<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/NCT04491591</url>
  </required_header>
  <id_info>
    <org_study_id>202005217</org_study_id>
    <secondary_id>R18HS026699</secondary_id>
    <nct_id>NCT04491591</nct_id>
  </id_info>
  <brief_title>Implementing BREASTChoice Into Practice</brief_title>
  <official_title>Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      Breast reconstruction after mastectomy is a highly personal decision. Although it can restore&#xD;
      quality of life for many, there are numerous risks associated with the procedure. The risk of&#xD;
      complications exceeds that of most elective procedures. In past work, a clinical decision&#xD;
      support tool, BREASTChoice, with personalized risk information and patient preferences, was&#xD;
      created to be used to address these issues. It was modified with extensive stakeholder input&#xD;
      and built to be incorporated into electronic health records and patient portals. This&#xD;
      randomized control trial will evaluate whether the implementation of BREASTChoice into&#xD;
      routine care delivery is more effective than a control website, at improving the quality of&#xD;
      reconstruction decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched&#xD;
      to test the workflow and procedures. The investigators plan to recruit up to 20 patients,&#xD;
      continuing until procedures are smooth and ready for the randomized trial. The investigators&#xD;
      will follow these same procedures as the trial, other than randomization, to test the&#xD;
      workflow and tool use programming.&#xD;
&#xD;
      For the RCT, patients considering mastectomy at academic and community practices (n=340) will&#xD;
      be randomized over 18 months to use BREASTChoice or a control website.&#xD;
&#xD;
      After the patient participant consents to be in the study, they will be randomized (using&#xD;
      computer random assignment) participants to view the clinical decision support tool,&#xD;
      BREASTChoice or the attention control website, using block randomization (block size of 2 and&#xD;
      4). Depending on the clinic work-flow, the patients may be sent the link to the tool or&#xD;
      control website: 1) by email or MyChart message, prior to their visit with the plastic or&#xD;
      reconstruction surgeon, for them to complete from home or in the waiting room (ideal and&#xD;
      preferred approach); 2) by email or MyChart, in person or virtually at the time of their&#xD;
      plastic or reconstruction visit, for patients that have same-day breast surgeon and plastic&#xD;
      reconstruction surgeon visits, with time to wait in between appointments; or 3) by email or&#xD;
      MyChart, after the plastic surgery appointment, if they have not yet made a decision about&#xD;
      reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or&#xD;
      they want or need more time to decide on their surgery choices). Participants will be sent&#xD;
      the link via MyChart unless they do not have a MyChart account. In that case, they will be&#xD;
      sent the link via email. Study staff will be available to answer questions about MyChart via&#xD;
      phone or email.&#xD;
&#xD;
      BREASTChoice is interactive with multiple modules. It starts with facts about breast&#xD;
      reconstruction. Modules describe pros and cons of reconstruction, reconstruction timing, and&#xD;
      reconstruction types. When discussing reconstruction timing, a risk prediction model pulls&#xD;
      health data from the EHR (asking patients information in the model that is missing) to&#xD;
      personalize risk of complications from immediate breast reconstruction. It also shows average&#xD;
      risks for mastectomy alone and mastectomy plus immediate breast reconstruction so women can&#xD;
      compare their personalized risk to average risks. Each module contains real patient quotes, a&#xD;
      section called &quot;Let's review&quot; which checks patients' understanding, and &quot;What matters to&#xD;
      you&quot;, which elicits patients' preferences. Diverse patient photos and outcomes are provided.&#xD;
      It is written at a 7th grade reading level. Data on patients' risks and a summary of her&#xD;
      preferences are sent to their plastic/reconstructive surgeon to view in the electronic health&#xD;
      record. The tool takes the patient about 20minutes to complete.&#xD;
&#xD;
      Control Website: The investigators chose an attention control, rather than usual care, to&#xD;
      reduce differences between arms in participant expectation of benefit. Those in the control&#xD;
      arm will get a link to an NCI website about breast reconstruction. That website includes 10&#xD;
      sections with information about types of breast reconstruction, timing, recovery, risks,&#xD;
      cancer surveillance and additional resources. The website provides information, but does not&#xD;
      include values clarification or tailored risk information. It is not interactive and does not&#xD;
      include photos..&#xD;
&#xD;
      (https://www.cancer.gov/types/breast/reconstruction-fact-sheet)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 4, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">September 2, 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge as measured by Decision Quality Instrument</measure>
    <time_frame>After initial visit but before surgery, estimated to be before day 7</time_frame>
    <description>-The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items.&#xD;
*For participant arms only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preference concordance as measured by the Decision Quality Instrument</measure>
    <time_frame>Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR</time_frame>
    <description>-The investigators will first estimate the patient's preferred treatment (mastectomy alone versus mastectomy with reconstruction), by inputting her values (entered into BREASTChoice or control survey) into a previously developed statistical model to compute her preferred treatment. The investigators will compare her preferred treatments to actual treatment received, with concordance determined by agreement between preferred and actual treatment received. The investigators will consider &quot;actual treatment received&quot; to be delayed reconstruction, if the patient states an intention to have delayed reconstruction, as she might not have started this process during the study.&#xD;
*For participant arms only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decisional conflict as measured by the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale for decisional conflict</measure>
    <time_frame>After initial visit but before surgery, estimated to be before day 7</time_frame>
    <description>-The validated, widely-used SURE measure of decisional conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict.&#xD;
*For participant arms only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare number of high-risk participants from each arm who chose breast reconstruction</measure>
    <time_frame>After patient participation (approximately 18 months)</time_frame>
    <description>-Participants will be considered high-risk if their risk exceeds two times the population average</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider intention to engage in shared decision making as measured by the change in the mean CPD (Continuing Professional Development)-Reaction scale</measure>
    <time_frame>Assessed pre- and post-study (approximately 24 months)</time_frame>
    <description>-CPD Reaction scale is a 12-item measure, each item with a scale of 1-7. Measure change in mean response. Higher change in mean indicates behavior change. Constructs assessed include Intention, Social Influence, Beliefs about capabilities, Moral norm, and beliefs about consequence.&#xD;
**For clinician arm only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge as measured by knowledge questions developed in previous studies</measure>
    <time_frame>After initial visit but before surgery, estimated before day 7</time_frame>
    <description>-This is an 11-item measure. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items, using the approach described for the DQI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consult time as measured by time spent with clinician during the visit</measure>
    <time_frame>Initial visit (day 1)</time_frame>
    <description>-Consult time using the BREASTChoice will be compared to consult using the attention control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability as measured by the system usability scale (SUS)</measure>
    <time_frame>After initial visit but before surgery, estimated to be before day 7</time_frame>
    <description>-The SUS is a 10-item measure of how easy a website is to use. A usability score is calculated by adding the item and multiplied the sum by 2.5. Scores can range from 0-100 with higher scores indicating greater usability.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">412</enrollment>
  <condition>Breast Reconstruction</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>BREASTChoice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After consent, the participant will be randomized&#xD;
Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message&#xD;
1) prior to their visit with the surgeon;&#xD;
2) at the time of their visit with the surgeon;&#xD;
3) after the surgeon appointment&#xD;
Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.&#xD;
Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Website</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After consent, the participant will be randomized&#xD;
Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message&#xD;
1) prior to their visit with the surgeon;&#xD;
2) at the time of their visit with the surgeon;&#xD;
3) after the surgeon appointment&#xD;
Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.&#xD;
Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinicians</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record&#xD;
Will complete pre-post trial survey about shared decision making</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breast Reconstruction Education and Support Tool (BREASTChoice)</intervention_name>
    <description>The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record</description>
    <arm_group_label>BREASTChoice</arm_group_label>
    <other_name>BREASTChoice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attention Control Website</intervention_name>
    <description>-(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)</description>
    <arm_group_label>Attention Control Website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinician Survey</intervention_name>
    <description>-Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.</description>
    <arm_group_label>Clinicians</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Diagnosis of incident or recurrent stage 0-III breast carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage IV breast carcinoma&#xD;
&#xD;
          -  Histology type besides ductal/obular carcinoma (e.g. phyllodes, sarcoma - these rare&#xD;
             tumors differ in treatment and prognosis)&#xD;
&#xD;
          -  Prior mastectomy and are seeking delayed breast reconstruction&#xD;
&#xD;
          -  No malignancy (i.e., considering mastectomy for prophylaxis only)&#xD;
&#xD;
          -  Cannot give informed consent or use provided study materials due to self-reported or&#xD;
             observed cognitive, visual, or emotional barriers&#xD;
&#xD;
        Inclusion Criteria for Clinicians:&#xD;
&#xD;
        -Clinicians who provide breast cancer care within the plastic and reconstructive surgery at&#xD;
        Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian&#xD;
        Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who&#xD;
        provide care for patients considering breast reconstruction after mastectomy&#xD;
&#xD;
        Exclusion Criteria for Clinicians:&#xD;
&#xD;
        -Plastic and reconstructive clinicians working at other breast clinic locations, and&#xD;
        surgeons who do provider breast reconstruction care to patients who have undergone a&#xD;
        mastectomy due to breast cancer&#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>Mary Politi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clara Lee, M.D., MPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University Wexner Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Breast Reconstruction</keyword>
  <keyword>Breast Reconstruction Education</keyword>
  <keyword>Breast Reconstruction Decision Tool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 19, 2023</submitted>
  </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/NCT04491591
org study id: 202005217
secondary id: R18HS026699
nct id: NCT04491591
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore
      quality of life for many, there are numerous risks associated with the procedure. The risk of
      complications exceeds that of most elective procedures. In past work, a clinical decision
      support tool, BREASTChoice, with personalized risk information and patient preferences, was
      created to be used to address these issues. It was modified with extensive stakeholder input
      and built to be incorporated into electronic health records and patient portals. This
      randomized control trial will evaluate whether the implementation of BREASTChoice into
      routine care delivery is more effective than a control website, at improving the quality of
      reconstruction decisions.
Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched
      to test the workflow and procedures. The investigators plan to recruit up to 20 patients,
      continuing until procedures are smooth and ready for the randomized trial. The investigators
      will follow these same procedures as the trial, other than randomization, to test the
      workflow and tool use programming.

      For the RCT, patients considering mastectomy at academic and community practices (n=340) will
      be randomized over 18 months to use BREASTChoice or a control website.

      After the patient participant consents to be in the study, they will be randomized (using
      computer random assignment) participants to view the clinical decision support tool,
      BREASTChoice or the attention control website, using block randomization (block size of 2 and
      4). Depending on the clinic work-flow, the patients may be sent the link to the tool or
      control website: 1) by email or MyChart message, prior to their visit with the plastic or
      reconstruction surgeon, for them to complete from home or in the waiting room (ideal and
      preferred approach); 2) by email or MyChart, in person or virtually at the time of their
      plastic or reconstruction visit, for patients that have same-day breast surgeon and plastic
      reconstruction surgeon visits, with time to wait in between appointments; or 3) by email or
      MyChart, after the plastic surgery appointment, if they have not yet made a decision about
      reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or
      they want or need more time to decide on their surgery choices). Participants will be sent
      the link via MyChart unless they do not have a MyChart account. In that case, they will be
      sent the link via email. Study staff will be available to answer questions about MyChart via
      phone or email.

      BREASTChoice is interactive with multiple modules. It starts with facts about breast
      reconstruction. Modules describe pros and cons of reconstruction, reconstruction timing, and
      reconstruction types. When discussing reconstruction timing, a risk prediction model pulls
      health data from the EHR (asking patients information in the model that is missing) to
      personalize risk of complications from immediate breast reconstruction. It also shows average
      risks for mastectomy alone and mastectomy plus immediate breast reconstruction so women can
      compare their personalized risk to average risks. Each module contains real patient quotes, a
      section called "Let's review" which checks patients' understanding, and "What matters to
      you", which elicits patients' preferences. Diverse patient photos and outcomes are provided.
      It is written at a 7th grade reading level. Data on patients' risks and a summary of her
      preferences are sent to their plastic/reconstructive surgeon to view in the electronic health
      record. The tool takes the patient about 20minutes to complete.

