<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/NCT01723943</url>
  </required_header>
  <id_info>
    <org_study_id>8061</org_study_id>
    <secondary_id>NCI-2013-01838</secondary_id>
    <secondary_id>34500</secondary_id>
    <secondary_id>8061</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <secondary_id>R01CA114561</secondary_id>
    <nct_id>NCT01723943</nct_id>
    <nct_alias>NCT02032992</nct_alias>
  </id_info>
  <brief_title>Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients</brief_title>
  <official_title>Psychoeducation for Spouses/Partners of Women With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies educational counseling in improving communication and&#xD;
      quality of life in spouses and breast cancer patients. An outpatient education and behavior&#xD;
      skills training program may help spouses and patients with breast cancer communicate better&#xD;
      and improve quality of life. It is not yet known whether educational counseling is more&#xD;
      effective than an educational booklet in improving communication and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To test whether the intervention has a beneficial effect on spouses' outcome variables.&#xD;
&#xD;
      II. To test whether the intervention has a beneficial effect on ill partners (patients')&#xD;
      outcome variables.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Participants receive the &quot;What's Happening to the Woman I Love?&quot; booklet, which&#xD;
      focuses on ways to understand and deal with marital communication and relationship issues&#xD;
      arising from breast cancer diagnosis.&#xD;
&#xD;
      ARM II: Participants undergo the Helping Her Heal educational counseling program comprising 5&#xD;
      1-hour sessions 2 weeks apart.&#xD;
&#xD;
      SESSION I: Participants learn stress management skills and discover ways stress affects&#xD;
      themselves and their partner.&#xD;
&#xD;
      SESSION II: Participants practice attentive listening and reduce the tendency to try to&#xD;
      distract patients from talking about sad or difficult aspects of the cancer experience.&#xD;
&#xD;
      SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add&#xD;
      to their understanding of what she is thinking and feeling, and to add to their ways of&#xD;
      supporting her during especially difficult times with the cancer.&#xD;
&#xD;
      SESSION IV: Participants learn strategies for physically reconnecting with spouses.&#xD;
&#xD;
      SESSION V: Participants review skills from prior sessions, identify strategies he or she will&#xD;
      continue to use to manage their personal stress, and identify ways to maintain connection and&#xD;
      support.&#xD;
&#xD;
      After completion of study, patients are followed up at 3 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Supportive Care</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in State-Trait Anxiety Inventory (STAI) spouse scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>The primary analysis will be multivariate analysis of covariance (MANCOVA) with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include analysis of covariance (ANCOVA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in STAI patient scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CES-D patient scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in spouse/partner Skills Checklist scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in spouse/partner CASE scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient MIS scores</measure>
    <time_frame>Baseline to 8 weeks</time_frame>
    <description>Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Anxiety Disorder</condition>
  <condition>Depression</condition>
  <condition>Ductal Breast Carcinoma in Situ</condition>
  <condition>Lobular Breast Carcinoma in Situ</condition>
  <condition>Psychosocial Effects of Cancer and Its Treatment</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II 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 I (educational booklet)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive the &quot;What's Happening to the Woman I Love?&quot; booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (Helping Her Heal program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.&#xD;
SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.&#xD;
SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.&#xD;
SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.&#xD;
SESSION IV: Participants learn strategies for physically reconnecting with spouses.&#xD;
SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational intervention</intervention_name>
    <description>Receive the &quot;What's Happening to the Woman I Love?&quot; booklet</description>
    <arm_group_label>Arm I (educational booklet)</arm_group_label>
    <other_name>intervention, educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>counseling intervention</intervention_name>
    <description>Undergo Helping Her Heal educational counseling program</description>
    <arm_group_label>Arm II (Helping Her Heal program)</arm_group_label>
    <other_name>counseling and communications studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational intervention</intervention_name>
    <description>Undergo Helping Her Heal educational counseling program</description>
    <arm_group_label>Arm II (Helping Her Heal program)</arm_group_label>
    <other_name>intervention, educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>psychosocial support for caregiver</intervention_name>
    <description>Undergo Helping Her Heal educational counseling program</description>
    <arm_group_label>Arm II (Helping Her Heal program)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spouses (in both heterosexual couples and same-sex couples) of women diagnosed within&#xD;
             the past 6 months with stage 0, I, II or III breast cancer (in situ/local/regional&#xD;
             disease) will be eligible to participate, as will the diagnosed wife/partner&#xD;
&#xD;
          -  Spouses and patients must be married or cohabiting for at least 6 months&#xD;
&#xD;
          -  Spouses and patients must have English as one of their languages of choice (they can&#xD;
             be multilingual)&#xD;
&#xD;
          -  Spouses and patients must live within 25 miles of the University of Washington (UW)&#xD;
             study center&#xD;
&#xD;
          -  Spouses/partners must be willing to give a sample of blood and/or sputum at time of&#xD;
             first and second data collections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman diagnosed with stage IV or recurrent breast cancer or who is &gt; 6 months&#xD;
             post-diagnosis&#xD;
&#xD;
          -  Woman and/or spouse not able to read and write in English&#xD;
&#xD;
          -  Spouses could not participate if the ill partner refused participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances Lewis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</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>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT01723943
org study id: 8061
secondary id: NCI-2013-01838
secondary id: 34500
secondary id: 8061
secondary id: P30CA015704
secondary id: R01CA114561
nct id: NCT01723943
nct alias: NCT02032992
lead sponsor: 
collaborator: 
has dmc: No
This randomized clinical trial studies educational counseling in improving communication and
      quality of life in spouses and breast cancer patients. An outpatient education and behavior
      skills training program may help spouses and patients with breast cancer communicate better
      and improve quality of life. It is not yet known whether educational counseling is more
      effective than an educational booklet in improving communication and quality of life.
PRIMARY OBJECTIVES:

      I. To test whether the intervention has a beneficial effect on spouses' outcome variables.

      II. To test whether the intervention has a beneficial effect on ill partners (patients')
      outcome variables.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Participants receive the "What's Happening to the Woman I Love?" booklet, which
      focuses on ways to understand and deal with marital communication and relationship issues
      arising from breast cancer diagnosis.

      ARM II: Participants undergo the Helping Her Heal educational counseling program comprising 5
      1-hour sessions 2 weeks apart.

      SESSION I: Participants learn stress management skills and discover ways stress affects
      themselves and their partner.

      SESSION II: Participants practice attentive listening and reduce the tendency to try to
      distract patients from talking about sad or difficult aspects of the cancer experience.

      SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add
      to their understanding of what she is thinking and feeling, and to add to their ways of
      supporting her during especially difficult times with the cancer.

      SESSION IV: Participants learn strategies for physically reconnecting with spouses.

      SESSION V: Participants review skills from prior sessions, identify strategies he or she will
      continue to use to manage their personal stress, and identify ways to maintain connection and
      support.

      After completion of study, patients are followed up at 3 and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double
measure: Change in State-Trait Anxiety Inventory (STAI) spouse scores
time frame: Baseline to 8 weeks
description: The primary analysis will be multivariate analysis of covariance (MANCOVA) with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include analysis of covariance (ANCOVA).
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) spouse scores
time frame: Baseline to 8 weeks
description: The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
measure: Change in STAI patient scores
time frame: Baseline to 8 weeks
description: The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
measure: Change in CES-D patient scores
time frame: Baseline to 8 weeks
description: The primary analysis will be MANCOVA with 3 outcome variables, controlling for baseline values and additional covariates identified during the preparatory analyses. Further analyses done on each outcome variable separately to determine if the outcome had a stronger effect on some. Secondary analyses will include ANCOVA.
measure: Change in spouse/partner Skills Checklist scores
time frame: Baseline to 8 weeks
description: Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
measure: Change in spouse/partner CASE scores
time frame: Baseline to 8 weeks
description: Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
measure: Change in spouse/partner Mutuality and Interpersonal Sensitivity Scale (MIS) scores
time frame: Baseline to 8 weeks
description: Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
measure: Change in patient MIS scores
time frame: Baseline to 8 weeks
description: Secondary analyses will use ANCOVA, controlling for baseline variables, to test for intervention versus control differences. A significant improvement in an intermediate outcome variable would be consistent with that variable being a mediator of the treatment effect on the primary outcomes.
arm group label: Arm I (educational booklet)
arm group type: Active Comparator
description: Participants receive the "What's Happening to the Woman I Love?" booklet, which focuses on ways to understand and deal with marital communication and relationship issues arising from breast cancer diagnosis.
arm group label: Arm II (Helping Her Heal program)
arm group type: Experimental
description: Participants undergo the Helping Her Heal educational counseling program comprising 5 1-hour sessions 2 weeks apart.
SESSION I: Participants learn stress management skills and discover ways stress affects themselves and their partner.
SESSION II: Participants practice attentive listening and reduce the tendency to try to distract patients from talking about sad or difficult aspects of the cancer experience.
SESSION III: Patients learn to help their spouse talk when she is quiet or withdrawn, to add to their understanding of what she is thinking and feeling, and to add to their ways of supporting her during especially difficult times with the cancer.
SESSION IV: Participants learn strategies for physically reconnecting with spouses.
SESSION V: Participants review skills from prior sessions, identify strategies he or she will continue to use to manage their personal stress, and identify ways to maintain connection and support.
intervention type: Other
intervention name: educational intervention
description: Receive the "What's Happening to the Woman I Love?" booklet
arm group label: Arm I (educational booklet)
other name: intervention, educational
intervention type: Other
intervention name: counseling intervention
description: Undergo Helping Her Heal educational counseling program
arm group label: Arm II (Helping Her Heal program)
other name: counseling and communications studies
intervention type: Other
intervention name: educational intervention
description: Undergo Helping Her Heal educational counseling program
arm group label: Arm II (Helping Her Heal program)
other name: intervention, educational
intervention type: Other
intervention name: psychosocial support for caregiver
description: Undergo Helping Her Heal educational counseling program
arm group label: Arm II (Helping Her Heal program)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frances Lewis
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal, Breast
mesh term: Breast Carcinoma In Situ
mesh term: Carcinoma, Intraductal, Noninfiltrating
mesh term: Carcinoma, Lobular
mesh term: Anxiety Disorders