- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306992
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study (PEP)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
No Intervention: Standard of Care - No Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the change in mobility performance at baseline, 2 months and 6 months
Time Frame: 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. |
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
Time Frame: 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. |
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCI104671
- 5R01CA211705-05 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Personalized Exercise Program
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
Hadassah Medical OrganizationZinman College of Physical Education and Sports SciencesUnknownExercise | Healthy Older AdultsIsrael
-
Hospital General de México Dr. Eduardo LiceagaNational Council of Science and Technology, Mexico; Universidad Nacional Autonoma... and other collaboratorsUnknownLiver Diseases | Obesity | Metabolic Syndrome | Exercise | Childhood Obesity | Cardiovascular Risk FactorMexico
-
Basque Health ServiceCompletedQuality of Life | Cancer | Exercise | Functional CapacitySpain
-
Istituto Auxologico ItalianoRecruitingMetabolic Syndrome | Life Style, Healthy | Physical Inactivity | Hypogonadism, Male | Autonomic ImbalanceItaly
-
University of Southern DenmarkZealand University Hospital; Holbaek Sygehus; Naestved Hospital; Nykøbing Falster... and other collaboratorsActive, not recruitingDepression | Heart Failure | Hypertension | Chronic Obstructive Pulmonary Disease | Osteoarthritis, Knee | Coronary Heart Disease | Osteoarthritis, Hip | Type2 DiabetesDenmark
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruiting
-
Vastra Gotaland RegionCompleted
-
Intermountain Health Care, Inc.Deseret FoundationCompletedDementia | Alzheimer Disease | Memory DisordersUnited States
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of