<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/NCT03834532</url>
  </required_header>
  <id_info>
    <org_study_id>2018-05-0009</org_study_id>
    <nct_id>NCT03834532</nct_id>
  </id_info>
  <brief_title>Living Well After Breast Surgery</brief_title>
  <official_title>Living Well After Breast Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</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>
      Decision making about whether to have breast reconstruction after mastectomy can be&#xD;
      difficult, and previous studies have found that many women are not well informed about their&#xD;
      options. Patient decision aids can improve decision quality for a variety of health&#xD;
      conditions. This pilot randomized study seeks to determine how a patient decision aid about&#xD;
      breast reconstruction affects the quality of decisions about reconstruction including patient&#xD;
      knowledge, concordance between preferences and treatment, and decisional regret.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast&#xD;
      reconstruction decision aid or an educational website on healthy living with breast cancer.&#xD;
&#xD;
      Participants will complete up to three surveys; a baseline survey before viewing the decision&#xD;
      aid or website, a second survey immediately after viewing the decision aid or website, and a&#xD;
      third survey six months after surgery. Tablets will be made available to participants at the&#xD;
      study site through which they can complete the surveys and view the decision aid or website.&#xD;
      Participants will have the options of viewing the decision aid or website outside of the&#xD;
      study site, and completing the three surveys electronically or on paper.&#xD;
&#xD;
      The baseline survey and second survey will each take approximately 45 minutes for&#xD;
      participants to complete. The third survey will take approximately 30 minutes for&#xD;
      participants to complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</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 enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients enrolled per month</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients retained at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects knowledge about reconstruction.</measure>
    <time_frame>6 months</time_frame>
    <description>Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.</measure>
    <time_frame>6 months</time_frame>
    <description>Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Rating Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.</measure>
    <time_frame>6 months</time_frame>
    <description>Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Ranking Task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.</measure>
    <time_frame>6 months</time_frame>
    <description>Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Decisional Conflict Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.</measure>
    <time_frame>6 months</time_frame>
    <description>Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by treatment outcome recorded in patient electronic health record (EHR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects decision making outcomes.</measure>
    <time_frame>6 months</time_frame>
    <description>Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>How a patient decision aid about breast reconstruction affects decision making outcomes.</measure>
    <time_frame>6 months</time_frame>
    <description>Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Stage I Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage III Breast Cancer</condition>
  <condition>Ductal Carcinoma in Situ</condition>
  <condition>Ductal Breast Carcinoma</condition>
  <condition>Lobular Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breast reconstruction decision aid</intervention_name>
    <description>The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Web-based tool</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational website</intervention_name>
    <description>The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Website</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Adult (18 years or older)&#xD;
&#xD;
          -  New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or&#xD;
             Ductal Carcinoma in Situ (DCIS)&#xD;
&#xD;
          -  Not yet had mastectomy&#xD;
&#xD;
          -  Considering or planning to have mastectomy&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Competent to make health care decisions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma&#xD;
&#xD;
          -  Already had mastectomy for this diagnosis&#xD;
&#xD;
          -  Planning to have breast conservation therapy&#xD;
&#xD;
          -  Not being treated by a Texas Oncology surgeon or oncologist&#xD;
&#xD;
          -  Not able to read and speak English&#xD;
&#xD;
          -  Not competent to make health care decisions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Michael P Pignone</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </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</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
    <mesh_term>Carcinoma, Lobular</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/NCT03834532
org study id: 2018-05-0009
nct id: NCT03834532
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Decision making about whether to have breast reconstruction after mastectomy can be
      difficult, and previous studies have found that many women are not well informed about their
      options. Patient decision aids can improve decision quality for a variety of health
      conditions. This pilot randomized study seeks to determine how a patient decision aid about
      breast reconstruction affects the quality of decisions about reconstruction including patient
      knowledge, concordance between preferences and treatment, and decisional regret.
Enrolled participants will be randomized to 1 of 2 arms; participants may receive a breast
      reconstruction decision aid or an educational website on healthy living with breast cancer.

      Participants will complete up to three surveys; a baseline survey before viewing the decision
      aid or website, a second survey immediately after viewing the decision aid or website, and a
      third survey six months after surgery. Tablets will be made available to participants at the
      study site through which they can complete the surveys and view the decision aid or website.
      Participants will have the options of viewing the decision aid or website outside of the
      study site, and completing the three surveys electronically or on paper.

      The baseline survey and second survey will each take approximately 45 minutes for
      participants to complete. The third survey will take approximately 30 minutes for
      participants to complete.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants enrolled in the study will complete a baseline survey. Participants will then be randomized to receive a breast reconstruction decision aid or an educational website on healthy living with breast cancer. Participants will complete a second survey after viewing the assigned material. Participants may be invited to complete a third survey six months after surgery.
measure: Number of patients enrolled per month
time frame: 12 months
description: To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the number of patients enrolled per month.
measure: Proportion of patients retained at 6 months
time frame: 6 months
description: To determine the feasibility of recruiting eligible patients and delivering the breast reconstruction decision support intervention. Measured by the proportion of patients retained through the 6 month outcome assessment.
measure: How a patient decision aid about breast reconstruction affects knowledge about reconstruction.
time frame: 6 months
description: Change in knowledge (e.g. advantages and disadvantages) about breast reconstruction from baseline to post intervention measured by Decision Quality Instrument - Reconstruction Module.
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
time frame: 6 months
description: Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Rating Scale.
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
time frame: 6 months
description: Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Ranking Task.
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
time frame: 6 months
description: Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by Decisional Conflict Scale.
measure: How a patient decision aid about breast reconstruction affects concordance of patient values and decisions about reconstruction.
time frame: 6 months
description: Concordance between preferences (e.g. concerns about appearance, complications, recovery) regarding breast reconstruction and treatment outcome (mastectomy with immediate breast reconstruction, mastectomy without immediate breast reconstruction) at 6-month follow-up measured by treatment outcome recorded in patient electronic health record (EHR).
measure: How a patient decision aid about breast reconstruction affects decision making outcomes.
time frame: 6 months
description: Regret with decision related to breast reconstruction at 6-month follow-up measured by Decisional Regret Scale.
measure: How a patient decision aid about breast reconstruction affects decision making outcomes.
time frame: 6 months
description: Satisfaction with decision related to breast reconstruction at 6-month follow-up measured by Satisfaction with Decisions Scale.
arm group label: Intervention
arm group type: Experimental
description: Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site.
arm group label: Control
arm group type: Active Comparator
description: Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site.
intervention type: Other
intervention name: Breast reconstruction decision aid
description: The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure.
arm group label: Intervention
other name: Web-based tool
intervention type: Other
intervention name: Educational website
description: The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
arm group label: Control
other name: Website
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Michael P Pignone
investigator title: Professor of Medicine
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Intraductal, Noninfiltrating
mesh term: Carcinoma, Ductal, Breast
mesh term: Carcinoma, Lobular