<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/NCT03285633</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00080262</org_study_id>
    <nct_id>NCT03285633</nct_id>
  </id_info>
  <brief_title>Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer</brief_title>
  <official_title>Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palliative Care Research Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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 study examines the feasibility and acceptability of an open trial of mindfulness-based&#xD;
      Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and&#xD;
      older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited&#xD;
      via letter from their oncologist at community-based clinics (N=18) and those served at the&#xD;
      Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed&#xD;
      consent, participants will be asked to complete assessments (e..g., examining their pain,&#xD;
      anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4&#xD;
      weekly 50-minute telephone sessions with a study therapist and practice skills learned in&#xD;
      session at home. After completing the 4 sessions, they will complete a post-treatment&#xD;
      assessment. Data analyses will examine the feasibility and acceptability of the study by&#xD;
      assessing participant engagement, and will examine changes in key psychological variables&#xD;
      (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to&#xD;
      post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with advanced cancers often experience significant symptom burden including pain,&#xD;
      fatigue, and psychological distress, all while facing acceptance of the meaning of their&#xD;
      advanced disease. Evidence-based behavioral interventions have been developed to alleviate&#xD;
      this multiple symptom burden but are understudied and the treatments that are available are&#xD;
      often not easily accessed by patients most in need in community-based settings. The current&#xD;
      study examines the feasibility and acceptability of an open trial of mindfulness-based&#xD;
      Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and&#xD;
      older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited&#xD;
      via letter from their oncologist at community-based clinics (N=18) and those served at the&#xD;
      Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed&#xD;
      consent, participants will be asked to complete assessments (e..g., examining their pain,&#xD;
      anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4&#xD;
      weekly 50-minute telephone sessions with a study therapist and practice skills learned in&#xD;
      session at home. After completing the 4 sessions, they will complete a post-treatment&#xD;
      assessment. Data analyses will examine the feasibility and acceptability of the study by&#xD;
      assessing participant engagement, and will examine changes in key psychological variables&#xD;
      (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to&#xD;
      post-treatment. There is minimal risk related to confidentiality of data and the possibility&#xD;
      of feeling uncomfortable in the study. All study contacts will be conducted by trained study&#xD;
      staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data&#xD;
      will be stored online via REDCAP and accessed only by study staff, participant assessment&#xD;
      data will be collected and stored online via REDCap, and audio recordings of study telephone&#xD;
      sessions will be stored on Duke servers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">September 8, 2018</completion_date>
  <primary_completion_date type="Actual">September 8, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Feasibility will be shown by no more than 20% study attrition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability, as measured by Client Satisfaction Questionnaire 10-item version</measure>
    <time_frame>8 weeks</time_frame>
    <description>Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as measured by study accrual by meeting recruitment goal</measure>
    <time_frame>8 weeks</time_frame>
    <description>Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant</measure>
    <time_frame>8 weeks</time_frame>
    <description>Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Pain will be assessed with the Brief Pain Inventory (BPI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mindfulness</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Acceptance</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Mutli-Symptom management(CBT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Mutli-Symptom management(CBT)</intervention_name>
    <description>Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.</description>
    <arm_group_label>Cognitive Behavioral Mutli-Symptom management(CBT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being at least 21 years of age&#xD;
&#xD;
          -  a diagnosis of stage IV cancer in the past 3 years&#xD;
&#xD;
          -  being able to speak/read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  visual or hearing impairment that would prevent ability to engage in the telephone&#xD;
             session or study materials&#xD;
&#xD;
          -  presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or&#xD;
             episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate&#xD;
             safe participation in the study as indicated by the medical chart, treating&#xD;
             oncologist, or interactions with the medical/study staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Plumb Vilardaga</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</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>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/NCT03285633
org study id: Pro00080262
nct id: NCT03285633
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the feasibility and acceptability of an open trial of mindfulness-based
      Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and
      older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited
      via letter from their oncologist at community-based clinics (N=18) and those served at the
      Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed
      consent, participants will be asked to complete assessments (e..g., examining their pain,
      anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4
      weekly 50-minute telephone sessions with a study therapist and practice skills learned in
      session at home. After completing the 4 sessions, they will complete a post-treatment
      assessment. Data analyses will examine the feasibility and acceptability of the study by
      assessing participant engagement, and will examine changes in key psychological variables
      (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to
      post-treatment.
Individuals with advanced cancers often experience significant symptom burden including pain,
      fatigue, and psychological distress, all while facing acceptance of the meaning of their
      advanced disease. Evidence-based behavioral interventions have been developed to alleviate
      this multiple symptom burden but are understudied and the treatments that are available are
      often not easily accessed by patients most in need in community-based settings. The current
      study examines the feasibility and acceptability of an open trial of mindfulness-based
      Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and
      older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited
      via letter from their oncologist at community-based clinics (N=18) and those served at the
      Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed
      consent, participants will be asked to complete assessments (e..g., examining their pain,
      anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4
      weekly 50-minute telephone sessions with a study therapist and practice skills learned in
      session at home. After completing the 4 sessions, they will complete a post-treatment
      assessment. Data analyses will examine the feasibility and acceptability of the study by
      assessing participant engagement, and will examine changes in key psychological variables
      (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to
      post-treatment. There is minimal risk related to confidentiality of data and the possibility
      of feeling uncomfortable in the study. All study contacts will be conducted by trained study
      staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data
      will be stored online via REDCAP and accessed only by study staff, participant assessment
      data will be collected and stored online via REDCap, and audio recordings of study telephone
      sessions will be stored on Duke servers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
time frame: 8 weeks
description: Feasibility will be shown by no more than 20% study attrition.
measure: Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
time frame: 8 weeks
description: Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
measure: Feasibility as measured by study accrual by meeting recruitment goal
time frame: 8 weeks
description: Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.
measure: Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
time frame: 8 weeks
description: Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
measure: Change in pain
time frame: Baseline and 8 weeks
description: Pain will be assessed with the Brief Pain Inventory (BPI)
measure: Change in fatigue
time frame: Baseline and 8 weeks
description: Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
measure: Change in depression
time frame: Baseline and 8 weeks
description: The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
measure: Change in Mindfulness
time frame: Baseline and 8 weeks
description: Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.
measure: Change in anxiety
time frame: Baseline and 8 weeks
description: The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
measure: Change in Acceptance
time frame: Baseline and 8 weeks
description: Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.
arm group label: Cognitive Behavioral Mutli-Symptom management(CBT)
arm group type: Other
description: Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.
intervention type: Behavioral
intervention name: Cognitive Behavioral Mutli-Symptom management(CBT)
description: Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
arm group label: Cognitive Behavioral Mutli-Symptom management(CBT)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Plumb Vilardaga
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms