Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study (NCT03306992) | Clinical Trial Compass
CompletedPhase 3
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study
United States182 participantsStarted 2017-11-07
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subject aged ≥ 18 years.
* Suspected (per the treating physician) 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a six-minute walk test to measure how far patients could walk before and after a precision exercise program — can you tell me whether my current fitness or walking ability would be relevant to interpreting results like these, and what they might mean for my own recovery from lung cancer surgery?
2Since this was a Phase 3 trial that has now completed, has the data been published, and if so, what did the results show about whether a tailored exercise program actually helped patients recover better after surgery for non-small cell lung cancer?
3The study focused on 'precision' exercise prescriptions, meaning exercise plans customized to each patient — is that something that could realistically be built into my care plan before or after my surgery, and do you think the evidence from a study like this supports trying it in my case?
4Given that this trial is now completed, are there any follow-on programs or clinical pathways at this hospital that were influenced by its findings, so I could potentially benefit from what was learned without enrolling in a study?
5Would my specific situation — including the type and stage of my lung cancer and my overall health — be comparable to the patients enrolled in this trial, and does that affect how much weight you'd put on its findings when planning my treatment and recovery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mobility Performance - Six Minute Walk (6MW) Distance
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)