<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/NCT03234933</url>
  </required_header>
  <id_info>
    <org_study_id>17-152</org_study_id>
    <nct_id>NCT03234933</nct_id>
  </id_info>
  <brief_title>Post-Operative Ambulatory Challenge and Exercise (PACE) Trial</brief_title>
  <official_title>Post-Operative Ambulatory Challenge and Exercise (PACE) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</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 research study is evaluating the postoperative results in terms of quality of life and&#xD;
      functional recovery of elderly patients after cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study, designed to collect data on steps walked (ambulation) per day of&#xD;
      lobectomy patients after surgery. While the investigators know ambulation improves outcomes&#xD;
      after surgery, there is no institutional policy, set of patient goals, or method for deciding&#xD;
      which patients require further resources, such as physical therapy. Data collected will be&#xD;
      used to set up a hospital-wide strategy for patients to achieve post-operative ambulation&#xD;
      milestones more readily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Steps Taken</measure>
    <time_frame>2 years</time_frame>
    <description>Number of steps taken by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance walked</measure>
    <time_frame>2 years</time_frame>
    <description>The distance walked by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Calories Burned</measure>
    <time_frame>2 years</time_frame>
    <description>The number of calories burned by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Mobility Tracker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will be provided by the research team staff with a new mobility tracker&#xD;
The standard pre-operative assessment, surgical procedure and post-operative care will still be done&#xD;
Measurements of each patient (steps, distance and calories) will be obtained by the research staff</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobility Tracker</intervention_name>
    <description>Tracking Patient's movements and calories</description>
    <arm_group_label>Mobility Tracker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients Aged ≥ 18 years&#xD;
&#xD;
          -  Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)&#xD;
&#xD;
          -  With diagnosis of malignant or benign disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with baseline immobility (i.e. wheelchair-bound, use of any walking&#xD;
             assistance device, or gait alterations)&#xD;
&#xD;
          -  Patients with cognitive deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael T Jaklitsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Michael T. Jaklitsch</investigator_full_name>
    <investigator_title>Michael Jaklitsch, MD</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <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/NCT03234933
org study id: 17-152
nct id: NCT03234933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is evaluating the postoperative results in terms of quality of life and
      functional recovery of elderly patients after cancer surgery.
This is a pilot study, designed to collect data on steps walked (ambulation) per day of
      lobectomy patients after surgery. While the investigators know ambulation improves outcomes
      after surgery, there is no institutional policy, set of patient goals, or method for deciding
      which patients require further resources, such as physical therapy. Data collected will be
      used to set up a hospital-wide strategy for patients to achieve post-operative ambulation
      milestones more readily.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Steps Taken
time frame: 2 years
description: Number of steps taken by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.
measure: Distance walked
time frame: 2 years
description: The distance walked by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.
measure: Number of Calories Burned
time frame: 2 years
description: The number of calories burned by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.
arm group label: Mobility Tracker
arm group type: Experimental
description: Each patient will be provided by the research team staff with a new mobility tracker
The standard pre-operative assessment, surgical procedure and post-operative care will still be done
Measurements of each patient (steps, distance and calories) will be obtained by the research staff
intervention type: Other
intervention name: Mobility Tracker
description: Tracking Patient's movements and calories
arm group label: Mobility Tracker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael T Jaklitsch, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Michael T. Jaklitsch
investigator title: Michael Jaklitsch, MD
sharing ipd: No