<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/NCT03766009</url>
  </required_header>
  <id_info>
    <org_study_id>A231701CD</org_study_id>
    <secondary_id>NCI-2018-00643</secondary_id>
    <nct_id>NCT03766009</nct_id>
  </id_info>
  <brief_title>Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making</brief_title>
  <official_title>Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for Clinical Trials in Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well a breast cancer surgery decision aid works in increasing patient&#xD;
      engagement in decision making for patients with newly diagnosed stage 0-III breast cancer.&#xD;
      The trial also examines barriers to patient engagement even with the use of a decision aid,&#xD;
      and if barriers are more likely to be experienced by socioeconomically disadvantaged&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary and secondary objectives of the study:&#xD;
&#xD;
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient&#xD;
      engagement in decision making (measured by knowledge and power) in clinics serving a high&#xD;
      proportion of socioeconomically disadvantaged patients.&#xD;
&#xD;
      II. Test the extent to which the effect of a decision aid on patient engagement is mediated&#xD;
      through the mitigation of barriers and determine if persistent barriers are&#xD;
      disproportionately experienced by socioeconomically disadvantaged patients.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Characterize how persistent barriers influence patient engagement in decision making in&#xD;
      order to identify targets for adjunct interventions that could be implemented in clinics&#xD;
      serving a high proportion of socioeconomically disadvantaged patients.&#xD;
&#xD;
      Trial Design:&#xD;
&#xD;
      OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten&#xD;
      clinics will be recruited for participation. All clinics will begin in the usual care arm.&#xD;
      Clinics will be randomized to the timing with which they cross-over to the decision aid&#xD;
      intervention, with new clinics crossing over every 10 weeks.&#xD;
&#xD;
      ARM I: usual care&#xD;
&#xD;
      ARM II: decision aid intervention&#xD;
&#xD;
      The only difference between patients enrolled before institutional crossover and patients&#xD;
      enrolled after institutional crossover is those who are enrolled after institutional&#xD;
      crossover will have been offered the decision aid as accepted practice in the clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Actual">January 26, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Institutional cross-over</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient power: self-efficacy in patient physician interactions</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient power: active patient participation</measure>
    <time_frame>1 day</time_frame>
    <description>Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by a third party and represents a count of patients' communicative behaviors ranging from 0-99, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient knowledge</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance between personal values and surgery received</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">598</enrollment>
  <condition>Breast Cancer Stage 0</condition>
  <condition>Breast Cancer Stage I</condition>
  <condition>Breast Cancer Stage II</condition>
  <condition>Breast Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>Arm I (surgical consultation)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prior to institutional crossover, participants receive care as per usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (web-based breast cancer surgery decision aid)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual Care</description>
    <arm_group_label>Arm I (surgical consultation)</arm_group_label>
    <arm_group_label>Arm II (web-based breast cancer surgery decision aid)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web-based decision aid</intervention_name>
    <description>Web-based decision aid received prior to the surgical consultation</description>
    <arm_group_label>Arm II (web-based breast cancer surgery decision aid)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with stage 0-III breast cancer&#xD;
&#xD;
          -  Eligible patients must be planning breast surgery as a component of their definitive&#xD;
             treatment&#xD;
&#xD;
          -  Patients with impaired decision-making capacity (such as with a diagnosis of dementia&#xD;
             or memory loss) are not eligible for this study&#xD;
&#xD;
          -  Patients with hearing impairment requiring the use of an interpreter are not eligible&#xD;
             for this study&#xD;
&#xD;
          -  Patients must be able to speak English with the fluency required to have a direct&#xD;
             discussion around treatment decision-making (i.e. without interpreter)&#xD;
&#xD;
          -  CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff,&#xD;
             medical assistant, or mid-level provider at each participating clinic who participates&#xD;
             in the care of patients newly diagnosed with breast cancer&#xD;
&#xD;
          -  INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients&#xD;
             newly diagnosed with breast cancer will be selected to participate in this study&#xD;
&#xD;
          -  INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement&#xD;
             for site participation&#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>Heather B. Neuman,, MD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Epic Care-Dublin</name>
      <address>
        <city>Dublin</city>
        <state>California</state>
        <zip>94568</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Breast Surgeons Inc</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Partners in Cancer Care</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Contra Costa Regional Medical Center</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553-3156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Summit Medical Center - Summit Campus</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Tumor Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Cyberknife Center</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care - Savio</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pali Momi Medical Center</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Center - Pearlridge</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Pali Momi</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care Inc - Waterfront Plaza</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Urology</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Cenrer - POB I</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Straub Clinic and Hospital</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care Inc-Liliha</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuakini Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Center - Kuakini</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Liliha</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilcox Memorial Hospital and Kauai Medical Clinic</name>
      <address>
        <city>Lihue</city>
        <state>Hawaii</state>
        <zip>96766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Caldwell</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Health - Coeur d'Alene</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Knox Memorial Hospital</name>
      <address>
        <city>Emmett</city>
        <state>Idaho</state>
        <zip>83617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute-Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Clinic Cancer Services - Post Falls</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Cancer Clinic</name>
      <address>
        <city>Sandpoint</city>
        <state>Idaho</state>
        <zip>83864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John H Stroger Jr Hospital of Cook County</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle on Vermilion</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Anaconda</name>
      <address>
        <city>Anaconda</city>
        <state>Montana</state>
        <zip>59711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Falls Clinic</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Peter's Community Hospital</name>
      <address>
        <city>Helena</city>
        <state>Montana</state>
        <zip>59601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kalispell Regional Medical Center</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Baker City</name>
      <address>
        <city>Baker City</city>
        <state>Oregon</state>
        <zip>97814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Ontario</name>
      <address>
        <city>Ontario</city>
        <state>Oregon</state>
        <zip>97914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center at Stony Point</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic-Cody</name>
      <address>
        <city>Cody</city>
        <state>Wyoming</state>
        <zip>82414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welch Cancer Center</name>
      <address>
        <city>Sheridan</city>
        <state>Wyoming</state>
        <zip>82801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FHP Health Center-Guam</name>
      <address>
        <city>Tamuning</city>
        <zip>96913</zip>
        <country>Guam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pan American Center for Oncology Trials LLC</name>
      <address>
        <city>San Juan</city>
        <zip>00902</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guam</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</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>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Beginning 6 to 12 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;) identified for this purpose.</ipd_access_criteria>
    <ipd_url>https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FDatasharing</ipd_url>
  </patient_data>
  <!-- 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/NCT03766009
org study id: A231701CD
secondary id: NCI-2018-00643
nct id: NCT03766009
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial studies how well a breast cancer surgery decision aid works in increasing patient
      engagement in decision making for patients with newly diagnosed stage 0-III breast cancer.
      The trial also examines barriers to patient engagement even with the use of a decision aid,
      and if barriers are more likely to be experienced by socioeconomically disadvantaged
      patients.
The primary and secondary objectives of the study:

