<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/NCT03283553</url>
  </required_header>
  <id_info>
    <org_study_id>J1735</org_study_id>
    <secondary_id>IRB00129995</secondary_id>
    <secondary_id>SAC170001</secondary_id>
    <nct_id>NCT03283553</nct_id>
  </id_info>
  <brief_title>Involving Family to Improve Communication in Breast Cancer Care</brief_title>
  <official_title>Involving Family to Improve Communication in Breast Cancer Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Susan G. Komen Breast Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates a multi-component communication intervention in the outpatient setting&#xD;
      to strengthen communication among patients being actively treated for breast cancer and their&#xD;
      support network of family members and friends. The intervention comprises: 1.) a&#xD;
      patient-family agenda-setting checklist completed immediately before a regularly scheduled&#xD;
      oncology visit, 2.) facilitated registration for the patient portal (for patient and family&#xD;
      member, as desired by the patient), and 3.) education (as relevant) on access to clinician&#xD;
      electronic visit notes. The study team will conduct a two-group randomized trial to examine&#xD;
      feasibility of the protocol and to compare quality of communication with oncology providers,&#xD;
      understanding of patient's cancer, confidence in managing patient's care and satisfaction&#xD;
      with cancer care between patient-companion dyads who are in the intervention group (n=60) and&#xD;
      patient-companion dyads who receive usual medical oncology care (n=60).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the most common cancer among survivors in the US. Most patients with breast&#xD;
      cancer receive help from family in making complex decisions about treatment, handling&#xD;
      logistically demanding care coordination, and managing symptoms and side effects. Although&#xD;
      family members (as defined by each patient) play a vital role in cancer care, they are not&#xD;
      formally recognized or assessed in care delivery, and their need for information and support&#xD;
      is typically unmet. Lack of attention to family in care delivery is an important gap that too&#xD;
      often leaves families without adequate information about patient health and treatments. This&#xD;
      may prevent families and patients from engaging in open conversations, cause them unnecessary&#xD;
      anxiety, and negatively affect the quality of cancer care and delivery.&#xD;
&#xD;
      Communication is particularly important in cancer care, as the optimal course of action is&#xD;
      determined through longitudinal discussion of prognosis, treatments, and patient goals,&#xD;
      preferences, and concerns. Strategies to improve communication for serious illnesses such as&#xD;
      cancer have been developed, but typically target a specific decision, conversation, or&#xD;
      setting, most often the inpatient hospital. There is growing agreement that communication&#xD;
      among patients, families, and providers should be initiated early and continue throughout the&#xD;
      disease trajectory. However, little is known about how to provide both patients and families&#xD;
      with access to timely information about patient health and mechanisms to communicate directly&#xD;
      with health care providers, as proposed in this study.&#xD;
&#xD;
      The goal of this study is to test a multicomponent intervention to strengthen communication&#xD;
      and longitudinal partnerships among women with breast cancer and their family members. Recent&#xD;
      work by the study team has demonstrated the feasibility, acceptability, and benefit of&#xD;
      intervention components which will be combined into a single model of care. The study team's&#xD;
      preliminary studies indicate that clarifying patient and family expectations regarding the&#xD;
      role of family and providing family with timely and comprehensive information about patient&#xD;
      health (as desired by the patient) leads to more effective family involvement, more frequent&#xD;
      patient-family-provider interactions, more patient-centered communication, and greater&#xD;
      preparedness to manage care.&#xD;
&#xD;
      This study will evaluate the feasibility of delivering a multicomponent communication&#xD;
      intervention in the outpatient setting comprising: 1.) a patient-family agenda-setting&#xD;
      checklist completed immediately before a regularly scheduled medical oncology visit with a&#xD;
      participating medical oncologist, 2.) facilitated registration for the patient portal (for&#xD;
      patient and family member, as desired by the patient), and 3.) education (as relevant) on&#xD;
      access to doctor's electronic visit notes. The study will focus on patients who typically&#xD;
      attend medical oncology visits with a family member or trusted friend who are already present&#xD;
      and involved in communication. This study will enroll up to 132 patients who are on active&#xD;
      treatment for breast cancer, up to 132 family member/friend &quot;companions&quot; and up to 14 medical&#xD;
      oncology providers. The study team will compare patients and companions who are in the&#xD;
      intervention group (n=60 dyads) with patients and companions who are in the control group and&#xD;
      receive usual medical oncology care (n=60 dyads). This study will compare quality of&#xD;
      communication with medical oncology providers, understanding of patient's cancer, confidence&#xD;
      in managing patient's care, satisfaction with cancer care, and symptoms of anxiety after 3&#xD;
      months, 9 months, and 12 months of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">November 7, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Between-group Differences in Patient Complete Illness Understanding at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Between-group Differences in Patient Anxiety at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Between-group Differences in Care Partner Complete Illness Understanding at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Between-group Differences in Care Partner Anxiety at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Between-group Differences in Patient Quality of Communication at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between-group Differences in Care Partner Quality of Communication at 9-months</measure>
    <time_frame>9 months</time_frame>
    <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Active Breast Cancer Treatment</condition>
  <arm_group>
    <arm_group_label>Multicomponent Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Care as usual with the medical oncologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Checklist, MyChart, OpenNotes</intervention_name>
