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
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
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 |
|---|---|
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Experimental: Personalized Exercise Program
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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. |
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No Intervention: Standard of Care - No Exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility Performance - Six Minute Walk (6MW) Distance
Time Frame: 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)
|
Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes.
This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the Change Short Physical Performance Battery (SPPB) Score
Time Frame: 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)
|
This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention). |
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)
|
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FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
Time Frame: 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 the study therapy)
|
The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at 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 the study therapy). |
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 the study therapy)
|
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Fatigue Subscale (FS)
Time Frame: 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)
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This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4). |
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)
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BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Time Frame: 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)
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This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation. |
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)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ulrich CM, Himbert C, Boucher K, Wetter DW, Hess R, Kim J, Lundberg K, Ligibel JA, Barnes CA, Rushton B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK. Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial. BMJ Open. 2018 Dec 16;8(12):e024672. doi: 10.1136/bmjopen-2018-024672.
- Ulrich CM, Himbert C, Barnes CA, Boucher KM, Daniels B, Bandera VM, Ligibel JA, Wetter DW, Hess R, Kim J, Lundberg K, Mitzman B, Marcus R, Finlayson SRG, LaStayo PC, Varghese TK Jr. Precision Exercise Effect on Fatigue and Function in Lung Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):495-519. doi: 10.1001/jamasurg.2025.0130.
- Assmann ES, Ose J, Hathaway CA, Oswald LB, Hardikar S, Himbert C, Chellam V, Lin T, Daniels B, Kirchhoff AC, Gigic B, Grossman D, Tward J, Varghese TK Jr, Shibata D, Figueiredo JC, Toriola AT, Beck A, Scaife C, Barnes CA, Matsen C, Ma DS, Colman H, Hunt JP, Jones KB, Lee CJ, Larson M, Onega T, Akerley WL, Li CI, Grady WM, Schneider M, Dinkel A, Islam JY, Gonzalez BD, Otto AK, Penedo FJ, Siegel EM, Tworoger SS, Ulrich CM, Peoples AR. Risk factors and health behaviors associated with loneliness among cancer survivors during the COVID-19 pandemic. J Behav Med. 2024 Jun;47(3):405-421. doi: 10.1007/s10865-023-00465-z. Epub 2024 Feb 28.
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
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