSQI (Pittsburgh Sleep Quality Index) questionnaire. | Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months | 
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise