<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/NCT04496739</url>
  </required_header>
  <id_info>
    <org_study_id>S1904</org_study_id>
    <secondary_id>NCI-2019-08755</secondary_id>
    <secondary_id>S1904</secondary_id>
    <secondary_id>SWOG-S1904</secondary_id>
    <secondary_id>S1904</secondary_id>
    <secondary_id>R01CA226060</secondary_id>
    <secondary_id>UG1CA189974</secondary_id>
    <nct_id>NCT04496739</nct_id>
  </id_info>
  <brief_title>Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)</brief_title>
  <official_title>Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SWOG Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>SWOG Cancer Research Network</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 the implementation of web-based decision support tools for patients with&#xD;
      atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support&#xD;
      tools are designed to improve informed choice about breast cancer chemoprevention.&#xD;
      Recognizing barriers and facilitators that can influence the adoption of decision support&#xD;
      tools at recruitment centers may help researchers learn how to best implement them into&#xD;
      clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To compare the frequency of chemoprevention informed choice at 6 months after registration&#xD;
      among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the&#xD;
      intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard&#xD;
      educational materials) and control (standard educational materials alone) arms.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived&#xD;
      breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict&#xD;
      and decision regret at baseline, 6 months, and 12 months in the intervention and control&#xD;
      arms.&#xD;
&#xD;
      II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a&#xD;
      selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5&#xD;
      years between the intervention and control arms.&#xD;
&#xD;
      III. To assess shared decision-making about chemoprevention among patients and healthcare&#xD;
      providers after their 6-month clinic visit in the intervention and control arms.&#xD;
&#xD;
      IMPLEMENTATION OBJECTIVE:&#xD;
&#xD;
      I. To assess the implementation of the decision support tools, RealRisks and BNAV, into&#xD;
      clinic workflow, and to better understand barriers and facilitators to chemoprevention usage&#xD;
      by conducting telephone/video-conference interviews of healthcare providers and high-risk&#xD;
      women with AH or LCIS assigned to the active intervention.&#xD;
&#xD;
      OUTLINE: Recruitment centers are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk&#xD;
      and chemoprevention in RealRisks via the patient portal or website.&#xD;
&#xD;
      GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer&#xD;
      risk and chemoprevention in RealRisks via the patient portal or website. Patients receive&#xD;
      patient-centered decision support within the patient portal via an action plan summarizing&#xD;
      their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal&#xD;
      preferences for chemoprevention. Health care providers receive decision support and action&#xD;
      plans based on their patients' interactions with RealRisks via the BNAV provider-centered&#xD;
      support tool within the electronic health record (EHR). A sample of patients participate in&#xD;
      an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months&#xD;
      after registration. A sample of health care providers participate in 3 audio-recorded&#xD;
      interviews via telephone or video conference over 45-60 minutes each at baseline, within&#xD;
      12-36 months after study activation, and within 12 months after study closure to accrual.&#xD;
&#xD;
      After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 6, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chemoprevention informed choice</measure>
    <time_frame>At 6 months</time_frame>
    <description>Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approach to account for clustering. Additional supportive analyses will adjust for both patient and clinic level factors. If there are substantial missing data for the components of the primary endpoint, a sensitivity analysis will be conducted imputing a response of no informed decision making for those women with missing information.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived breast cancer risk</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be assessed by absolute estimate (&quot;How do you rate your chance of developing breast cancer?&quot;), comparative risk (&quot;Overall, how do you think your chance of developing breast cancer compares to the average woman your age?&quot;), and numeric risk (&quot;Please place an X on the line below at the point showing what you think your chance is of developing breast cancer in the next five years&quot;). All are assessed on a scale of 0% to 100%, with 0% as &quot;no chance of breast cancer&quot; and 100% as &quot;definitely will get breast cancer.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actual breast cancer risk score</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of risk perception</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). Categorized as: accurate if the difference between subjective and objective risk estimates are =&lt; 10% in either direction; underestimate if &gt; 10% below objective risk; and overestimate if &gt; 10% above objective risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cancer worry</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be measured by two Likert-style items, with responses ranging from &quot;Not at all&quot; (1) to &quot;All of the time&quot; (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision conflict</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision regret</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoprevention usage</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoprevention adherence</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for chemoprevention discontinuation</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shared decision-making</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">415</enrollment>
  <condition>Atypical Hyperplasia of the Breast</condition>
  <condition>Lobular Breast Carcinoma In Situ</condition>
  <condition>Pleomorphic Lobular Breast Carcinoma In Situ</condition>
  <arm_group>
    <arm_group_label>Group I (educational materials)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cancer Educational Materials</intervention_name>
    <description>Receive educational materials about breast cancer risk and chemoprevention via RealRisk</description>
    <arm_group_label>Group I (educational materials)</arm_group_label>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>Given patient-centered decision support via an action plan</description>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool</description>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Participate in audio-recorded interview via telephone or video conference</description>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (educational materials)</arm_group_label>
    <arm_group_label>Group II (educational materials, decision support, interview)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically-confirmed atypical hyperplasia (AH) or lobular&#xD;
             carcinoma in situ (LCIS) documented by breast pathology report at any time in the&#xD;
             past. Patients with borderline breast lesions and pleomorphic LCIS are also eligible&#xD;
&#xD;
          -  Patients must be women at least 35 and no more than 74 years of age at registration,&#xD;
             since the Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid only&#xD;
             for this age range&#xD;
&#xD;
          -  Both pre/perimenopausal and postmenopausal women are eligible&#xD;
&#xD;
          -  Patients must be able to read and write in English or Spanish since study&#xD;
             questionnaires and educational materials are only available in English and Spanish&#xD;
&#xD;
          -  Baseline questionnaires must be completed prior to patient registration&#xD;
&#xD;
          -  The S1904 Patient Contact form must be completed prior to patient registration&#xD;
&#xD;
          -  Patients must be able to access the internet and receive email or text messages. This&#xD;
             is required to access study materials and receive email/text message reminders from&#xD;
             the S1904 Study Team at Columbia University Irving Medical Center (CUIMC). The patient&#xD;
             decision aid, RealRisks, is accessible via smartphones, tablets, or personal&#xD;
             computers. If patients do not own these devices, local study personnel will provide&#xD;
             resources for patients to access RealRisks via computer kiosks or tablets in clinic&#xD;
             waiting rooms or public locations, such as community centers or public libraries&#xD;
&#xD;
          -  Patients and healthcare providers must be informed of the investigational nature of&#xD;
             this study and must sign and give written informed consent in accordance with&#xD;
             institutional and federal guidelines&#xD;
&#xD;
          -  As a part of the Oncology Patient Enrollment Network (OPEN) registration process the&#xD;
             treating institution's identity is provided in order to ensure that the current&#xD;
             (within 365 days) date of institutional review board approval for this study has been&#xD;
             entered in the system&#xD;
&#xD;
          -  IMPLEMENTATION: Providers who enrolled in S1904 at Group 2 (intervention) recruitment&#xD;
             center and consented to future contact are eligible to participate in the interviews&#xD;
&#xD;
          -  IMPLEMENTATION EVALUATION: Patients who registered to S1904 at a Group 2&#xD;
             (Intervention) Recruitment Center and consented to be contacted for future research&#xD;
             are eligible to participate in the interviews&#xD;
&#xD;
          -  Recruitment Centers must be National Clinical Trials Network (NCTN), National Cancer&#xD;
             Institute Community Oncology Research Program (NCORP) or Minority Underserved&#xD;
             (MU)-NCORP institutions&#xD;
&#xD;
          -  Recruitment Centers must have an active EHR and patient portal used in the outpatient&#xD;
             clinics which is common and accessible across all sites belonging to the Recruitment&#xD;
             Center&#xD;
&#xD;
          -  Recruitment Centers must be willing to allow the S1904 study team access to the site's&#xD;
             application program interface (API) for integration of the study materials (standard&#xD;
             educational materials and decision support tools) into the EHR and patient portal.&#xD;
             (NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centers may&#xD;
             access the standard educational materials via the patient portal or uniform resource&#xD;
             locator (URL)/website)&#xD;
&#xD;
          -  Recruitment centers must see at least 50 AH and/or LCIS patients per year&#xD;
&#xD;
          -  Recruitment centers must identify a lead principal investigator (PI) to facilitate&#xD;
             recruitment and retention of patients and healthcare providers and to participate in&#xD;
             quarterly stakeholder meetings/conference calls&#xD;
&#xD;
          -  Recruitment centers must be willing to register at about 16 patients and 5 healthcare&#xD;
             providers to the study&#xD;
&#xD;
          -  Recruitment Centers must be willing to submit monthly screening logs to CUIMC&#xD;
&#xD;
          -  Providers must regularly see patients with AH or LCIS at an approved recruitment&#xD;
             center&#xD;
&#xD;
          -  Providers must be willing to provide informed consent and complete an online baseline&#xD;
             questionnaire&#xD;
&#xD;
          -  Providers who will register patients must be registered members of a Cooperative Group&#xD;
&#xD;
          -  Providers who register patients to S1904 must be willing to see those same patients&#xD;
             for their 6-month study visits, as the provider intervention tools require that the&#xD;
             &quot;treating investigator&quot; as designated in OPEN and the provider at the 6-month study&#xD;
             visit be the same&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must not have a history of invasive breast cancer or ductal carcinoma in situ&#xD;
&#xD;
          -  Patients must not have prior or current use of selective estrogen receptor modulators&#xD;
             (SERMs) or aromatase inhibitors (AIs)&#xD;
&#xD;
               -  NOTE: The following are approved SERMS and AIs, however, the study is not limited&#xD;
                  to these.&#xD;
&#xD;
                    -  SERMs: tamoxifen, raloxifene&#xD;
&#xD;
                    -  AIs: anastrozole, exemestane, letrozole&#xD;
&#xD;
          -  Patients must not be currently taking hormone replacement therapy&#xD;
&#xD;
          -  Patients must not have a history of bilateral mastectomies or breast implants since&#xD;
             the risk calculator is not applicable to these women&#xD;
&#xD;
          -  Patients must not be pregnant or lactating&#xD;
&#xD;
          -  Premenopausal patients must not have a history of thromboembolism, since it is a&#xD;
             contraindication to tamoxifen. Tamoxifen is the only Food and Drug Administration&#xD;
             (FDA)-approved drug for breast cancer chemoprevention among high-risk premenopausal&#xD;
             women, whereas postmenopausal women are eligible for both SERMs and AIs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine D Crew</last_name>
    <role>Principal Investigator</role>
    <affiliation>SWOG Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente-Deer Valley Medical Center</name>
      <address>
        <city>Antioch</city>
        <state>California</state>
        <zip>94531</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Irvine Health Cancer Center-Newport</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92627</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-826-4673</phone>
      <email>becomingapatient@coh.org</email>
    </contact>
    <investigator>
      <last_name>Lisa D. Yee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>UC Irvine Health/Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Downtown Commons</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-South Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser San Rafael-Gallinas</name>
      <address>
        <city>San Rafael</city>
        <state>California</state>
        <zip>94903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope South Pasadena</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-826-4673</phone>
      <email>becomingapatient@coh.org</email>
    </contact>
    <investigator>
      <last_name>Lisa D. Yee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-South San Francisco</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Vallejo</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94589</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Walnut Creek</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Samantha A. Seaward</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Comprehensive Cancer Center at Aventura</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>305-674-2625</phone>
      <email>yenrique@msmc.com</email>
    </contact>
    <investigator>
      <last_name>Ragisha Gopalakrishnan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>305-674-2625</phone>
      <email>yenrique@msmc.com</email>
    </contact>
    <investigator>
      <last_name>Ragisha Gopalakrishnan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>786-596-2000</phone>
    </contact>
    <investigator>
      <last_name>Ana C. Sandoval Leon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute at Plantation</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>954-837-1490</phone>
    </contact>
    <investigator>
      <last_name>Ana C. Sandoval Leon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-489-9164</phone>
    </contact>
    <investigator>
      <last_name>Cathy L. Graham</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-946-7447</phone>
    </contact>
    <investigator>
      <last_name>Cathy L. Graham</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-778-1868</phone>
    </contact>
    <investigator>
      <last_name>Cathy L. Graham</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-851-7115</phone>
    </contact>
    <investigator>
      <last_name>Cathy L. Graham</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care - Westridge</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-539-2273</phone>
      <email>info@hawaiicancercare.com</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-486-6000</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-487-7447</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-678-9000</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Queen's Medical Center - West Oahu</name>
