<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/NCT01729689</url>
  </required_header>
  <id_info>
    <org_study_id>LUN0053</org_study_id>
    <secondary_id>NCI-2012-02096</secondary_id>
    <secondary_id>25339</secondary_id>
    <nct_id>NCT01729689</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers</brief_title>
  <official_title>Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in&#xD;
      patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral&#xD;
      therapy may reduce anxiety and improve the well-being and quality of life of patients who&#xD;
      have stage IV non-small cell lung cancer and their caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To identify, through both quantitative and qualitative methods, clinical correlates of&#xD;
      anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer&#xD;
      and their primary caregivers.&#xD;
&#xD;
      II. To apply these findings to develop a brief dyadic intervention based on Cognitive&#xD;
      Behavioral Therapy (CBT) to reduce anxiety in late-stage lung cancer patients and their&#xD;
      primary caregivers.&#xD;
&#xD;
      III. To evaluate the feasibility and acceptability of the pilot intervention through number&#xD;
      of completed visits and assessment pre- and post- intervention.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6&#xD;
      sessions. Sessions are tailored to patient and caregiver cognitions and approach and&#xD;
      avoidance behaviors.&#xD;
&#xD;
      After completion of study treatment, participants are followed up at 1 week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery</measure>
    <time_frame>Up to 7 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability, based on qualitative analysis of exit interviews</measure>
    <time_frame>Up to 7 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Anxiety Disorder</condition>
  <condition>Recurrent Non-small Cell Lung Cancer</condition>
  <condition>Stage IV Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Supportive care (cognitive behavioral therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>counseling intervention</intervention_name>
    <description>Undergo cognitive behavioral therapy</description>
    <arm_group_label>Supportive care (cognitive behavioral therapy)</arm_group_label>
    <other_name>counseling and communications studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (cognitive behavioral therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (cognitive behavioral therapy)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stage IV non-small cell lung cancer&#xD;
&#xD;
          -  At least 6 weeks post-diagnosis&#xD;
&#xD;
          -  Current symptoms of anxiety (e.g., Hamilton Rating Scale for Anxiety [HAM-A] &gt;=14)&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
          -  CAREGIVER: Identified by patient as primary caregiver&#xD;
&#xD;
          -  CAREGIVER: At least 14 hours/week spent caring for patient&#xD;
&#xD;
          -  CAREGIVER: Current symptoms of anxiety (e.g., HAM-A &gt;= 14)&#xD;
&#xD;
          -  CAREGIVER: Ability to understand and the willingness to sign a written informed&#xD;
             consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PATIENTS AND CAREGIVERS:&#xD;
&#xD;
          -  Active, unstable, untreated serious mental illness&#xD;
&#xD;
          -  Other cognitive inability to complete informed consent process or study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Hendriksen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Ellen Hendriksen</investigator_full_name>
    <investigator_title>Instructor, Psychiatry &amp; Behavioral Science - Behavioral Medicine</investigator_title>
  </responsible_party>
  <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>Anxiety Disorders</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/NCT01729689
org study id: LUN0053
secondary id: NCI-2012-02096
secondary id: 25339
nct id: NCT01729689
lead sponsor: 
collaborator: 
This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in
      patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral
      therapy may reduce anxiety and improve the well-being and quality of life of patients who
      have stage IV non-small cell lung cancer and their caregivers.
PRIMARY OBJECTIVES:

      I. To identify, through both quantitative and qualitative methods, clinical correlates of
      anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer
      and their primary caregivers.

      II. To apply these findings to develop a brief dyadic intervention based on Cognitive
      Behavioral Therapy (CBT) to reduce anxiety in late-stage lung cancer patients and their
      primary caregivers.

      III. To evaluate the feasibility and acceptability of the pilot intervention through number
      of completed visits and assessment pre- and post- intervention.

      OUTLINE:

      Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6
      sessions. Sessions are tailored to patient and caregiver cognitions and approach and
      avoidance behaviors.

      After completion of study treatment, participants are followed up at 1 week.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
time frame: Up to 7 weeks
measure: Acceptability, based on qualitative analysis of exit interviews
time frame: Up to 7 weeks
arm group label: Supportive care (cognitive behavioral therapy)
arm group type: Experimental
description: Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.
intervention type: Other
intervention name: counseling intervention
description: Undergo cognitive behavioral therapy
arm group label: Supportive care (cognitive behavioral therapy)
other name: counseling and communications studies
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Supportive care (cognitive behavioral therapy)
intervention type: Procedure
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Supportive care (cognitive behavioral therapy)
other name: quality of life assessment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ellen Hendriksen
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Ellen Hendriksen
investigator title: Instructor, Psychiatry & Behavioral Science - Behavioral Medicine
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Anxiety Disorders