<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/NCT01682850</url>
  </required_header>
  <id_info>
    <org_study_id>11-005820</org_study_id>
    <secondary_id>1R01CA163293-01</secondary_id>
    <nct_id>NCT01682850</nct_id>
  </id_info>
  <brief_title>Pulmonary Rehabilitation Before Lung Cancer Resection</brief_title>
  <official_title>Pulmonary Rehabilitation Before Lung Cancer Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to study the effectiveness of a short mindfulness based pulmonary&#xD;
      rehabilitation program prior to a surgical resection in patients with lung cancer and severe&#xD;
      Chronic Obstructive Lung Disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of length of hospital stay post surgical resection of lung cancer in patients that underwent a resection for lung cancer.</measure>
    <time_frame>baseline to release from hospital - approx 10 days</time_frame>
    <description>The length of hospital stay will be compared between participants that under went 10 Mindful Rehabilitation Sessions with participants who received the usual care prior to a lung resection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure post-operative complications in patients that under went 10 session of Mindful Pulmonary Rehabilitation prior to lung resection compared to patients who received usual care prior to a lung resection for lung cancer.</measure>
    <time_frame>Post surgerybaseline to release from hospital - approx 10 days</time_frame>
    <description>The study will compare the number of ICU days, ventilation hours, number of days with a chest tube, subsequent pneumonia or respiratory failure in patients that underwent 10 Mindful Pulmonary Rehabilitation sessions prior to a lung resection to patients who received the usual care prior to a lung resection for lung cancer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Lung Cancer</condition>
  <condition>COPD</condition>
  <condition>Chronic Obstructive Lung Disease</condition>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Intervention Arm will receive 10 sessions of Mindfulness Based Pulmonary Rehabilitation prior to lung surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Usual Care Arm will receive the normal care that a patient with severe COPD having a lung surgery would receive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Based Pulmonary Rehabilitation</intervention_name>
    <description>Participants in this group will under go 10 sessions of mindfulness based pulmonary rehabilitation prior to surgery. Each session is about 2 hours long and consists of upper /lower extremity training, breathing exercises, and education.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is scheduled to undergo a surgery for non small cell lung cancer&#xD;
&#xD;
          -  Moderate to severe COPD&#xD;
&#xD;
          -  Current or ex smoker of ten or more years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to perform exercise due to active cardiovascular, musculoskeletal or mental&#xD;
             problems Poorly motivated to attend the rehabilitation sessions or receive&#xD;
             randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberto P Benzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Roberto P. Benzo</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Chronic Obstructive Lung Disease</keyword>
  <keyword>lung cancer</keyword>
  <keyword>emphysema</keyword>
  <keyword>Pulmonary Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01682850
org study id: 11-005820
secondary id: 1R01CA163293-01
nct id: NCT01682850
lead sponsor: 
collaborator: 
has dmc: Yes
This study seeks to study the effectiveness of a short mindfulness based pulmonary
      rehabilitation program prior to a surgical resection in patients with lung cancer and severe
      Chronic Obstructive Lung Disease (COPD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Measure of length of hospital stay post surgical resection of lung cancer in patients that underwent a resection for lung cancer.
time frame: baseline to release from hospital - approx 10 days
description: The length of hospital stay will be compared between participants that under went 10 Mindful Rehabilitation Sessions with participants who received the usual care prior to a lung resection.
measure: Measure post-operative complications in patients that under went 10 session of Mindful Pulmonary Rehabilitation prior to lung resection compared to patients who received usual care prior to a lung resection for lung cancer.
time frame: Post surgerybaseline to release from hospital - approx 10 days
description: The study will compare the number of ICU days, ventilation hours, number of days with a chest tube, subsequent pneumonia or respiratory failure in patients that underwent 10 Mindful Pulmonary Rehabilitation sessions prior to a lung resection to patients who received the usual care prior to a lung resection for lung cancer.
arm group label: Intervention
arm group type: Active Comparator
description: The Intervention Arm will receive 10 sessions of Mindfulness Based Pulmonary Rehabilitation prior to lung surgery
arm group label: Usual Care
arm group type: Placebo Comparator
description: The Usual Care Arm will receive the normal care that a patient with severe COPD having a lung surgery would receive.
intervention type: Behavioral
intervention name: Mindfulness Based Pulmonary Rehabilitation
description: Participants in this group will under go 10 sessions of mindfulness based pulmonary rehabilitation prior to surgery. Each session is about 2 hours long and consists of upper /lower extremity training, breathing exercises, and education.
arm group label: Intervention
intervention type: Other
intervention name: Usual Care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
last name: Roberto P Benzo, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Roberto P. Benzo
investigator title: Principle Investigator
mesh term: Lung Neoplasms
mesh term: Lung Diseases
mesh term: Pulmonary Emphysema
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Emphysema
sharing ipd: No