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

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ClinicalTrials.gov Identifier: NCT03306992
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Utah

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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Secondary Lung Cancer Behavioral: Personalized Exercise Program Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized Exercise Program Behavioral: 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 meetings (~30-40 minutes) or during the weekly phone calls. 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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306992


Contacts
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Contact: Bailee Rushton 801-587-4699 bailee.rushton@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Bailee Rushton    801-587-4699    PEP.study@hci.utah.edu   
Principal Investigator: Paul LaStayo         
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)
  Study Documents (Full-Text)

Documents provided by University of Utah:
Study Protocol  [PDF] September 11, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03306992     History of Changes
Other Study ID Numbers: HCI104671
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Utah:
Exercise

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes