<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/NCT03025139</url>
  </required_header>
  <id_info>
    <org_study_id>16-000817</org_study_id>
    <secondary_id>NCI-2016-01396</secondary_id>
    <secondary_id>R01CA200977</secondary_id>
    <nct_id>NCT03025139</nct_id>
  </id_info>
  <brief_title>Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)</brief_title>
  <acronym>PTW</acronym>
  <official_title>Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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 randomized phase III trial studies how well mindfulness meditation or survivorship&#xD;
      education work in improving behavioral symptoms in younger stage 0-III breast cancer&#xD;
      survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help&#xD;
      patients change the way they react to environmental triggers that may cause a negative&#xD;
      reaction. Survivorship education after treatment may reduce stress and improve the well-being&#xD;
      and quality of life of patients with breast cancer. Mindfulness meditation or survivorship&#xD;
      education may help improve the health behaviors of younger breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the efficacy of two different types of group interventions (mindfulness and&#xD;
      survivorship education), specifically tailored to the needs of younger female breast cancer&#xD;
      survivors, in reducing depressive symptoms, compared to a usual care control group.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the efficacy of the two interventions relative to a usual care control group on&#xD;
      fatigue, sleep disturbance, and vasomotor symptoms.&#xD;
&#xD;
      II. To examine the efficacy of the two interventions relative to a usual care control group&#xD;
      on circulating and genomic markers of inflammation.&#xD;
&#xD;
      III. To explore potential moderators and mediators of intervention efficacy in the two&#xD;
      intervention groups.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 3 arms.&#xD;
&#xD;
      ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation&#xD;
      class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions&#xD;
      that include guided meditation, questions, and discussion of how to maintain a mindfulness&#xD;
      practice over 1 hour once monthly for 3 months.&#xD;
&#xD;
      ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education&#xD;
      class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic&#xD;
      newsletters with tailored information about topics of interest to younger survivors,&#xD;
      including cancer-related events in the community and tips about following through on&#xD;
      recommendations for healthy living.&#xD;
&#xD;
      ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months.&#xD;
      Patients are then offered a choice of participating in Arm A or Arm B.&#xD;
&#xD;
      After completion of study, patients are followed up at 3 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score</measure>
    <time_frame>2 weeks post-intervention to 6 months</time_frame>
    <description>The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue assessed by Fatigue Symptom Inventory</measure>
    <time_frame>2 weeks post-intervention to 6 months</time_frame>
    <description>Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.</measure>
    <time_frame>2 weeks post-intervention to 6 months</time_frame>
    <description>Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)</measure>
    <time_frame>2 weeks post-intervention to 6 months</time_frame>
    <description>Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep disturbance assessed by Insomnia Severity Index</measure>
    <time_frame>2 weeks post-intervention to 6 months</time_frame>
    <description>Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mediators of intervention efficacy assessed by questionnaire</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderators of intervention efficacy assessed by questionnaire</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>Early-Stage Breast Carcinoma</condition>
  <condition>Stage 0 Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage IIA Breast Cancer</condition>
  <condition>Stage IIB Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A (MAPs)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (SE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Attend survivorship education</description>
    <arm_group_label>Arm B (SE)</arm_group_label>
    <arm_group_label>Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm A (MAPs)</arm_group_label>
    <arm_group_label>Arm B (SE)</arm_group_label>
    <arm_group_label>Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Meditation Therapy</intervention_name>
    <description>Attend mindfulness meditation</description>
    <arm_group_label>Arm A (MAPs)</arm_group_label>
    <arm_group_label>Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)</arm_group_label>
    <other_name>Meditation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (MAPs)</arm_group_label>
    <arm_group_label>Arm B (SE)</arm_group_label>
    <arm_group_label>Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III)&#xD;
             prior to age 50, and are within 5 years of diagnosis&#xD;
&#xD;
          -  Have completed all surgery, radiation, and/or chemotherapy treatments at least 6&#xD;
             months previously; may still be receiving trastuzumab or endocrine adjuvant therapy&#xD;
&#xD;
          -  Ability to complete evaluation surveys in English&#xD;
&#xD;
          -  Have evidence of at least mild clinical depression on a standardized screening&#xD;
             questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis&#xD;
             following the breast cancer (excluding non-melanoma skin cancer)&#xD;
&#xD;
          -  Unable to commit to intervention schedule (6 weekly group meetings)&#xD;
&#xD;
          -  Actively practicing mindfulness meditation&#xD;
&#xD;
          -  Has another serious or chronic medical or psychiatric condition that contributes to&#xD;
             substantial physical or emotional disability that would detract from participating in&#xD;
             either of the intervention programs or from the measurement of intervention outcomes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Ganz</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</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>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>younger women</keyword>
  <keyword>education</keyword>
  <keyword>mindfulness meditation</keyword>
  <keyword>depression</keyword>
  <keyword>cancer survivor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
    <mesh_term>Behavioral Symptoms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03025139/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 18, 2023</submitted>
    <returned>June 13, 2023</returned>
  </pending_results>
  <!-- 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/NCT03025139
org study id: 16-000817
secondary id: NCI-2016-01396
secondary id: R01CA200977
nct id: NCT03025139
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized phase III trial studies how well mindfulness meditation or survivorship
      education work in improving behavioral symptoms in younger stage 0-III breast cancer
      survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help
      patients change the way they react to environmental triggers that may cause a negative
      reaction. Survivorship education after treatment may reduce stress and improve the well-being
      and quality of life of patients with breast cancer. Mindfulness meditation or survivorship
      education may help improve the health behaviors of younger breast cancer survivors.
PRIMARY OBJECTIVES:

