xml: <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/NCT05984680</url>
    </required_header>
    <id_info>
      <org_study_id>WFBCCC 99723</org_study_id>
      <secondary_id>P30CA012197</secondary_id>
      <nct_id>NCT05984680</nct_id>
    </id_info>
    <brief_title>COPD Care Pathway Among Patients With Cancer</brief_title>
    <official_title>Mixed-Methods Implementation of a COPD Care Pathway Among Patients With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</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>
        The research objective for this pilot study is to design the first care pathway to implement&#xD;
        COPD care in a community oncology clinic. Using a mixed-methods user-centered design process,&#xD;
        investigators will ensure the feasibility of evidence-based practices in this setting.&#xD;
  &#xD;
        The results of this pilot study will directly inform a randomized controlled trial to measure&#xD;
        whether COPD control reduces hospitalization risk.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective: To measure feasibility of a novel chronic obstructive pulmonary disease&#xD;
        (COPD) care pathway in an oncology clinic.&#xD;
  &#xD;
        Secondary Objective(s)&#xD;
  &#xD;
          -  To assess barriers to implementing of a COPD intervention for community oncology clinics&#xD;
             using surveys and interviews of patients and providers.&#xD;
  &#xD;
          -  To measure acceptability of a novel COPD care pathway in an oncology clinic.&#xD;
  &#xD;
          -  To measure appropriateness of a novel COPD care pathway in an oncology clinic.&#xD;
  &#xD;
          -  To measure organizational readiness of a novel COPD care pathway in an oncology clinic.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>There are two aims to this trial. Arm A is for participants and providers with study intervention consisting of surveys/interviews and an assessment to design a COPD care pathway for implementation in community oncology clinics, evaluated in Arm B.&#xD;
  Aim B is for participants only to evaluate feasibility of COPD care pathway in oncology clinics.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants that Agree the COPD Pathway is Feasible - Feasibility Implementation Measure (FIM)</measure>
      <time_frame>6 months</time_frame>
      <description>Using a four-item questionnaire designed to measure perceived feasibility of COPD care pathway using a Likert scale from 1-5 (1 = &quot;completely disagree,&quot; 5 = &quot;completely agree&quot;) with a mean item score of ≥3 (&quot;neither agree nor disagree&quot;), (score range range minimum score of 4 to maximum score of 20 ) among answered items defined as higher scores indicating a positive outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Barriers Identified to the Implementation of a COPD Intervention for Community Oncology Clinics</measure>
      <time_frame>14 months</time_frame>
      <description>Using surveys and qualitative interviews conducted with a purposive sample of oncology patients and providers to identify the barriers to implementation present in some clinics but not others.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants to Find the COPD Care Pathway Acceptable - Acceptability Implementation Measure (AIM).</measure>
      <time_frame>14 months</time_frame>
      <description>Using a four-item questionnaire designed to measure the perceived acceptability of the COPD care pathway using a Likert scale from 1-5 (1 = &quot;completely disagree,&quot; 5 = &quot;completely agree&quot;) with a mean item score of ≥3 (&quot;neither agree nor disagree&quot;) among answered items defined as a positive outcome. Minimum score of 4, maximum score of 20. Higher scores indicated a more positive outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants to Find the COPD Care Pathway Appropriate - Appropriateness Implementation Measure (AIM).</measure>
      <time_frame>14 months</time_frame>
      <description>Using a four-item questionnaire designed to measure the perceived acceptability of the COPD care pathway using a Likert scale from 1-5 (1 = &quot;completely disagree,&quot; 5 = &quot;completely agree&quot;) with a mean item score of ≥3 (&quot;neither agree nor disagree&quot;) among answered items defined as a positive outcome. Minimum score of 4, maximum score of 20. Higher scores indicated a more positive outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Clinics Ready to Adopt the COPD Care Pathway - Organizational Readiness for Implementing Change (ORIC)</measure>
      <time_frame>14 months</time_frame>
      <description>Organizational readiness for implementing change to optimize COPD care among oncology providers in an oncology clinic with the validated 12-item Organizational Readiness for Implementing Change (ORIC). Each of the 12 ORIC items use a Likert scale from 1-5 (1 = &quot;disagree,&quot; 5 = &quot;agree&quot;) with a mean item score of ≥3 (&quot;neither agree nor disagree&quot;) among answered items defined as a positive outcome. Minimum score of 12, maximum score of 60. Higher scores indicated a more positive outcome. Investigators will use a baseline adjusted model to assess pre-post change scores in organizational readiness (ORIC) to adopt the COPD 2 pathway.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <condition>Lung Cancer</condition>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>Aim A - Participants and Providers</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Arm A will use the user-centered design process to survey pulmonology content experts, oncology providers, and patients and interview a smaller subset. Specifically, we will measure the perceived efficacy of various components of COPD management using a survey of patients with thoracic cancer and oncology providers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B - Participants only COPD Care Pathway</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Investigators will use the COPD care pathway developed by Arm A as the intervention in single-arm pilot study to test its feasibility and other implementation outcomes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Surveys and Interviews - Arm A</intervention_name>