    <description>1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.</description>
    <arm_group_label>Multicomponent Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Routine medical oncology care</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medical oncology patient: Established patient of participating medical oncologist&#xD;
             greater than 18 years of age, have a diagnosis of early stage or advanced breast&#xD;
             cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic&#xD;
             therapy if early stage), are English speaking, able to provide informed consent&#xD;
             themselves, and identify a family member who they would like to include in their care.&#xD;
&#xD;
          2. Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other&#xD;
             relative) or unpaid friend who regularly accompanies patient to medical oncology&#xD;
             visits.&#xD;
&#xD;
          3. Medical oncology provider: Practicing medical oncology provider at a participating&#xD;
             clinic who provides care to patients with breast cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical oncology patients: Younger than 18 years, pregnant, not being treated for&#xD;
             breast cancer, do not attend medical oncology visits with family member or unpaid&#xD;
             friend or unwilling for their family member or unpaid friend to be contacted.&#xD;
&#xD;
          2. Care partner: Paid non-family member who accompanies patient to visits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Wolff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Kimmel Cancer Center - Medical Oncology</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Kimmel Cancer Center at Green Spring Station - Medical Oncology</name>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.</citation>
    <PMID>24417565</PMID>
  </reference>
  <reference>
    <citation>Wolff JL, Berger A, Clarke D, Green JA, Stametz R, Yule C, Darer JD. Patients, care partners, and shared access to the patient portal: online practices at an integrated health system. J Am Med Inform Assoc. 2016 Nov;23(6):1150-1158. doi: 10.1093/jamia/ocw025. Epub 2016 Mar 28.</citation>
    <PMID>27026614</PMID>
  </reference>
  <reference>
    <citation>Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012 Oct 2;157(7):461-70. doi: 10.7326/0003-4819-157-7-201210020-00002. Erratum In: Ann Intern Med. 2015 Apr 7;162(7):532.</citation>
    <PMID>23027317</PMID>
  </reference>
  <results_reference>
    <citation>Wolff JL, Aufill J, Echavarria D, Heughan JA, Lee KT, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Thorner E, Zafman N, Levy HP, Dy SM, Wolff AC. Sharing in care: engaging care partners in the care and communication of breast cancer patients. Breast Cancer Res Treat. 2019 Aug;177(1):127-136. doi: 10.1007/s10549-019-05306-9. Epub 2019 Jun 4.</citation>
    <PMID>31165374</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>February 23, 2021</results_first_submitted>
  <results_first_submitted_qc>February 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2021</results_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This research involves the collection of data and identifying information from approximately 278 diverse study participants including up to 14 medical oncology clinicians, 132 breast cancer patients, and 132 family member or friend companions. The final dataset will include self-reported demographic and health status measures, information from electronic health records, and information about participant experiences. Even though the final dataset will be stripped of identifying information prior to analysis, the study team believes that there remains a possibility of deductive disclosure of subjects. Upon written request from members of the research community, the following resources will be shared: documentation of the process for accessing the study data and constructing the analytic dataset; the codebook for the master analytic dataset; the analytic plan for each study aim; the algorithms used for measurement of outcome variables; surveys and questionnaires.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03283553/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients of participating clinicians who were in active treatment for early stage or advanced breast cancer were mailed letters describing the study 3 weeks before their next scheduled visit. Patients who did not &quot;opt out&quot; by mail were contacted by research staff to discuss study procedures and administer a screening interview.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Multicomponent Intervention</title>
          <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Care as usual with the medical oncologist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Patient Participant Flow</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patient Baseline Interview</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patient 3-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patient 9-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patient 12-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Care Partner Participant Flow</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Care Partner Baseline Interview</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Care Partner 3-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Care Partner 9-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Care Partner 12-Month Interview</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued because patient death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Overall Number of Baseline Participants include 69 dyads (one patient, one care partner) in the intervention arm and 63 dyads (one patient, one care partner) in the usual care arm, for a total of 132 dyads in the study. Baseline participant data for patient and care partner is reported here distinctly, where possible.</population>
      <group_list>
        <group group_id="B1">
          <title>Multicomponent Intervention</title>
          <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Care as usual with the medical oncologist.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="132"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Patient age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.1" spread="13.4"/>
                    <measurement group_id="B2" value="52.9" spread="14.5"/>
                    <measurement group_id="B3" value="54.1" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Care Partner age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.0" spread="13.79"/>
                    <measurement group_id="B2" value="54.0" spread="13.5"/>
