<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/NCT01674881</url>
  </required_header>
  <id_info>
    <org_study_id>EPoS-1</org_study_id>
    <nct_id>NCT01674881</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors</brief_title>
  <official_title>A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for&#xD;
      breast cancer experience negative sequelae in the form of pain following treatment. Chronic&#xD;
      pain is known to be associated with impaired social and emotional functioning, and thus&#xD;
      presents a particular concern.&#xD;
&#xD;
      Mindfulness-based intervention is among the complementary, psychological treatments, which&#xD;
      cancer patients commonly seek out in relation to the course of their illness. Despite the&#xD;
      popularity of mindfulness-based intervention among cancer patients, no studies have so far&#xD;
      investigated the effect of mindfulness-based intervention on chronic pain in breast cancer&#xD;
      patients. While no studies so far have focused on pain, there is evidence to suggest that&#xD;
      mindfulness-based intervention is associated with improved psychosocial adaption to cancer.&#xD;
      Furthermore, non-cancer research suggests that mindfulness-based intervention is associated&#xD;
      with reduced pain experiences.&#xD;
&#xD;
      The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy&#xD;
      (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment&#xD;
      for breast cancer and who experience chronic pain, will be randomized to an intervention&#xD;
      group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the&#xD;
      same time points, i.e. before the intervention (baseline), and three times after the&#xD;
      intervention/control condition, with the last follow-up 6 months after the intervention. In&#xD;
      addition, a number of potential moderators and mediators of the outcome will be explored. For&#xD;
      example, recent studies indicate that adult attachment style may constitute an important&#xD;
      moderator and/or mediator in the development of pain, and preliminary research has suggested&#xD;
      that attachment style may moderate the effect of mindfulness-based intervention.&#xD;
&#xD;
      The results will provide valuable new knowledge about the potential of MBCT as a treatment&#xD;
      strategy for chronic pain in breast cancer patients, will contribute to the clarification of&#xD;
      underlying mechanisms in the experience of and coping with pain, which could help the&#xD;
      development of more effective, individualized interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>Revised McGill Pain Questionnaire Short Form&#xD;
VAS: pain interference&#xD;
Additional items: Pain descriptors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>The Five Facet Mindfulness Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self compassion</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>the Self Compassion Scale Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>the Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>the Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Well-being</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>the WHO-5</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Attachment orientation</measure>
    <time_frame>Baseline</time_frame>
    <description>the Experiences in Close Relationships Short Version</description>
  </other_outcome>
  <other_outcome>
    <measure>Alexithymia</measure>
    <time_frame>From baseline until 6 months</time_frame>
    <description>the Toronto Alexithymia Scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive MBCT for 8 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group is a waitlist control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mindfulness-Based Cognitive Therapy</intervention_name>
    <description>MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).&#xD;
Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD.</description>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist</intervention_name>
    <description>Waitlist: participants are offered the intervention (MBCT) after the completion of the main study</description>
    <arm_group_label>Waitlist control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A timeframe of &gt;3 months from surgery, radiation- and chemotherapy and a minimum score&#xD;
             of &gt;3 on a pain scale from 0-10 corresponding to moderate pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric&#xD;
             illnesses, insufficient ability to speak and understand Danish, and chronic pain&#xD;
             otherwise associated with the musculoskeletal system&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maja Johannsen, PhD-fellow, MSc psychology</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Zachariae, Professor, MDSci., MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University and Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>April 13, 2015</last_update_submitted>
  <last_update_submitted_qc>April 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>breast cancer</keyword>
  <keyword>chronic pain</keyword>
  <keyword>mediators</keyword>
  <keyword>distress</keyword>
  <keyword>Breast cancer survivors</keyword>
  <keyword>Effectiveness of MBCT on chronic pain</keyword>
  <keyword>Potential mediators and moderators</keyword>
  <keyword>Effectiveness of MBCT on psychological symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Chronic Pain</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/NCT01674881
org study id: EPoS-1
nct id: NCT01674881
lead sponsor: 
has dmc: No
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for
      breast cancer experience negative sequelae in the form of pain following treatment. Chronic
      pain is known to be associated with impaired social and emotional functioning, and thus
      presents a particular concern.

      Mindfulness-based intervention is among the complementary, psychological treatments, which
      cancer patients commonly seek out in relation to the course of their illness. Despite the
      popularity of mindfulness-based intervention among cancer patients, no studies have so far
      investigated the effect of mindfulness-based intervention on chronic pain in breast cancer
      patients. While no studies so far have focused on pain, there is evidence to suggest that
      mindfulness-based intervention is associated with improved psychosocial adaption to cancer.
      Furthermore, non-cancer research suggests that mindfulness-based intervention is associated
      with reduced pain experiences.

      The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy
      (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment
      for breast cancer and who experience chronic pain, will be randomized to an intervention
      group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the
      same time points, i.e. before the intervention (baseline), and three times after the
      intervention/control condition, with the last follow-up 6 months after the intervention. In
      addition, a number of potential moderators and mediators of the outcome will be explored. For
      example, recent studies indicate that adult attachment style may constitute an important
      moderator and/or mediator in the development of pain, and preliminary research has suggested
      that attachment style may moderate the effect of mindfulness-based intervention.

      The results will provide valuable new knowledge about the potential of MBCT as a treatment
      strategy for chronic pain in breast cancer patients, will contribute to the clarification of
      underlying mechanisms in the experience of and coping with pain, which could help the
      development of more effective, individualized interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain
time frame: From baseline until 6 months
description: Revised McGill Pain Questionnaire Short Form
VAS: pain interference
Additional items: Pain descriptors
measure: Mindfulness
time frame: From baseline until 6 months
description: The Five Facet Mindfulness Questionnaire
measure: Self compassion
time frame: From baseline until 6 months
description: the Self Compassion Scale Short Form
measure: Pain Catastrophizing
time frame: From baseline until 6 months
description: the Pain Catastrophizing Scale
measure: Depression and anxiety
time frame: From baseline until 6 months
description: the Hospital Anxiety and Depression Scale
measure: Well-being
time frame: From baseline until 6 months
description: the WHO-5
measure: Attachment orientation
time frame: Baseline
description: the Experiences in Close Relationships Short Version
measure: Alexithymia
time frame: From baseline until 6 months
description: the Toronto Alexithymia Scale
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
arm group type: Experimental
description: This group will receive MBCT for 8 consecutive weeks.
arm group label: Waitlist control group
arm group type: Other
description: This group is a waitlist control group.
intervention type: Other
intervention name: Mindfulness-Based Cognitive Therapy
description: MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).
Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD.
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
intervention type: Other
intervention name: Waitlist
description: Waitlist: participants are offered the intervention (MBCT) after the completion of the main study
arm group label: Waitlist control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maja Johannsen, PhD-fellow, MSc psychology
role: Principal Investigator
affiliation: Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital
last name: Robert Zachariae, Professor, MDSci., MSc
role: Principal Investigator
affiliation: Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Chronic Pain