ClinicalTrials.gg
CompletedNCT03306992PEPUpdated Jun 9, 2026Results posted

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

A Phase 3 interventional study of Personalized Exercise Program in Non Small Cell Lung Cancer and Secondary Lung Cancer, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by University of Utah · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Carcinoma, Non-Small-Cell Lung by University of Utah — 2 open to participants now, 3 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · University of Utah.

Started
2017
the only one that year
Phase 3
Only one
of the 10
Registered
5th of 10
by date

Among the 10 studies in Carcinoma, Non-Small-Cell Lung by University of Utah, this one is the only one that started in 2017, is the only one in phase 3, and was the 5th registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

2 of the 10 studies in Carcinoma, Non-Small-Cell Lung by University of Utah are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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).

Read the 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.
03

Conditions studied

  • Non Small Cell Lung Cancer
  • Secondary Lung Cancer

Keywords

  • Exercise
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (actual)

Study arms

  • Experimental
    Personalized Exercise Program

    Behavioral: Personalized Exercise Program

  • No intervention
    Standard of Care - No Exercise

Interventions

  • BehavioralPersonalized 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.

06

What researchers measure

Primary outcomes

  1. Mobility Performance - Six Minute Walk (6MW) Distance

    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).

    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)

Secondary outcomes

  1. Evaluate the Change Short Physical Performance Battery (SPPB) Score

    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).

    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)

  2. FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire

    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).

    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)

  3. Fatigue Subscale (FS)

    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).

    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)

  4. BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire

    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.

    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)

07

Results

Posted Jun 9, 2026

Participant flow

Hospital Discharge to 2 Month Follow up
Participant flow — Hospital Discharge to 2 Month Follow up
MilestonePersonalized Exercise ProgramStandard of Care - No Exercise
Started9290
Completed8285
Not completed105
Withdrew: Withdrawal by subject72
Withdrew: Death01
Withdrew: Did not perform 6mw test32
2 Month to 6 Month Follow up
Participant flow — 2 Month to 6 Month Follow up
MilestonePersonalized Exercise ProgramStandard of Care - No Exercise
Started8285
Completed8282
Not completed03
Withdrew: Death03

Outcome measures

PrimaryMobility Performance - Six Minute Walk (6MW) Distance

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).

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)
Reported as:
Mean · meters
Mobility Performance - Six Minute Walk (6MW) Distance
metersPersonalized Exercise ProgramStandard of Care - No Exercise
Hospital Discharge409.8 ± 169.8411.0 ± 164.3
2-Month Post Surgery Visit490.5 ± 127.6475.9 ± 129.5
6-Month Post Surgery Visit483.1 ± 151.9463.3 ± 180
SecondaryEvaluate the Change Short Physical Performance Battery (SPPB) Score

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).

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)
Reported as:
Median · score on a scale
Evaluate the Change Short Physical Performance Battery (SPPB) Score
score on a scalePersonalized Exercise ProgramStandard of Care - No Exercise
Hospital Discharge11 (9 to 12)11.5 (8.5 to 12)
2-Month Post Surgery Visit12 (11 to 12)12 (10 to 12)
6-Month Post Surgery Visit12 (11 to 12)12 (11 to 12)
SecondaryFACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire

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).

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)
Reported as:
Mean · score on a scale
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
score on a scalePersonalized Exercise ProgramStandard of Care - No Exercise
Hospital Discharge100 ± 18.1101.5 ± 17.0
2-Month Follow up106.4 ± 14.8103.5 ± 17.1
6-Month Follow up106.5 ± 16105.9 ± 15.7
SecondaryFatigue Subscale (FS)

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).

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)
Reported as:
Mean · score on a scale
Fatigue Subscale (FS)
score on a scalePersonalized Exercise ProgramStandard of Care - No Exercise
Hospital Discharge34.5 ± 11.433.5 ± 12.1
2 Month Follow-up Visit38.6 ± 8.736 ± 10.7
6-Month Follow-up38.2 ± 10.237.5 ± 11.3
SecondaryBREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire

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.

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)
Reported as:
Mean · score on a scale
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
score on a scalePersonalized Exercise ProgramStandard of Care - No Exercise
Discharge: Amotivation0.2 ± 0.50.2 ± 0.5
Discharge: External Regulation0.8 ± 1.10.9 ± 1.0
Discharge: Introjected Regulation1.7 ± 1.11.7 ± 1
Discharge: Identified Regulation2.9 ± .82.8 ± 0.9
Discharge: Integrated Regulation2.2 ± 1.32.1 ± 1.2
Discharge: Intrinsic Regulation2.3 ± 1.22.3 ± 1.2
2-Month: Amotivation0.1 ± 0.30.2 ± 0.4
2-Month: External Regulation0.8 ± 10.90 ± 1
2-Months: Introjected Regulation1.7 ± 1.11.7 ± 1.1
2-Months: Identified Regulation3.0 ± 0.72.9 ± 0.9
2-Months: Integrated Regulation2.2 ± 1.12.1 ± 1.2
2-Months: Intrinsic Regulation2.2 ± 12.3 ± 1.1
6-Months: Amotivation0.2 ± 0.40.3 ± 0.6
6-Months: External Regulation0.8 ± 1.00.8 ± 1.0
6-Months: Introjected Regulation1.9 ± 1.11.8 ± 1.2
6-Months: Identified Regulation3.1 ± 0.82.9 ± 0.9
6-Months: Integrated Regulation2.4 ± 1.22.3 ± 1.1
6-Months: Intrinsic Regulation2.4 ± 1.12.4 ± 1.2

Adverse events

Collected over Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Personalized Exercise Program0/92 (0%)0/92 (0%)5/92 (5.4%)
Standard of Care - No Exercise4/90 (4.4%)0/90 (0%)0/90 (0%)
Most frequent other events
Most frequent other events
EventPersonalized Exercise ProgramStandard of Care - No Exercise
Pain in extremityMusculoskeletal and connective tissue disorders2/920/90
Muscle weakness lower limbMusculoskeletal and connective tissue disorders1/920/90
Joint range of motion decreased cervical spineMusculoskeletal and connective tissue disorders1/920/90
MyalgiaMusculoskeletal and connective tissue disorders1/920/90
Joint range of motion decreasedMusculoskeletal and connective tissue disorders1/920/90

Baseline characteristics

Age, Continuous
Age, Continuous(years)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
Mean62.7 ± 14.762.7 ± 13.062.7 ± 13.8
Sex: Female, Male
Sex: Female, Male(Participants)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
Female5157108
Male413374
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
Hispanic or Latino4610
Not Hispanic or Latino8683169
Unknown or Not Reported213
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American101
White8683169
More than one race123
Unknown or Not Reported347
Region of Enrollment
Region of Enrollment(participants)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
United States9290182
Rural-Urban Status
Rural-Urban Status(Participants)Personalized Exercise ProgramStandard of Care - No ExerciseTotal
Urban8275157
Rural101525
08

Study locations

1 site
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
09

References and documents

Publications

  • 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. PubMed 40072448 ↗
  • 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. PubMed 38418709 ↗
  • 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. PubMed 30559162 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in May 2022, 54 months.

Results were first posted in Jun 2026, 4 years after primary completion.

Of 109 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 129. This study's 54 months is below that.

Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2017
First posted
Oct 11, 2017
StartActual
Nov 7, 2017
Primary completionActual
May 31, 2022
CompletionActual
May 31, 2022
Results first posted
Jun 9, 2026
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03306992
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Nov 7, 2017
Primary completion
May 31, 2022
Completion
May 31, 2022
Results posted
Jun 9, 2026
Last update
Jun 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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