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

Non Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306992
• Other study ID #: HCI104671
• Secondary ID: 5R01CA211705-05
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non Small Cell Lung Cancer
• Secondary Lung Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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