<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/NCT03750864</url>
  </required_header>
  <id_info>
    <org_study_id>29927</org_study_id>
    <nct_id>NCT03750864</nct_id>
  </id_info>
  <brief_title>Innovative Approach to Reduce Lung Cancer Stigma</brief_title>
  <official_title>An Innovative Approach to Reduce Lung Cancer Stigma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</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 is a feasibility study examining the feasibility and acceptability of a novel&#xD;
      psychotherapy intervention on lung cancer patients who are experiencing stigma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experiences of stigma (perception and internalization of negative appraisal and devaluation&#xD;
      from others) are pervasive for lung cancer patients. Previous work has shown associations&#xD;
      between lung cancer stigma and detriments in clinically relevant outcomes such as depression,&#xD;
      lower quality of life, and reduced engagement in cancer care.&#xD;
&#xD;
      The investigators previously developed Acceptance and Commitment Therapy for Lung Cancer&#xD;
      Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and&#xD;
      inhibited disclosure associated with lung cancer stigma. ACT-LCS is based in Acceptance and&#xD;
      Commitment Therapy (ACT), a cognitive-behavioral treatment that promotes psychological&#xD;
      flexibility through acceptance and valued direction.&#xD;
&#xD;
      This is a feasibility study examining the feasibility and acceptability of ACT-LCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2018</start_date>
  <completion_date type="Actual">July 13, 2020</completion_date>
  <primary_completion_date type="Actual">July 13, 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 individuals who consent to the intervention</measure>
    <time_frame>10 months</time_frame>
    <description>This measure will be calculated as a function of those eligible and approached who consented to the intervention. It will be utilized as a metric of feasibility and acceptability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of sessions that each consented patient attended</measure>
    <time_frame>10 months</time_frame>
    <description>This measure will be calculated as a count of sessions that each consented participant attended. It will be utilized as a metric of acceptability of the intervention among consented participants.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Lung Cancer Stigma</condition>
  <condition>Lung Cancer</condition>
  <condition>Stigma, Social</condition>
  <condition>Stigmatization</condition>
  <condition>Acceptance Processes</condition>
  <arm_group>
    <arm_group_label>ACT-LCS Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is psychosocial counseling utilizing Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACT-LCS Therapy</intervention_name>
    <description>All participants in Stage 1, and those randomized to the intervention condition in Stage 2, will receive the Acceptance &amp; Commitment Therapy for Lung Cancer Stigma (ACT-LCS) intervention. The ACT-LC intervention is designed to be delivered as 6 sessions of individual psychotherapy with a trained psychotherapist at a weekly or bimonthly rate, delivered either in person or over the phone. The treatment manual is based in Acceptance and Commitment Therapy (ACT). Therapists are instructed to begin treatment with Module 1. Modules 2-5 can then be administered in any order at the discretion of the therapist, based upon what the therapist thinks is most likely to be helpful to the patient. Module 6 is the final session of treatment.</description>
    <arm_group_label>ACT-LCS Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Proficiency in English&#xD;
&#xD;
          -  Diagnosed with or treated for Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung&#xD;
             Cancer (SCLC) within the prior 12 months.&#xD;
&#xD;
          -  Scores of 37.5 on the Lung Cancer Stigma Inventory (LCSI) screening measure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not proficient in English&#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>Heidi Hamann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Garland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>Stigma</keyword>
  <keyword>Lung cancer stigma</keyword>
  <keyword>Acceptance and commitment therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03750864
org study id: 29927
nct id: NCT03750864
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a feasibility study examining the feasibility and acceptability of a novel
      psychotherapy intervention on lung cancer patients who are experiencing stigma.
Experiences of stigma (perception and internalization of negative appraisal and devaluation
      from others) are pervasive for lung cancer patients. Previous work has shown associations
      between lung cancer stigma and detriments in clinically relevant outcomes such as depression,
      lower quality of life, and reduced engagement in cancer care.

      The investigators previously developed Acceptance and Commitment Therapy for Lung Cancer
      Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and
      inhibited disclosure associated with lung cancer stigma. ACT-LCS is based in Acceptance and
      Commitment Therapy (ACT), a cognitive-behavioral treatment that promotes psychological
      flexibility through acceptance and valued direction.

      This is a feasibility study examining the feasibility and acceptability of ACT-LCS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of individuals who consent to the intervention
time frame: 10 months
description: This measure will be calculated as a function of those eligible and approached who consented to the intervention. It will be utilized as a metric of feasibility and acceptability.
measure: Number of sessions that each consented patient attended
time frame: 10 months
description: This measure will be calculated as a count of sessions that each consented participant attended. It will be utilized as a metric of acceptability of the intervention among consented participants.
arm group label: ACT-LCS Therapy
arm group type: Experimental
description: Intervention is psychosocial counseling utilizing Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma.
intervention type: Behavioral
intervention name: ACT-LCS Therapy
description: All participants in Stage 1, and those randomized to the intervention condition in Stage 2, will receive the Acceptance & Commitment Therapy for Lung Cancer Stigma (ACT-LCS) intervention. The ACT-LC intervention is designed to be delivered as 6 sessions of individual psychotherapy with a trained psychotherapist at a weekly or bimonthly rate, delivered either in person or over the phone. The treatment manual is based in Acceptance and Commitment Therapy (ACT). Therapists are instructed to begin treatment with Module 1. Modules 2-5 can then be administered in any order at the discretion of the therapist, based upon what the therapist thinks is most likely to be helpful to the patient. Module 6 is the final session of treatment.
arm group label: ACT-LCS Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heidi Hamann, PhD
role: Principal Investigator
affiliation: University of Arizona
last name: Linda Garland, MD
role: Principal Investigator
affiliation: University of Arizona
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No