      I. To evaluate the efficacy of two different types of group interventions (mindfulness and
      survivorship education), specifically tailored to the needs of younger female breast cancer
      survivors, in reducing depressive symptoms, compared to a usual care control group.

      SECONDARY OBJECTIVES:

      I. To compare the efficacy of the two interventions relative to a usual care control group on
      fatigue, sleep disturbance, and vasomotor symptoms.

      II. To examine the efficacy of the two interventions relative to a usual care control group
      on circulating and genomic markers of inflammation.

      III. To explore potential moderators and mediators of intervention efficacy in the two
      intervention groups.

      OUTLINE: Patients are randomized to 1 of 3 arms.

      ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation
      class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions
      that include guided meditation, questions, and discussion of how to maintain a mindfulness
      practice over 1 hour once monthly for 3 months.

      ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education
      class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic
      newsletters with tailored information about topics of interest to younger survivors,
      including cancer-related events in the community and tips about following through on
      recommendations for healthy living.

      ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months.
      Patients are then offered a choice of participating in Arm A or Arm B.

      After completion of study, patients are followed up at 3 and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
time frame: 2 weeks post-intervention to 6 months
description: The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.
measure: Change in fatigue assessed by Fatigue Symptom Inventory
time frame: 2 weeks post-intervention to 6 months
description: Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
measure: Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
time frame: 2 weeks post-intervention to 6 months
description: Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
measure: Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
time frame: 2 weeks post-intervention to 6 months
description: Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
measure: Change in sleep disturbance assessed by Insomnia Severity Index
time frame: 2 weeks post-intervention to 6 months
description: Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
measure: Mediators of intervention efficacy assessed by questionnaire
time frame: Up to 6 months
description: Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
measure: Moderators of intervention efficacy assessed by questionnaire
time frame: Up to 6 months
description: Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.
arm group label: Arm A (MAPs)
arm group type: Active Comparator
description: Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.
arm group label: Arm B (SE)
arm group type: Active Comparator
description: Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.
arm group label: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
arm group type: Active Comparator
description: Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.
intervention type: Other
intervention name: Educational Intervention
description: Attend survivorship education
arm group label: Arm B (SE)
arm group label: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm A (MAPs)
arm group label: Arm B (SE)
arm group label: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
intervention type: Procedure
intervention name: Meditation Therapy
description: Attend mindfulness meditation
arm group label: Arm A (MAPs)
arm group label: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
other name: Meditation
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (MAPs)
arm group label: Arm B (SE)
arm group label: Arm C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP)
criteria: 
gender: Female
minimum age: N/A
maximum age: 49 Years
healthy volunteers: No
last name: Patricia Ganz
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Carcinoma In Situ
mesh term: Behavioral Symptoms
provided document: 
submitted: May 18, 2023
returned: June 13, 2023