NCT03306992

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4.6 years

First QC Date

September 29, 2017

Last Update Submit

June 6, 2023

Conditions

Non Small Cell Lung CancerSecondary Lung Cancer

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Evaluate the change Short Physical Performance Battery (SPPB) score

    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

    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

    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

    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

    Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Personalized Exercise Program

EXPERIMENTAL
Behavioral: Personalized Exercise Program

Standard of Care - No Exercise

NO INTERVENTION

Interventions

Personalized Exercise ProgramBEHAVIORAL

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.

Personalized Exercise Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (3)

  • 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.

    PMID: 40072448DERIVED

  • 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.

    PMID: 38418709DERIVED

  • 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.

    PMID: 30559162DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMotor Activity

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 11, 2017

Study Start

November 7, 2017

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

US(1)