                    <measurement group_id="B3" value="54" spread="13.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Patient sex</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Care Partner sex</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Patient Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Care Partner Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Patient Race</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Care Partner Race</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Breast Cancer Disease Stage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Early Stage Breast Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Metastatic Breast Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Patient Complete Illness Understanding at 9-months</title>
        <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Patient Complete Illness Understanding at 9-months</title>
          <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Illness Understanding at 9-Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Complete Illness Understanding at 9-Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.264</p_value>
            <p_value_desc>P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months</title>
        <description>Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months</title>
          <description>Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="3.9"/>
                    <measurement group_id="O2" value="15.4" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.555</p_value>
            <p_value_desc>P-value represents the significance of the term for group assignment.</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Patient Anxiety at 9-months</title>
        <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Patient Anxiety at 9-months</title>
          <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Symptoms of Anxiety at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Symptoms of Anxiety at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.619</p_value>
            <p_value_desc>P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Care Partner Complete Illness Understanding at 9-months</title>
        <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Complete Illness Understanding at 9-months</title>
          <description>Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Illness Understanding at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Complete Illness Understanding at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.532</p_value>
            <p_value_desc>P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months</title>
        <description>Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months</title>
          <description>Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include &quot;very satisfied&quot; (2 points), &quot;satisfied&quot; (1 point), or &quot;not satisfied&quot; (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" spread="4.4"/>
                    <measurement group_id="O2" value="15.4" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.108</p_value>
            <p_value_desc>P-value represents the significance of the term for group assignment.</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Between-group Differences in Care Partner Anxiety at 9-months</title>
        <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Anxiety at 9-months</title>
          <description>Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Symptoms of Anxiety at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Symptoms of Anxiety at 9-Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.405</p_value>
            <p_value_desc>P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Between-group Differences in Patient Quality of Communication at 9-months</title>
        <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Patient Quality of Communication at 9-months</title>
          <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.8" spread="11.6"/>
                    <measurement group_id="O2" value="88.0" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.412</p_value>
            <p_value_desc>P-value represents the significance of the term for group assignment.</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Between-group Differences in Care Partner Quality of Communication at 9-months</title>
        <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Quality of Communication at 9-months</title>
          <description>Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3" spread="10.3"/>
                    <measurement group_id="O2" value="86.2" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.872</p_value>
            <p_value_desc>P-value represents the significance of the term for group assignment.</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusts for baseline patient education, care partner gender, and patient disease stage.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Between-group Differences in Care Partner Registration for Shared Access to the Patient Portal at 9-months</title>
        <description>Care partner registration for shared access to the patient portal was assessed at baseline and nine-months post-enrollment.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Registration for Shared Access to the Patient Portal at 9-months</title>
          <description>Care partner registration for shared access to the patient portal was assessed at baseline and nine-months post-enrollment.</description>
          <population>The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Care Partner Registered by 9 Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Care Partner Did Not Register by 9 Months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
            <method_desc>P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Between-group Differences in Patient Views of Clinical Visit Notes in the Patient Portal at 9-months</title>
        <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions.Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the patients who used a patient portal feature at least once during 9 month follow up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Patient Views of Clinical Visit Notes in the Patient Portal at 9-months</title>
          <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions.Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
          <population>The analysis sample includes the patients who used a patient portal feature at least once during 9 month follow up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Patient Viewed a Clinical Visit Note by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient Did Not View a Clinical Visit Note by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Fisher Exact</method>
            <method_desc>P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Between-group Differences in Care Partner Views of Clinical Visit Notes in the Patient Portal at 9-months</title>
        <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Views of Clinical Visit Notes in the Patient Portal at 9-months</title>
          <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
