<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/NCT03304002</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0588</org_study_id>
    <secondary_id>A539740</secondary_id>
    <secondary_id>SMPH\SURGERY\GEN SURG</secondary_id>
    <secondary_id>5P30CA014520-43</secondary_id>
    <secondary_id>UW16147</secondary_id>
    <secondary_id>Protocol Version 3/15/2019</secondary_id>
    <nct_id>NCT03304002</nct_id>
  </id_info>
  <brief_title>Implementation of a Web-based Decision Aid for Breast Cancer Surgery</brief_title>
  <official_title>Implementation of a Web-based Decision Aid for Breast Cancer Surgery: Adapting to the Needs of Diverse Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</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 Wisconsin, Madison</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Routine incorporation of decision aids into oncology practice has the potential to&#xD;
      significantly improve patients' experiences with cancer by increasing the likelihood that&#xD;
      they make informed treatment decisions aligned with their values. Unfortunately, only a&#xD;
      minority of the more than 1.6 million patients diagnosed annually with cancer ever receive&#xD;
      one due to limited clinic resources for administration and challenges in timely&#xD;
      identification of appropriate patients. Online delivery directly to patients addresses some&#xD;
      of these barriers but is insufficient on its own to ensure accessibility for patients at the&#xD;
      time they most benefit from support.19 It is critical that active, multi-faceted&#xD;
      implementation strategies that target barriers to the widespread use of web-based decision&#xD;
      aids be identified, as these tools have the potential to significantly improve the quality of&#xD;
      oncologic care.&#xD;
&#xD;
      Based on strong preliminary work, the investigators have developed and piloted a package of&#xD;
      implementation strategies that effectively overcomes barriers to delivery of a web-based&#xD;
      breast cancer surgery decision aid in an academic and community clinic. Although the strategy&#xD;
      was successful, patients were white and educated; further investigation is imperative in&#xD;
      settings that provide care to underserved patients to ensure the intervention will mitigate,&#xD;
      rather than worsen, existing disparities in breast cancer care. This is especially critical&#xD;
      given that underserved patients may benefit most from shared decision-making interventions&#xD;
      such as the one described. To study this, the investigators propose a pilot study within a&#xD;
      clinic that serves a catchment area with a high proportion of African American, rural and low&#xD;
      income patients. The investigators will iteratively assess and enhance our implementation&#xD;
      package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local&#xD;
      context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient&#xD;
      and clinic level barriers to implementation of a web-based breast cancer surgery decision aid&#xD;
      in a clinic that cares for underserved patients, and 2) To test and expand our current&#xD;
      implementation package's ability to address barriers in a clinic that cares for underserved&#xD;
      patients. The investigators will determine the reach of implementation and acceptability of&#xD;
      this method of decision aid delivery to stakeholders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Actual">May 12, 2020</completion_date>
  <primary_completion_date type="Actual">May 12, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reach: Proportion of Participants who Utilize the Decision Aid</measure>
    <time_frame>measured over the 4 month implementation period</time_frame>
    <description>Reach of the implementation is defined as the proportion of participants over the four month implementation period who: 1) are sent the decision aid and 2) access the decision aid.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email</measure>
    <time_frame>Survey sent within 4 weeks of surgical consultation</time_frame>
    <description>acceptability will be defined as &gt;80% of patients reporting they would recommend receiving breast cancer information via email to others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers and Facilitators to Implementation of the Decision Aid</measure>
    <time_frame>Interviewed completed within 6 months of the surgical consultation</time_frame>
    <description>One-on-one interviews with participants to identify those who experienced barriers and facilitators to implementing the decision aid</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breast Cancer Surgery Decision Aid</intervention_name>
    <description>We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a clinic-level intervention with two stakeholder groups: (1) clinical staff, clinic&#xD;
        leadership, and surgeons involved in implementation, and (2) patients newly diagnosed with&#xD;
        Stage 0-3 breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients newly diagnosed with Stage 0-3 breast cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
        Clinic Stakeholders:&#xD;
&#xD;
        Inclusion Criteria: clinical staff, clinic leadership, and surgeons involved in&#xD;
        implementation Exclusion Criteria: none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Neuman</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Health System</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>May 23, 2021</last_update_submitted>
  <last_update_submitted_qc>May 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</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>Breast Neoplasms</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/NCT03304002
org study id: 2017-0588
secondary id: A539740
secondary id: SMPH\SURGERY\GEN SURG
secondary id: 5P30CA014520-43
secondary id: UW16147
secondary id: Protocol Version 3/15/2019
nct id: NCT03304002
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Routine incorporation of decision aids into oncology practice has the potential to
      significantly improve patients' experiences with cancer by increasing the likelihood that
      they make informed treatment decisions aligned with their values. Unfortunately, only a
      minority of the more than 1.6 million patients diagnosed annually with cancer ever receive
      one due to limited clinic resources for administration and challenges in timely
      identification of appropriate patients. Online delivery directly to patients addresses some
      of these barriers but is insufficient on its own to ensure accessibility for patients at the
      time they most benefit from support.19 It is critical that active, multi-faceted
      implementation strategies that target barriers to the widespread use of web-based decision
      aids be identified, as these tools have the potential to significantly improve the quality of
      oncologic care.

      Based on strong preliminary work, the investigators have developed and piloted a package of
      implementation strategies that effectively overcomes barriers to delivery of a web-based
      breast cancer surgery decision aid in an academic and community clinic. Although the strategy
      was successful, patients were white and educated; further investigation is imperative in
      settings that provide care to underserved patients to ensure the intervention will mitigate,
      rather than worsen, existing disparities in breast cancer care. This is especially critical
      given that underserved patients may benefit most from shared decision-making interventions
      such as the one described. To study this, the investigators propose a pilot study within a
      clinic that serves a catchment area with a high proportion of African American, rural and low
      income patients. The investigators will iteratively assess and enhance our implementation
      package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local
      context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient
      and clinic level barriers to implementation of a web-based breast cancer surgery decision aid
      in a clinic that cares for underserved patients, and 2) To test and expand our current
      implementation package's ability to address barriers in a clinic that cares for underserved
      patients. The investigators will determine the reach of implementation and acceptability of
      this method of decision aid delivery to stakeholders.
observational model: Cohort
time perspective: Prospective
measure: Reach: Proportion of Participants who Utilize the Decision Aid
time frame: measured over the 4 month implementation period
description: Reach of the implementation is defined as the proportion of participants over the four month implementation period who: 1) are sent the decision aid and 2) access the decision aid.
measure: Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email
time frame: Survey sent within 4 weeks of surgical consultation
description: acceptability will be defined as >80% of patients reporting they would recommend receiving breast cancer information via email to others.
measure: Barriers and Facilitators to Implementation of the Decision Aid
time frame: Interviewed completed within 6 months of the surgical consultation
description: One-on-one interviews with participants to identify those who experienced barriers and facilitators to implementing the decision aid
intervention type: Other
intervention name: Breast Cancer Surgery Decision Aid
description: We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Heather Neuman
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms