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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-07

Study Completion Date

2022-05-31

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).

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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.

Conditions

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Non Small Cell Lung Cancer Secondary Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Personalized Exercise Program

Group Type EXPERIMENTAL

Personalized Exercise Program

Intervention Type BEHAVIORAL

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.

Standard of Care - No Exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personalized Exercise Program

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No