          <population>The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Care Partner Viewed a Clinical Visit Note by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Care Partner Did Not View a Clinical Visit Note by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
            <method_desc>P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Between-group Differences in Patient Exchange of Direct Messages in the Patient Portal at 9-months</title>
        <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the patients who logged in to the patient portal at least once during 9 month follow up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.&#xD;
Checklist, MyChart, OpenNotes: 1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.&#xD;
Usual Care: Routine medical oncology care</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Patient Exchange of Direct Messages in the Patient Portal at 9-months</title>
          <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
          <population>The analysis sample includes the patients who logged in to the patient portal at least once during 9 month follow up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Patient Exchanged a Direct Message by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient Did Not Exchange a Direct Message by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.128</p_value>
            <p_value_desc>P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Between-group Differences in Care Partner Exchange of Direct Messages in the Patient Portal at 9-months</title>
        <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
        <time_frame>9 months</time_frame>
        <population>The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Multicomponent Intervention</title>
            <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with the medical oncologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Between-group Differences in Care Partner Exchange of Direct Messages in the Patient Portal at 9-months</title>
          <description>Patient portal use was assessed from date and time-stamped interactions reflecting the frequency, timing, and type of patient portal interactions. Use of the patient portal refers to interactions between enrollment and up to 40-weeks post-enrollment.</description>
          <population>The analysis sample includes the care partners who logged in to the patient portal at least once during 9 month follow up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Care Partner Exchanged a Direct Message by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Care Partner Did Not Exchange a Direct Message by 9-months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.247</p_value>
            <p_value_desc>P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Assessed for patients only.</desc>
      <group_list>
        <group group_id="E1">
          <title>Multicomponent Intervention</title>
          <description>1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Care as usual with the medical oncologist.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research Program Manager</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-614-7910</phone>
      <email>dechava1@jhu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03283553
org study id: J1735
secondary id: IRB00129995
secondary id: SAC170001
nct id: NCT03283553
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates a multi-component communication intervention in the outpatient setting
      to strengthen communication among patients being actively treated for breast cancer and their
      support network of family members and friends. The intervention comprises: 1.) a
      patient-family agenda-setting checklist completed immediately before a regularly scheduled
      oncology visit, 2.) facilitated registration for the patient portal (for patient and family
      member, as desired by the patient), and 3.) education (as relevant) on access to clinician
      electronic visit notes. The study team will conduct a two-group randomized trial to examine
      feasibility of the protocol and to compare quality of communication with oncology providers,
      understanding of patient's cancer, confidence in managing patient's care and satisfaction
      with cancer care between patient-companion dyads who are in the intervention group (n=60) and
      patient-companion dyads who receive usual medical oncology care (n=60).
Breast cancer is the most common cancer among survivors in the US. Most patients with breast
      cancer receive help from family in making complex decisions about treatment, handling
      logistically demanding care coordination, and managing symptoms and side effects. Although
      family members (as defined by each patient) play a vital role in cancer care, they are not
      formally recognized or assessed in care delivery, and their need for information and support
      is typically unmet. Lack of attention to family in care delivery is an important gap that too
      often leaves families without adequate information about patient health and treatments. This
      may prevent families and patients from engaging in open conversations, cause them unnecessary
      anxiety, and negatively affect the quality of cancer care and delivery.

      Communication is particularly important in cancer care, as the optimal course of action is
      determined through longitudinal discussion of prognosis, treatments, and patient goals,
      preferences, and concerns. Strategies to improve communication for serious illnesses such as
      cancer have been developed, but typically target a specific decision, conversation, or
      setting, most often the inpatient hospital. There is growing agreement that communication
      among patients, families, and providers should be initiated early and continue throughout the
      disease trajectory. However, little is known about how to provide both patients and families
      with access to timely information about patient health and mechanisms to communicate directly
      with health care providers, as proposed in this study.

      The goal of this study is to test a multicomponent intervention to strengthen communication
      and longitudinal partnerships among women with breast cancer and their family members. Recent
      work by the study team has demonstrated the feasibility, acceptability, and benefit of
      intervention components which will be combined into a single model of care. The study team's
      preliminary studies indicate that clarifying patient and family expectations regarding the
      role of family and providing family with timely and comprehensive information about patient
      health (as desired by the patient) leads to more effective family involvement, more frequent
      patient-family-provider interactions, more patient-centered communication, and greater
      preparedness to manage care.