      <description>For Arm A, this outpatient study will administer surveys, interviews, concept mapping exercises, guided tours of oncology clinics, design team workshops, and phone calls for follow-up questions</description>
      <arm_group_label>Aim A - Participants and Providers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>COPD Care Pathway</intervention_name>
      <description>The COPD care pathway will consist of an initial assessment followed by monthly follow-up assessments, which occur during regularly scheduled immunotherapy infusions. At each of these three visits, the study team will administer symptom measures, counsel participants on the management of COPD, and give algorithm-generated general recommendations to the patient and provider regarding possible options for COPD-directed care.</description>
      <arm_group_label>Arm B - Participants only COPD Care Pathway</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria (Arm A only):&#xD;
  &#xD;
            -  The participant meets one of the following criteria: (a) a patient known or suspected&#xD;
               to have COPD and currently or have ever previously received immunotherapy for any type&#xD;
               of cancer (b) a provider who currently works at least part time in a medical oncology&#xD;
               clinic, or (c) a provider who currently works at least part time providing care for&#xD;
               patients with known or suspected COPD. In the context of this study, a provider is&#xD;
               defined as a physician, advanced practice provider, nurse, or respiratory therapist.&#xD;
  &#xD;
            -  Ability to understand and be willing to sign an IRB-approved informed consent document&#xD;
               directly.&#xD;
  &#xD;
          Exclusion Criteria (Arm A only)&#xD;
  &#xD;
          - Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
          infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
          arrhythmia, or psychiatric illness/social situations that would limit adherence to study&#xD;
          requirements.&#xD;
  &#xD;
          Inclusion Criteria (Arm B only)&#xD;
  &#xD;
            -  Radiographic evidence or suspected symptoms of COPD (e.g. wheezing, coughing, chest&#xD;
               tightness, dyspnea).&#xD;
  &#xD;
            -  A documented diagnosis of cancer from a primary site either in the lung (any type or&#xD;
               subtype) or head/neck (mucosal squamous subtype only).&#xD;
  &#xD;
            -  Treatment with one or more immune checkpoint inhibitor that is either (a) planned to&#xD;
               start within the next six weeks, or (b) has already been started within the last six&#xD;
               weeks.&#xD;
  &#xD;
            -  Eighteen years old or greater. Given the rare co-occurrence of respiratory tract&#xD;
               cancer and COPD in the pediatric patient population, their inclusion would make&#xD;
               interpretation of data difficult.&#xD;
  &#xD;
            -  ECOG performance status of 0-2.&#xD;
  &#xD;
            -  Life expectancy of greater than three months.&#xD;
  &#xD;
            -  Ability to understand and be willing to sign an IRB-approved informed consent document&#xD;
               directly.&#xD;
  &#xD;
          Exclusion Criteria (Arm B only)&#xD;
  &#xD;
            -  Active autoimmune disease requiring systemic immunosuppression at the time of&#xD;
               enrollment.&#xD;
  &#xD;
            -  History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent&#xD;
               prednisone &gt;20 mg/day for more than one week).&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic&#xD;
               congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric&#xD;
               illness/social situations that would limit compliance with study requirements.&#xD;
  &#xD;
            -  Patients who are pregnant or breastfeeding.&#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>Thomas Lycan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest Baptist Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Research Participant Coordinator</last_name>
      <phone>336-716-6700</phone>
      <email>btopalog@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wake Forest Baptist Comprehensive Cancer Center</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Research Participant Coordinator</last_name>
      </contact>
      <contact_backup>
        <phone>336-716-6700</phone>
      </contact_backup>
      <investigator>
        <last_name>Thomas Lycan, Jr, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984680
  org study id: WFBCCC 99723
  secondary id: P30CA012197
  nct id: NCT05984680
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The research objective for this pilot study is to design the first care pathway to implement
        COPD care in a community oncology clinic. Using a mixed-methods user-centered design process,
        investigators will ensure the feasibility of evidence-based practices in this setting.
  
