<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/NCT04431830</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105953</org_study_id>
    <nct_id>NCT04431830</nct_id>
  </id_info>
  <brief_title>Meaning-Centered Pain Coping Skills Training</brief_title>
  <official_title>Meaning-Centered Pain Coping Skills Training: A Randomized Pilot Trial for Patients With Advanced Cancer and Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</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 is a randomized clinical trial of a psychosocial pain management intervention&#xD;
      called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid&#xD;
      tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control&#xD;
      condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week&#xD;
      follow-ups. The first aim of this study is to assess the feasibility of conducting a&#xD;
      randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on&#xD;
      patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy&#xD;
      for pain management, and psychological distress. The third aim is to describe participants'&#xD;
      experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues&#xD;
      in this trial are low and limited to those common to a psychosocial intervention (e.g., loss&#xD;
      of confidentiality).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients with advanced cancer describe pain as their most feared and distressing&#xD;
      symptom. In this population, higher pain levels often predict worse physical, emotional, and&#xD;
      existential/spiritual well-being. Psychosocial interventions show promise for improving&#xD;
      cancer-related pain; however, no interventions address existential concerns (e.g., a loss of&#xD;
      meaning in life) that are common among those facing pain from advanced illness. To address&#xD;
      this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was&#xD;
      developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain&#xD;
      (e.g., guided imagery) in order to help them engage with what gives their life a sense of&#xD;
      meaning, purpose, and significance.&#xD;
&#xD;
      This pilot study is being conducted to prepare for a large-scale clinical trial that will&#xD;
      test the efficacy of MCPC for improving patients' pain and pain-related outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2021</start_date>
  <completion_date type="Actual">May 3, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to an intervention or a standard care control condition.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as measured by study accrual</measure>
    <time_frame>Baseline</time_frame>
    <description>Treatment feasibility will be evidenced by meeting study accrual (N = 60).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as measured by adherence and assessment completion</measure>
    <time_frame>5-week follow-up (immediately post-intervention)</time_frame>
    <description>Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility as measured by attrition</measure>
    <time_frame>5-week follow-up (immediately post-intervention)</time_frame>
    <description>Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain severity</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Pain severity will be measured using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain. The minimum value on this scale is 0 and the maximum value is 10. Higher scores represent worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain interference</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Pain interference will be measured using the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form. This measure assesses the degree to which pain has impacted patients' enjoyment of life and engagement in social, cognitive, emotional, physical, and recreational activities. The minimum value on this scale is 6 and the maximum value is 30. Higher scores represent worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in meaning in life</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp).The minimum value on each subscale is 0 and the maximum value is 4. Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy for pain management</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Self-efficacy for pain management will be measured using the Self-efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale. The subscale includes 5 items assessing patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication.The minimum value on this scale is 10 and the maximum value is 100. Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Anxiety will be measured using the 7-item version of the Generalized Anxiety Disorders scale (GAD-7), which assesses the frequency of nervousness, worry, difficulty relaxing, restlessness, irritability, and fear. The minimum value on this scale is 0 and the maximum value is 21. Higher scores represent worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Depressive symptoms will be measured using the 8-item version of the Patient Health Questionnaire (PHQ-8), which assesses the frequency of anhedonia, depressed mood, sleep difficulties, lack of energy, appetite disturbance, low self-esteem, trouble concentrating, and psychomotor retardation.The minimum value on this scale is 0 and the maximum value is 24. Higher scores represent worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hopelessness</measure>
    <time_frame>Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up</time_frame>
    <description>Hopelessness will be measured using the Hopelessness Assessment in Illness Questionnaire. The scale includes 8 items assessing the degree to which patients have felt hopelessness, discouragement, and dread. The minimum value on this scale is 0 and the maximum value is 16. Higher scores represent worse outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Meaning-Centered Pain Coping Skills Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Information and referrals for free services available through the Duke Cancer Patient Support Program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Meaning-Centered Pain Coping Skills Training</intervention_name>
    <description>The goal of this intervention is to help participants manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.</description>
    <arm_group_label>Meaning-Centered Pain Coping Skills Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer&#xD;
             diagnosis&#xD;
&#xD;
          -  At least moderate pain (worst pain in past week &gt;/= 4 out of 10) at screening&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &lt;/= 2 at screening&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain tumor diagnosis&#xD;
&#xD;
          -  Significant cognitive impairment&#xD;
&#xD;
          -  Untreated serious mental illness that would interfere with engagement in the&#xD;
             interventions (e.g., schizophrenia)&#xD;
&#xD;
          -  Previous engagement in Pain Coping Skills Training or Meaning-Centered Psychotherapy&#xD;
&#xD;
          -  Enrollment in hospice&#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>Joseph G Winger, PhD</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>May 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid Tumor Cancer</keyword>
  <keyword>Pain</keyword>
  <keyword>Meaning-Centered Psychotherapy</keyword>
  <keyword>Pain Coping Skills Training</keyword>
  <keyword>Meaning-Centered Pain Coping</keyword>
  <keyword>Advanced Cancer</keyword>
  <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/NCT04431830
org study id: Pro00105953
nct id: NCT04431830
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized clinical trial of a psychosocial pain management intervention
      called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid
      tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control
      condition. Patient-reported outcomes will be assessed at baseline and 5- and 10-week
      follow-ups. The first aim of this study is to assess the feasibility of conducting a
      randomized clinical trial to test MCPC. The second aim is to characterize MCPC's effects on
      patient-reported outcomes of pain severity, pain interference, meaning in life, self-efficacy
      for pain management, and psychological distress. The third aim is to describe participants'
      experiences of MCPC using semi-structured qualitative interviews. The risk and safety issues
      in this trial are low and limited to those common to a psychosocial intervention (e.g., loss
      of confidentiality).