      PRIMARY OBJECTIVES:

      I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient
      engagement in decision making (measured by knowledge and power) in clinics serving a high
      proportion of socioeconomically disadvantaged patients.

      II. Test the extent to which the effect of a decision aid on patient engagement is mediated
      through the mitigation of barriers and determine if persistent barriers are
      disproportionately experienced by socioeconomically disadvantaged patients.

      SECONDARY OBJECTIVES:

      I. Characterize how persistent barriers influence patient engagement in decision making in
      order to identify targets for adjunct interventions that could be implemented in clinics
      serving a high proportion of socioeconomically disadvantaged patients.

      Trial Design:

      OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten
      clinics will be recruited for participation. All clinics will begin in the usual care arm.
      Clinics will be randomized to the timing with which they cross-over to the decision aid
      intervention, with new clinics crossing over every 10 weeks.

      ARM I: usual care

      ARM II: decision aid intervention

      The only difference between patients enrolled before institutional crossover and patients
      enrolled after institutional crossover is those who are enrolled after institutional
      crossover will have been offered the decision aid as accepted practice in the clinic.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Institutional cross-over
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient power: self-efficacy in patient physician interactions
time frame: Up to 3 weeks
description: Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
measure: Patient power: active patient participation
time frame: 1 day
description: Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by a third party and represents a count of patients' communicative behaviors ranging from 0-99, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
measure: Patient knowledge
time frame: Up to 3 weeks
description: Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
measure: Concordance between personal values and surgery received
time frame: Up to 3 weeks
description: This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.
arm group label: Arm I (surgical consultation)
arm group type: Active Comparator
description: Prior to institutional crossover, participants receive care as per usual care.
arm group label: Arm II (web-based breast cancer surgery decision aid)
arm group type: Experimental
description: Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
intervention type: Other
intervention name: Usual Care
description: Usual Care
arm group label: Arm I (surgical consultation)
arm group label: Arm II (web-based breast cancer surgery decision aid)
intervention type: Other
intervention name: Web-based decision aid
description: Web-based decision aid received prior to the surgical consultation
arm group label: Arm II (web-based breast cancer surgery decision aid)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heather B. Neuman,, MD, MS
role: Study Chair
affiliation: University of Wisconsin, Madison
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country: Guam
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Carcinoma In Situ
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Beginning 6 to 12 months following article publication.
ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
ipd url: https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FDatasharing