<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306992</url>
  </required_header>
  <id_info>
    <org_study_id>HCI104671</org_study_id>
    <secondary_id>5R01CA211705-05</secondary_id>
    <nct_id>NCT03306992</nct_id>
  </id_info>
  <brief_title>Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study</brief_title>
  <acronym>PEP</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3 study aimed at investigating the effects of a personalized exercise program&#xD;
      (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing&#xD;
      surgical treatment at the University of Utah and comparing the intervention to the current&#xD;
      standard of care (no exercise program).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3 study aimed at investigating the effects of a personalized exercise program&#xD;
      (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients undergoing&#xD;
      surgical treatment at the University of Utah and comparing the intervention to the current&#xD;
      standard of care (no exercise program).&#xD;
&#xD;
      Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery and&#xD;
      will be followed for approximately 6 months post-surgery:&#xD;
&#xD;
        -  An Intervention Arm (referred to in materials as Group 1) which features pre- and&#xD;
           post-surgery PEP interventions.&#xD;
&#xD;
        -  A Control Arm (referred to in materials as Group 2) which does not include a&#xD;
           personalized exercise program (the standard of care). Patients randomized to the Control&#xD;
           Arm will be given the opportunity to participate in a PEP-intervention session providing&#xD;
           exercise counseling after the 6 month assessment and will receive a free activity&#xD;
           tracker for their participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the change in mobility performance at baseline, 2 months and 6 months</measure>
    <time_frame>Done at baseline, 2 and 6 months</time_frame>
    <description>Six Minute Walk (6MW) distance.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the change Short Physical Performance Battery (SPPB) score</measure>
    <time_frame>Done at baseline, 2 and 6 months</time_frame>
    <description>Short Physical Performance Battery (SPPB) test scores&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare results from PROMIS Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</measure>
    <time_frame>Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</time_frame>
    <description>Results from PROMIS questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</time_frame>
    <description>Results from FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</time_frame>
    <description>Results from FACIT-F (Chronic Illness Fatigue Scale) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare results from PSQI (Pittsburgh Sleep Quality Index) Questionnaire done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</measure>
    <time_frame>Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</time_frame>
    <description>Results from PSQI (Pittsburgh Sleep Quality Index) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Done at baseline, discharge (6-10 days after surgery on average), 2 and 6 months</time_frame>
    <description>Results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Secondary Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Personalized Exercise Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care - No Exercise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized Exercise Program</intervention_name>
    <description>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).&#xD;
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.</description>
    <arm_group_label>Personalized Exercise Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject aged ≥ 18 years.&#xD;
&#xD;
          -  Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung cancer.&#xD;
&#xD;
          -  Disease amenable to surgical resection in the opinion of the treating surgeon.&#xD;
&#xD;
          -  Patients must be able to follow directions and complete questionnaires and exercise&#xD;
             diaries in English.&#xD;
&#xD;
          -  Patients must agree to be randomly assigned to either Intervention or Control Group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deemed ineligible for surgery by the enrolling physician&#xD;
&#xD;
          -  Abnormalities on screening physical exam judged by study physicians or supervising&#xD;
             physical therapist to contraindicate participation in exercise program compliance.&#xD;
&#xD;
          -  Alcohol or drug abuse as judged by study physicians.&#xD;
&#xD;
          -  Significant mental or emotional problems that would interfere with study participation&#xD;
             will be assessed by the NCCN Distress Thermometer. Any value higher than 7 will&#xD;
             trigger further intervention, but ultimately enrollment into the clinical trial will&#xD;
             be determined by the enrolling physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03306992/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306992
org study id: HCI104671
secondary id: 5R01CA211705-05
nct id: NCT03306992
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the change in mobility performance at baseline, 2 months and 6 months
time frame: Done at baseline, 2 and 6 months
description: 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.
measure: Evaluate the change Short Physical Performance Battery (SPPB) score
time frame: Done at baseline, 2 and 6 months
description: 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.
measure: 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
description: Results from PROMIS questionnaires.
measure: 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
description: Results from FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire
measure: 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
description: Results from FACIT-F (Chronic Illness Fatigue Scale) questionnaire.
measure: 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
description: Results from PSQI (Pittsburgh Sleep Quality Index) questionnaire.
measure: 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
description: Results from BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) questionnaire.
arm group label: Personalized Exercise Program
arm group type: Experimental
arm group label: Standard of Care - No Exercise
arm group type: No Intervention
intervention type: Behavioral
intervention name: Personalized Exercise Program
description: 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.
arm group label: Personalized Exercise Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Neoplasm Metastasis
provided document: 