      <address>
        <city>'Ewa Beach</city>
        <state>Hawaii</state>
        <zip>96706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>rohta@queens.org</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-524-6115</phone>
      <email>i.webster@hawaiicancercare.com</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-532-0315</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-545-8548</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-522-4333</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-586-2979</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hawaii Diagnostic Radiology Services LLC</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-792-7897</phone>
      <email>mmiyoshi@hawaiidrs.com</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kuakini Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-547-9816</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-531-8521</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-547-6881</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-983-6090</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Straub Medical Center - Kahului Clinic</name>
      <address>
        <city>Kahului</city>
        <state>Hawaii</state>
        <zip>96732</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>lori.kam@hawaiipacifichealth.org</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Castle Medical Center</name>
      <address>
        <city>Kailua</city>
        <state>Hawaii</state>
        <zip>96734</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>protocols@swog.org</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-535-7960</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola Center for Health at Burr Ridge</name>
      <address>
        <city>Burr Ridge</city>
        <state>Illinois</state>
        <zip>60527</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>708-216-9000</phone>
    </contact>
    <investigator>
      <last_name>Shelly S. Lo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centralia Oncology Clinic</name>
      <address>
        <city>Centralia</city>
        <state>Illinois</state>
        <zip>62801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4762</phone>
      <email>morganthaler.jodi@mhsil.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advocate Illinois Masonic Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-296-5360</phone>
    </contact>
    <investigator>
      <last_name>Thomas J. Saphner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle at The Riverfront</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@Carle.com</email>
    </contact>
    <investigator>
      <last_name>Maria T. Grosse-Perdekamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4762</phone>
      <email>morganthaler.jodi@mhsil.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Maria T. Grosse-Perdekamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4762</phone>
      <email>morganthaler.jodi@mhsil.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Maria T. Grosse-Perdekamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>708-226-4357</phone>
    </contact>
    <investigator>
      <last_name>Shelly S. Lo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Care Center of O'Fallon</name>
      <address>
        <city>O'Fallon</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4762</phone>
      <email>morganthaler.jodi@mhsil.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>847-384-3621</phone>
    </contact>
    <investigator>
      <last_name>Thomas J. Saphner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Maria T. Grosse-Perdekamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>IU Health West Hospital</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-278-5632</phone>
      <email>iutrials@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Tarah J. Ballinger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IU Health North Hospital</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-278-5632</phone>
      <email>iutrials@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Tarah J. Ballinger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Indiana University/Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-278-5632</phone>
      <email>iutrials@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Tarah J. Ballinger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sidney and Lois Eskenazi Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-278-5632</phone>
      <email>iutrials@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Tarah J. Ballinger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beverly Hospital</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>978-922-3000</phone>
      <phone_ext>2405</phone_ext>
    </contact>
    <investigator>
      <last_name>Corrine L. Zarwan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-442-3324</phone>
    </contact>
    <investigator>
      <last_name>Tari A. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital and Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>781-744-3421</phone>
      <email>lhmc-cancer-clinical-trials@lahey.org</email>
    </contact>
    <investigator>
      <last_name>Corrine L. Zarwan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Addison Gilbert Hospital</name>
      <address>
        <city>Gloucester</city>
        <state>Massachusetts</state>
        <zip>01930</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>978-283-4000</phone>
      <phone_ext>559</phone_ext>
    </contact>
    <investigator>
      <last_name>Corrine L. Zarwan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Winchester Hospital</name>
      <address>