      Control Website: The investigators chose an attention control, rather than usual care, to
      reduce differences between arms in participant expectation of benefit. Those in the control
      arm will get a link to an NCI website about breast reconstruction. That website includes 10
      sections with information about types of breast reconstruction, timing, recovery, risks,
      cancer surveillance and additional resources. The website provides information, but does not
      include values clarification or tailored risk information. It is not interactive and does not
      include photos..

      (https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Knowledge as measured by Decision Quality Instrument
time frame: After initial visit but before surgery, estimated to be before day 7
description: -The validated Breast Reconstruction Decision Quality Instrument (DQI) knowledge scale contains 9 items on key facts about reconstruction. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items.
*For participant arms only
measure: Preference concordance as measured by the Decision Quality Instrument
time frame: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR
description: -The investigators will first estimate the patient's preferred treatment (mastectomy alone versus mastectomy with reconstruction), by inputting her values (entered into BREASTChoice or control survey) into a previously developed statistical model to compute her preferred treatment. The investigators will compare her preferred treatments to actual treatment received, with concordance determined by agreement between preferred and actual treatment received. The investigators will consider "actual treatment received" to be delayed reconstruction, if the patient states an intention to have delayed reconstruction, as she might not have started this process during the study.
*For participant arms only
measure: Decisional conflict as measured by the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale for decisional conflict
time frame: After initial visit but before surgery, estimated to be before day 7
description: -The validated, widely-used SURE measure of decisional conflict asks whether patients have enough information to make a choice, enough support to make a choice, and are clear about their values. It is a 4-item measure of yes/no questions (1=yes, 0=no). A score of ≤3 indicates decisional conflict.
*For participant arms only
measure: Compare number of high-risk participants from each arm who chose breast reconstruction
time frame: After patient participation (approximately 18 months)
description: -Participants will be considered high-risk if their risk exceeds two times the population average
measure: Provider intention to engage in shared decision making as measured by the change in the mean CPD (Continuing Professional Development)-Reaction scale
time frame: Assessed pre- and post-study (approximately 24 months)
description: -CPD Reaction scale is a 12-item measure, each item with a scale of 1-7. Measure change in mean response. Higher change in mean indicates behavior change. Constructs assessed include Intention, Social Influence, Beliefs about capabilities, Moral norm, and beliefs about consequence.
**For clinician arm only
measure: Knowledge as measured by knowledge questions developed in previous studies
time frame: After initial visit but before surgery, estimated before day 7
description: -This is an 11-item measure. A knowledge score will be calculated for each patient by dividing the number of correct responses by the number of knowledge items, using the approach described for the DQI
measure: Consult time as measured by time spent with clinician during the visit
time frame: Initial visit (day 1)
description: -Consult time using the BREASTChoice will be compared to consult using the attention control.
measure: Usability as measured by the system usability scale (SUS)
time frame: After initial visit but before surgery, estimated to be before day 7
description: -The SUS is a 10-item measure of how easy a website is to use. A usability score is calculated by adding the item and multiplied the sum by 2.5. Scores can range from 0-100 with higher scores indicating greater usability.
arm group label: BREASTChoice
arm group type: Experimental
description: After consent, the participant will be randomized
Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message
1) prior to their visit with the surgeon;
2) at the time of their visit with the surgeon;
3) after the surgeon appointment
Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website.
Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
arm group label: Attention Control Website
arm group type: Active Comparator
description: After consent, the participant will be randomized
Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message
1) prior to their visit with the surgeon;
2) at the time of their visit with the surgeon;
3) after the surgeon appointment
Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website.
Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
arm group label: Clinicians
arm group type: Experimental
description: Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record
Will complete pre-post trial survey about shared decision making
intervention type: Other
intervention name: Breast Reconstruction Education and Support Tool (BREASTChoice)
description: The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record
arm group label: BREASTChoice
other name: BREASTChoice
intervention type: Other
intervention name: Attention Control Website
description: -(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
arm group label: Attention Control Website
intervention type: Other
intervention name: Clinician Survey
description: -Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.
arm group label: Clinicians
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary Politi, Ph.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Clara Lee, M.D., MPP
role: Principal Investigator
affiliation: The Ohio State University Wexner Medical Center
facility: 
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
submitted: July 19, 2023