      This study will evaluate the feasibility of delivering a multicomponent communication
      intervention in the outpatient setting comprising: 1.) a patient-family agenda-setting
      checklist completed immediately before a regularly scheduled medical oncology visit with a
      participating medical oncologist, 2.) facilitated registration for the patient portal (for
      patient and family member, as desired by the patient), and 3.) education (as relevant) on
      access to doctor's electronic visit notes. The study will focus on patients who typically
      attend medical oncology visits with a family member or trusted friend who are already present
      and involved in communication. This study will enroll up to 132 patients who are on active
      treatment for breast cancer, up to 132 family member/friend "companions" and up to 14 medical
      oncology providers. The study team will compare patients and companions who are in the
      intervention group (n=60 dyads) with patients and companions who are in the control group and
      receive usual medical oncology care (n=60 dyads). This study will compare quality of
      communication with medical oncology providers, understanding of patient's cancer, confidence
      in managing patient's care, satisfaction with cancer care, and symptoms of anxiety after 3
      months, 9 months, and 12 months of follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Care Provider, Investigator)
measure: Between-group Differences in Patient Complete Illness Understanding at 9-months
time frame: 9 months
description: Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
measure: Between-group Differences in Mean Patient Satisfaction With Cancer Care at 9-months
time frame: 9 months
description: Outcome was measured with the short-form 10-item version of the Family Satisfaction with Cancer Care (FAMCARE) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
measure: Between-group Differences in Patient Anxiety at 9-months
time frame: 9 months
description: Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
measure: Between-group Differences in Care Partner Complete Illness Understanding at 9-months
time frame: 9 months
description: Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.
measure: Between-group Differences in Care Partner Satisfaction With Cancer Care at 9-months
time frame: 9 months
description: Outcome was measured with the short-form 10-item version of the FAMCARE (Family Satisfaction with Cancer Care) questionnaire, a validated multi-item instrument that was developed to assess family perspective on cancer care. Respondents are asked to rate 10 items that relate to emotional support, personalization of care, support of decision-making, accessibility, and coordination. Response categories include "very satisfied" (2 points), "satisfied" (1 point), or "not satisfied" (0 points), and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores reflecting greater satisfaction.
measure: Between-group Differences in Care Partner Anxiety at 9-months
time frame: 9 months
description: Outcome was measured using the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), a well-established 2-item instrument that asks about symptoms of anxiety in a two-week recall period from 0 ("not at all") to 3 ("nearly every day"). Full range is 0-6 with higher scores indicating more anxiety. Symptoms of anxiety refer to a cutpoint of 3+ on the GAD-2.
measure: Between-group Differences in Patient Quality of Communication at 9-months
time frame: 9 months
description: Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
measure: Between-group Differences in Care Partner Quality of Communication at 9-months
time frame: 9 months
description: Outcome was measured using the Quality of Communication (QC) Scale, a validated 10-item instrument to assess quality of communication between the participant and the medical oncology team. The scale for each item is from 0 ('Worst you can imagine') to 10 ('Best you can imagine'). Full range is 0-100 with higher scores indicating higher perceived quality of communication.
arm group label: Multicomponent Intervention
arm group type: Experimental
description: 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.
arm group label: Usual Care
arm group type: Placebo Comparator
description: Care as usual with the medical oncologist.
intervention type: Other
intervention name: Checklist, MyChart, OpenNotes
description: 1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.
arm group label: Multicomponent Intervention
intervention type: Other
intervention name: Usual Care
description: Routine medical oncology care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Wolff, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
citation: Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.
PMID: 24417565
citation: Wolff JL, Berger A, Clarke D, Green JA, Stametz R, Yule C, Darer JD. Patients, care partners, and shared access to the patient portal: online practices at an integrated health system. J Am Med Inform Assoc. 2016 Nov;23(6):1150-1158. doi: 10.1093/jamia/ocw025. Epub 2016 Mar 28.
PMID: 27026614
citation: Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012 Oct 2;157(7):461-70. doi: 10.7326/0003-4819-157-7-201210020-00002. Erratum In: Ann Intern Med. 2015 Apr 7;162(7):532.
PMID: 23027317
citation: Wolff JL, Aufill J, Echavarria D, Heughan JA, Lee KT, Connolly RM, Fetting JH, Jelovac D, Papathakis K, Riley C, Stearns V, Thorner E, Zafman N, Levy HP, Dy SM, Wolff AC. Sharing in care: engaging care partners in the care and communication of breast cancer patients. Breast Cancer Res Treat. 2019 Aug;177(1):127-136. doi: 10.1007/s10549-019-05306-9. Epub 2019 Jun 4.
PMID: 31165374
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
ipd description: This research involves the collection of data and identifying information from approximately 278 diverse study participants including up to 14 medical oncology clinicians, 132 breast cancer patients, and 132 family member or friend companions. The final dataset will include self-reported demographic and health status measures, information from electronic health records, and information about participant experiences. Even though the final dataset will be stripped of identifying information prior to analysis, the study team believes that there remains a possibility of deductive disclosure of subjects. Upon written request from members of the research community, the following resources will be shared: documentation of the process for accessing the study data and constructing the analytic dataset; the codebook for the master analytic dataset; the analytic plan for each study aim; the algorithms used for measurement of outcome variables; surveys and questionnaires.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 