Many patients with advanced cancer describe pain as their most feared and distressing
      symptom. In this population, higher pain levels often predict worse physical, emotional, and
      existential/spiritual well-being. Psychosocial interventions show promise for improving
      cancer-related pain; however, no interventions address existential concerns (e.g., a loss of
      meaning in life) that are common among those facing pain from advanced illness. To address
      this need, an intervention called Meaning-Centered Pain Coping Skills Training (MCPC) was
      developed. MCPC seeks to teach patients cognitive and behavioral skills for managing pain
      (e.g., guided imagery) in order to help them engage with what gives their life a sense of
      meaning, purpose, and significance.

      This pilot study is being conducted to prepare for a large-scale clinical trial that will
      test the efficacy of MCPC for improving patients' pain and pain-related outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to an intervention or a standard care control condition.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility as measured by study accrual
time frame: Baseline
description: Treatment feasibility will be evidenced by meeting study accrual (N = 60).
measure: Feasibility as measured by adherence and assessment completion
time frame: 5-week follow-up (immediately post-intervention)
description: Treatment feasibility will be evidenced by at least 75% of participants completing all four intervention sessions as well as the 5-week follow-up assessment.
measure: Feasibility as measured by attrition
time frame: 5-week follow-up (immediately post-intervention)
description: Treatment feasibility will be evidenced by no more than 25% attrition by the 5-week follow-up.
measure: Change in pain severity
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Pain severity will be measured using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain. The minimum value on this scale is 0 and the maximum value is 10. Higher scores represent worse outcomes.
measure: Change in pain interference
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Pain interference will be measured using the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form. This measure assesses the degree to which pain has impacted patients' enjoyment of life and engagement in social, cognitive, emotional, physical, and recreational activities. The minimum value on this scale is 6 and the maximum value is 30. Higher scores represent worse outcomes.
measure: Change in meaning in life
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp).The minimum value on each subscale is 0 and the maximum value is 4. Higher scores represent better outcomes.
measure: Change in self-efficacy for pain management
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Self-efficacy for pain management will be measured using the Self-efficacy for Pain Management subscale of the Chronic Pain Self-Efficacy Scale. The subscale includes 5 items assessing patients' confidence regarding pain management, managing pain during daily activities, keeping pain from interfering with sleep, and confidence in their ability to reduce pain using methods other than taking additional medication.The minimum value on this scale is 10 and the maximum value is 100. Higher scores represent better outcomes.
measure: Change in anxiety
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Anxiety will be measured using the 7-item version of the Generalized Anxiety Disorders scale (GAD-7), which assesses the frequency of nervousness, worry, difficulty relaxing, restlessness, irritability, and fear. The minimum value on this scale is 0 and the maximum value is 21. Higher scores represent worse outcomes.
measure: Change in depressive symptoms
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Depressive symptoms will be measured using the 8-item version of the Patient Health Questionnaire (PHQ-8), which assesses the frequency of anhedonia, depressed mood, sleep difficulties, lack of energy, appetite disturbance, low self-esteem, trouble concentrating, and psychomotor retardation.The minimum value on this scale is 0 and the maximum value is 24. Higher scores represent worse outcomes.
measure: Change in hopelessness
time frame: Baseline, 5-week follow-up (immediately post-intervention), and 10-week follow-up
description: Hopelessness will be measured using the Hopelessness Assessment in Illness Questionnaire. The scale includes 8 items assessing the degree to which patients have felt hopelessness, discouragement, and dread. The minimum value on this scale is 0 and the maximum value is 16. Higher scores represent worse outcomes.
arm group label: Meaning-Centered Pain Coping Skills Training
arm group type: Experimental
description: Four, 45-60 minute, videoconference-delivered sessions focus on training participants in cognitive and behavioral skills (e.g., guided imagery) for managing pain.
arm group label: Standard Care
arm group type: No Intervention
description: Information and referrals for free services available through the Duke Cancer Patient Support Program.
intervention type: Behavioral
intervention name: Meaning-Centered Pain Coping Skills Training
description: The goal of this intervention is to help participants manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.
arm group label: Meaning-Centered Pain Coping Skills Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph G Winger, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No