<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/NCT03773380</url>
  </required_header>
  <id_info>
    <org_study_id>SJHH-BA</org_study_id>
    <nct_id>NCT03773380</nct_id>
  </id_info>
  <brief_title>Breathe Anew for Lung Cancer Survivorship</brief_title>
  <acronym>BA</acronym>
  <official_title>Breathe Anew: Designing and Testing the Feasibility of a Novel Intervention for Lung Cancer Survivorship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Survivorship programs have become an integral component of modern cancer care programs. In&#xD;
      Canada, there has been tremendous success for survivorship programs for breast, prostate, and&#xD;
      colorectal cancer, however lung cancer survivorship programs have not been widely developed.&#xD;
      The complexity of the disease, high mortality, short survival times, high cost of&#xD;
      surveillance, and patient habits have traditionally been barriers against the success of lung&#xD;
      cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel&#xD;
      intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the&#xD;
      design and implementation of a lung cancer survivorship program. The investigator has&#xD;
      assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the&#xD;
      Breathe Anew survivorship intervention. The intervention will be vetted using an integrated&#xD;
      knowledge translation approach, which will involve members of the target population,&#xD;
      primarily patients who previously underwent lung resection, to modify the intervention and&#xD;
      ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot&#xD;
      study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of&#xD;
      this feasibility study is to lay the groundwork for a subsequent comparative trial to&#xD;
      evaluate the impact of Breathe Anew on patient-important outcomes including health related&#xD;
      quality and length of life and postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>12 months</time_frame>
    <description>The feasibility of Breath Anew, as measured by a rate of compliance of &gt;70% with all the components of the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accrual Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of accrual to the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>Using the EQ-5D-5L, which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L asks the participant to indicate what best describes their health on the day the scale is administered and it consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression which are measured by a severity scale from 1-5 (no problems = 1, slight problems = 2, moderate problems = 3, severe problems = 4, or completely unable to = 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Per Patient</measure>
    <time_frame>12 months</time_frame>
    <description>Cost per patient for the duration of the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Feasibility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 patients will be recruited to take part in this feasibility study. They will all undergo this Breathe Anew Program post-surgery. Breathe Anew consists of radiological surveillance, physical rehabilitation using a Fitbit, mindfulness therapy, and referral for symptom management specialists when needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Breathe Anew Survivorship Program</intervention_name>
    <description>The feasibility will be tested of the Breathe Anew Survivorship Program</description>
    <arm_group_label>Feasibility</arm_group_label>
    <other_name>Wearable Technology, Mindfulness Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  All patients at St. Joseph's Healthcare Hamilton who received lung resection for Stage&#xD;
             I, Stage II, or Stage IIIa Non-Small Cell Lung Cancer are eligible to enroll.&#xD;
&#xD;
          -  Owns a smart device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received lung resection for Stage IIIb or IV Non-Small Cell Lung Cancer&#xD;
&#xD;
          -  Patients with affected mobility (walker, wheelchair)&#xD;
&#xD;
          -  Patients who use oxygen at home&#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>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Wael Hanna</investigator_full_name>
    <investigator_title>Associate Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03773380
org study id: SJHH-BA
nct id: NCT03773380
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Survivorship programs have become an integral component of modern cancer care programs. In
      Canada, there has been tremendous success for survivorship programs for breast, prostate, and
      colorectal cancer, however lung cancer survivorship programs have not been widely developed.
      The complexity of the disease, high mortality, short survival times, high cost of
      surveillance, and patient habits have traditionally been barriers against the success of lung
      cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel
      intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the
      design and implementation of a lung cancer survivorship program. The investigator has
      assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the
      Breathe Anew survivorship intervention. The intervention will be vetted using an integrated
      knowledge translation approach, which will involve members of the target population,
      primarily patients who previously underwent lung resection, to modify the intervention and
      ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot
      study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of
      this feasibility study is to lay the groundwork for a subsequent comparative trial to
      evaluate the impact of Breathe Anew on patient-important outcomes including health related
      quality and length of life and postoperative complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Compliance
time frame: 12 months
description: The feasibility of Breath Anew, as measured by a rate of compliance of >70% with all the components of the intervention.
measure: Accrual Rate
time frame: 12 months
description: Rate of accrual to the intervention
measure: Patient-Reported Satisfaction
time frame: 12 months
description: Using the EQ-5D-5L, which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The EQ-5D-5L asks the participant to indicate what best describes their health on the day the scale is administered and it consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression which are measured by a severity scale from 1-5 (no problems = 1, slight problems = 2, moderate problems = 3, severe problems = 4, or completely unable to = 5).
measure: Cost Per Patient
time frame: 12 months
description: Cost per patient for the duration of the intervention
arm group label: Feasibility
arm group type: Experimental
description: 50 patients will be recruited to take part in this feasibility study. They will all undergo this Breathe Anew Program post-surgery. Breathe Anew consists of radiological surveillance, physical rehabilitation using a Fitbit, mindfulness therapy, and referral for symptom management specialists when needed.
intervention type: Combination Product
intervention name: Breathe Anew Survivorship Program
description: The feasibility will be tested of the Breathe Anew Survivorship Program
arm group label: Feasibility
other name: Wearable Technology, Mindfulness Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Wael Hanna
investigator title: Associate Professor of Surgery
mesh term: Lung Neoplasms