        <city>Winchester</city>
        <state>Massachusetts</state>
        <zip>01890</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>protocols@swog.org</email>
    </contact>
    <investigator>
      <last_name>Corrine L. Zarwan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Michigan Cancer Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Borgess Medical Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Sandhya Pruthi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-305-6361</phone>
      <email>nr2616@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Katherine D. Crew</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Giacomo Montagna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>701-234-6161</phone>
      <email>OncologyClinicalTrialsFargo@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Preston D. Steen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-293-5066</phone>
      <email>Jamesline@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Doreen M. Agnese</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>541-768-4352</phone>
      <email>stmock@samhealth.org</email>
    </contact>
    <investigator>
      <last_name>Rachel Shirley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Charles W. Drescher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Saint Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Charles W. Drescher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Holy Redeemer Hospital and Medical Center</name>
      <address>
        <city>Meadowbrook</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-938-3551</phone>
    </contact>
    <investigator>
      <last_name>Stacy L. Krisher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicTrialsSF@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Preston D. Steen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital and Cancer Center-Collierville</name>
      <address>
        <city>Collierville</city>
        <state>Tennessee</state>
        <zip>38017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>901-226-1366</phone>
      <email>BCCclintrials@bmhcc.org</email>
    </contact>
    <investigator>
      <last_name>Lindi H. VanderWalde</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital and Cancer Center-Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>901-226-1366</phone>
      <email>BCCclintrials@bmhcc.org</email>
    </contact>
    <investigator>
      <last_name>Lindi H. VanderWalde</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital for Women</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>901-226-1366</phone>
      <email>BCCclintrials@bmhcc.org</email>
    </contact>
    <investigator>
      <last_name>Lindi H. VanderWalde</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-424-2100</phone>
      <email>cancerinfo@hci.utah.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah V. Colonna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute-Newport News</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>757-534-6863</phone>
      <email>casey.morris@rivhs.com</email>
    </contact>
    <investigator>
      <last_name>Masey M. Ross</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ctoclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Masey M. Ross</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Masey M. Ross</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>VCU Community Memorial Health Center</name>
      <address>
        <city>South Hill</city>
        <state>Virginia</state>
        <zip>23970</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>nemer.elmouallem@vcuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Masey M. Ross</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shenandoah Oncology PC</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System-Eau Claire Clinic</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Sandhya Pruthi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-622-8922</phone>
    </contact>
    <investigator>
      <last_name>Kari B. Wisinski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Thomas J. Saphner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vince Lombardi Cancer Clinic-Two Rivers</name>
      <address>
        <city>Two Rivers</city>
        <state>Wisconsin</state>
        <zip>54241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Thomas J. Saphner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora West Allis Medical Center</name>
      <address>
        <city>West Allis</city>
        <state>Wisconsin</state>
        <zip>53227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Thomas J. Saphner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>FHP Health Center-Guam</name>
      <address>
        <city>Tamuning</city>
        <zip>96913</zip>
        <country>Guam</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location_countries>
    <country>Guam</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
    <mesh_term>Hyperplasia</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/NCT04496739
org study id: S1904
secondary id: NCI-2019-08755
secondary id: S1904
secondary id: SWOG-S1904
secondary id: S1904
secondary id: R01CA226060
secondary id: UG1CA189974
nct id: NCT04496739
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial studies the implementation of web-based decision support tools for patients with
      atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support
      tools are designed to improve informed choice about breast cancer chemoprevention.
      Recognizing barriers and facilitators that can influence the adoption of decision support
      tools at recruitment centers may help researchers learn how to best implement them into
      clinical practice.
PRIMARY OBJECTIVE:

