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

Primary Purpose

Non Small Cell Lung Cancer, Secondary Lung Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Personalized Exercise Program

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personalized Exercise Program

Standard of Care - No Exercise

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months

Results from PROMIS questionnaires.

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

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.

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.

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.

Full Information

NCT ID

NCT03306992

First Posted

September 29, 2017

Last Updated

June 6, 2023

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03306992

Brief Title

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

Acronym

PEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

November 7, 2017 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Secondary Lung Cancer

Keywords

Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Personalized Exercise Program

Arm Type

Experimental

Arm Title

Standard of Care - No Exercise

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Personalized Exercise Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluate the change in mobility performance at baseline, 2 months and 6 months

Description

Time Frame

Done at baseline, 2 and 6 months

Secondary Outcome Measure Information:

Title

Evaluate the change Short Physical Performance Battery (SPPB) score

Description

Time Frame

Done at baseline, 2 and 6 months

Title

Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months

Description

Results from PROMIS questionnaires.

Time Frame