        The results of this pilot study will directly inform a randomized controlled trial to measure
        whether COPD control reduces hospitalization risk.
  Primary Objective: To measure feasibility of a novel chronic obstructive pulmonary disease
        (COPD) care pathway in an oncology clinic.
  
        Secondary Objective(s)
  
          -  To assess barriers to implementing of a COPD intervention for community oncology clinics
             using surveys and interviews of patients and providers.
  
          -  To measure acceptability of a novel COPD care pathway in an oncology clinic.
  
          -  To measure appropriateness of a novel COPD care pathway in an oncology clinic.
  
          -  To measure organizational readiness of a novel COPD care pathway in an oncology clinic.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: There are two aims to this trial. Arm A is for participants and providers with study intervention consisting of surveys/interviews and an assessment to design a COPD care pathway for implementation in community oncology clinics, evaluated in Arm B.
  Aim B is for participants only to evaluate feasibility of COPD care pathway in oncology clinics.
  primary purpose: Other
  masking: None (Open Label)
  measure: Number of Participants that Agree the COPD Pathway is Feasible - Feasibility Implementation Measure (FIM)
  time frame: 6 months
  description: Using a four-item questionnaire designed to measure perceived feasibility of COPD care pathway using a Likert scale from 1-5 (1 = "completely disagree," 5 = "completely agree") with a mean item score of ≥3 ("neither agree nor disagree"), (score range range minimum score of 4 to maximum score of 20 ) among answered items defined as higher scores indicating a positive outcome.
  measure: Number of Barriers Identified to the Implementation of a COPD Intervention for Community Oncology Clinics
  time frame: 14 months
  description: Using surveys and qualitative interviews conducted with a purposive sample of oncology patients and providers to identify the barriers to implementation present in some clinics but not others.
  measure: Number of Participants to Find the COPD Care Pathway Acceptable - Acceptability Implementation Measure (AIM).
  time frame: 14 months
  description: Using a four-item questionnaire designed to measure the perceived acceptability of the COPD care pathway using a Likert scale from 1-5 (1 = "completely disagree," 5 = "completely agree") with a mean item score of ≥3 ("neither agree nor disagree") among answered items defined as a positive outcome. Minimum score of 4, maximum score of 20. Higher scores indicated a more positive outcome.
  measure: Number of Participants to Find the COPD Care Pathway Appropriate - Appropriateness Implementation Measure (AIM).
  time frame: 14 months
  description: Using a four-item questionnaire designed to measure the perceived acceptability of the COPD care pathway using a Likert scale from 1-5 (1 = "completely disagree," 5 = "completely agree") with a mean item score of ≥3 ("neither agree nor disagree") among answered items defined as a positive outcome. Minimum score of 4, maximum score of 20. Higher scores indicated a more positive outcome.
  measure: Number of Clinics Ready to Adopt the COPD Care Pathway - Organizational Readiness for Implementing Change (ORIC)
  time frame: 14 months
  description: Organizational readiness for implementing change to optimize COPD care among oncology providers in an oncology clinic with the validated 12-item Organizational Readiness for Implementing Change (ORIC). Each of the 12 ORIC items use a Likert scale from 1-5 (1 = "disagree," 5 = "agree") with a mean item score of ≥3 ("neither agree nor disagree") among answered items defined as a positive outcome. Minimum score of 12, maximum score of 60. Higher scores indicated a more positive outcome. Investigators will use a baseline adjusted model to assess pre-post change scores in organizational readiness (ORIC) to adopt the COPD 2 pathway.
  arm group label: Aim A - Participants and Providers
  arm group type: Other
  description: Arm A will use the user-centered design process to survey pulmonology content experts, oncology providers, and patients and interview a smaller subset. Specifically, we will measure the perceived efficacy of various components of COPD management using a survey of patients with thoracic cancer and oncology providers.
  arm group label: Arm B - Participants only COPD Care Pathway
  arm group type: Other
  description: Investigators will use the COPD care pathway developed by Arm A as the intervention in single-arm pilot study to test its feasibility and other implementation outcomes.
  intervention type: Other
  intervention name: Surveys and Interviews - Arm A
  description: For Arm A, this outpatient study will administer surveys, interviews, concept mapping exercises, guided tours of oncology clinics, design team workshops, and phone calls for follow-up questions
  arm group label: Aim A - Participants and Providers
  intervention type: Other
  intervention name: COPD Care Pathway
  description: The COPD care pathway will consist of an initial assessment followed by monthly follow-up assessments, which occur during regularly scheduled immunotherapy infusions. At each of these three visits, the study team will administer symptom measures, counsel participants on the management of COPD, and give algorithm-generated general recommendations to the patient and provider regarding possible options for COPD-directed care.
  arm group label: Arm B - Participants only COPD Care Pathway
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas Lycan, MD
  role: Principal Investigator
  affiliation: Wake Forest Baptist Comprehensive Cancer Center
  last name: Research Participant Coordinator
  phone: 336-716-6700
  email: btopalog@wakehealth.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No