      I. To compare the frequency of chemoprevention informed choice at 6 months after registration
      among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the
      intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard
      educational materials) and control (standard educational materials alone) arms.

      SECONDARY OBJECTIVES:

      I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived
      breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict
      and decision regret at baseline, 6 months, and 12 months in the intervention and control
      arms.

      II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a
      selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5
      years between the intervention and control arms.

      III. To assess shared decision-making about chemoprevention among patients and healthcare
      providers after their 6-month clinic visit in the intervention and control arms.

      IMPLEMENTATION OBJECTIVE:

      I. To assess the implementation of the decision support tools, RealRisks and BNAV, into
      clinic workflow, and to better understand barriers and facilitators to chemoprevention usage
      by conducting telephone/video-conference interviews of healthcare providers and high-risk
      women with AH or LCIS assigned to the active intervention.

      OUTLINE: Recruitment centers are randomized to 1 of 2 groups.

      GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk
      and chemoprevention in RealRisks via the patient portal or website.

      GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer
      risk and chemoprevention in RealRisks via the patient portal or website. Patients receive
      patient-centered decision support within the patient portal via an action plan summarizing
      their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal
      preferences for chemoprevention. Health care providers receive decision support and action
      plans based on their patients' interactions with RealRisks via the BNAV provider-centered
      support tool within the electronic health record (EHR). A sample of patients participate in
      an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months
      after registration. A sample of health care providers participate in 3 audio-recorded
      interviews via telephone or video conference over 45-60 minutes each at baseline, within
      12-36 months after study activation, and within 12 months after study closure to accrual.

      After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Chemoprevention informed choice
time frame: At 6 months
description: Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approach to account for clustering. Additional supportive analyses will adjust for both patient and clinic level factors. If there are substantial missing data for the components of the primary endpoint, a sensitivity analysis will be conducted imputing a response of no informed decision making for those women with missing information.
measure: Perceived breast cancer risk
time frame: Up to 12 months
description: Will be assessed by absolute estimate ("How do you rate your chance of developing breast cancer?"), comparative risk ("Overall, how do you think your chance of developing breast cancer compares to the average woman your age?"), and numeric risk ("Please place an X on the line below at the point showing what you think your chance is of developing breast cancer in the next five years"). All are assessed on a scale of 0% to 100%, with 0% as "no chance of breast cancer" and 100% as "definitely will get breast cancer."
measure: Actual breast cancer risk score
time frame: Up to 12 months
description: A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.
measure: Accuracy of risk perception
time frame: Up to 12 months
description: Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). Categorized as: accurate if the difference between subjective and objective risk estimates are =< 10% in either direction; underestimate if > 10% below objective risk; and overestimate if > 10% above objective risk.
measure: Breast cancer worry
time frame: Up to 12 months
description: Will be measured by two Likert-style items, with responses ranging from "Not at all" (1) to "All of the time" (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.
measure: Decision conflict
time frame: Up to 12 months
description: Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.
measure: Decision regret
time frame: Up to 12 months
description: Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.
measure: Chemoprevention usage
time frame: Up to 5 years
description: Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.
measure: Chemoprevention adherence
time frame: Up to 5 years
description: Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
measure: Reasons for chemoprevention discontinuation
time frame: Up to 5 years
description: For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
measure: Shared decision-making
time frame: Up to 6 months
description: Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.
arm group label: Group I (educational materials)
arm group type: Active Comparator
description: Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
arm group label: Group II (educational materials, decision support, interview)
arm group type: Experimental
description: Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.
intervention type: Behavioral
intervention name: Cancer Educational Materials
description: Receive educational materials about breast cancer risk and chemoprevention via RealRisk
arm group label: Group I (educational materials)
arm group label: Group II (educational materials, decision support, interview)
intervention type: Other
intervention name: Decision Aid
description: Given patient-centered decision support via an action plan
arm group label: Group II (educational materials, decision support, interview)
intervention type: Other
intervention name: Decision Aid
description: Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool
arm group label: Group II (educational materials, decision support, interview)
intervention type: Other
intervention name: Interview
description: Participate in audio-recorded interview via telephone or video conference
arm group label: Group II (educational materials, decision support, interview)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (educational materials)
arm group label: Group II (educational materials, decision support, interview)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine D Crew
role: Principal Investigator
affiliation: SWOG Cancer Research Network
facility: 
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country: Guam
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma in Situ
mesh term: Breast Carcinoma In Situ
mesh term: Carcinoma, Lobular
mesh term: Hyperplasia