<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/NCT02259699</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI CE-12-11-4755</org_study_id>
    <nct_id>NCT02259699</nct_id>
  </id_info>
  <brief_title>Ovarian Cancer Patient-Centered Decision Aid</brief_title>
  <acronym>PCOA</acronym>
  <official_title>Ovarian Cancer Patient-Centered Decision Aid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to develop and test a new decision aid -named Patient Centered&#xD;
      Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs&#xD;
      about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on&#xD;
      their own preferences and personal clinical characteristics, described in terms that are&#xD;
      meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient-&#xD;
      and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized&#xD;
      controlled trial (RCT).&#xD;
&#xD;
      The investigators hypothesize that PCOA will be significantly better than usual care,&#xD;
      resulting in patients reporting more satisfaction with their treatment decision, less&#xD;
      decision regret, better quality of life, and more satisfaction with their care compared with&#xD;
      similar patients not having access to PCOA. If these hypotheses are substantiated, patients&#xD;
      and providers will have an improved model for communication and decision making, leading to&#xD;
      better patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer is typically diagnosed at an advanced stage and carries the highest&#xD;
      fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States.&#xD;
      Arguably the most effective treatment regimen to date is provided through intraperitoneal&#xD;
      (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most&#xD;
      recent phase III randomized trial conferred the longest median survival (65.6 months) ever&#xD;
      reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm.&#xD;
      However, during active treatment, patients randomized to the IP therapy group reported&#xD;
      significantly worse quality of life (QOL), and more treatment-related toxicities. In short,&#xD;
      women are less likely to die if they receive an IP component to their chemotherapy, a finding&#xD;
      that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP&#xD;
      treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for&#xD;
      patients to understand and then incorporate meaningfully into their decision-making process.&#xD;
      In fact, for reasons that are not entirely clear, many patients are not offered IP therapy.&#xD;
      Patient-centered care requires that they be given the opportunity to participate in treatment&#xD;
      decision-making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction With Decision</measure>
    <time_frame>at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)</time_frame>
    <description>Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decisional Regret</measure>
    <time_frame>At treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
    <description>The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask &quot;about the decision you made about selecting IP/IV treatment.&quot; Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shared Decision Making</measure>
    <time_frame>at treatment initiation (T1)</time_frame>
    <description>The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., &quot;My doctor and I selected a treatment option together&quot;). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Care (EORTC) Overall Quality Rating</measure>
    <time_frame>at treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
    <description>Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Therapy Satisfaction</measure>
    <time_frame>at treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
    <description>While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.&#xD;
This has been validated on adults with many cancer types and treatments.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Process Outcome - Satisfaction With PCOA Aid</measure>
    <time_frame>at treatment initiation</time_frame>
    <description>Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Stage III Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Decision Aid (PCOA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UC (Standard care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
    <arm_group_label>Decision Aid (PCOA)</arm_group_label>
    <other_name>Patient Centered Outcome Aid (PCOA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  RCT participants will include stage III optimally debulked advanced ovarian cancer&#xD;
             patients from urban and rural regions of the country, who will be randomized to either&#xD;
             our patient-centered decision-aid or the usual care control arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  By the nature of the neoplasm under study, gender specific (ovarian cancer), only&#xD;
             female patients will be included&#xD;
&#xD;
          -  Patient enrollment will include women from all English speaking ethnic groups&#xD;
&#xD;
             -&gt; the age of 21&#xD;
&#xD;
          -  All minority ovarian cancer survivors will be eligible&#xD;
&#xD;
          -  Women under age 21 will not be included in this study because it is not common to be&#xD;
             diagnosed with advanced epithelial ovarian cancer in females under age 21&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lari Wenzel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>May 15, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <results_first_submitted>February 21, 2017</results_first_submitted>
  <results_first_submitted_qc>March 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2019</results_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Lari Wenzel</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Intraperitoneal chemotherapy</keyword>
  <keyword>Intravenous chemotherapy</keyword>
  <keyword>decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Decision Aid (PCOA)</title>
          <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
        </group>
        <group group_id="P2">
          <title>UC (Standard Care)</title>
          <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Decision Aid (PCOA)</title>
          <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
        </group>
        <group group_id="B2">
          <title>UC (Standard Care)</title>
          <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</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="64"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="124"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.1" spread="11.0"/>
                    <measurement group_id="B2" value="58.2" spread="8.8"/>
                    <measurement group_id="B3" value="58.1" spread="10.0"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</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>Male</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_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="64"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction With Decision</title>
        <description>Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.</description>
        <time_frame>at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)</time_frame>
        <population>Includes 63 PCOA and 56 UC with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
          <group group_id="O2">
            <title>UC (Standard Care)</title>
            <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Decision</title>
          <description>Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.</description>
          <population>Includes 63 PCOA and 56 UC with complete data</population>
          <units>transformed scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.3" spread="2.0"/>
                    <measurement group_id="O2" value="86.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.8" spread="2.1"/>
                    <measurement group_id="O2" value="91.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.1" spread="2.4"/>
                    <measurement group_id="O2" value="90.6" spread="2.3"/>
                  </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>Difference between arms at T1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.582</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between arms at T3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.053</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between arms at T4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.288</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Decisional Regret</title>
        <description>The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask &quot;about the decision you made about selecting IP/IV treatment.&quot; Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.</description>
        <time_frame>At treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
        <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
          <group group_id="O2">
            <title>UC (Standard Care)</title>
            <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Regret</title>
          <description>The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask &quot;about the decision you made about selecting IP/IV treatment.&quot; Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.</description>
          <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
          <units>transformed scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="2.0"/>
                    <measurement group_id="O2" value="11.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" spread="2.6"/>
                    <measurement group_id="O2" value="15.0" spread="2.5"/>
                  </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>Difference between arms at T3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.087</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between arms at T4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.910</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shared Decision Making</title>
        <description>The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., &quot;My doctor and I selected a treatment option together&quot;). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made.</description>
        <time_frame>at treatment initiation (T1)</time_frame>
        <population>Includes 63 PCOA and 56 UC with complete data</population>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
          <group group_id="O2">
            <title>UC (Standard Care)</title>
            <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
          </group>
        </group_list>
        <measure>
          <title>Shared Decision Making</title>
          <description>The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., &quot;My doctor and I selected a treatment option together&quot;). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made.</description>
          <population>Includes 63 PCOA and 56 UC with complete data</population>
          <units>tansformed scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5" spread="2.2"/>
                    <measurement group_id="O2" value="78.7" spread="2.6"/>
                  </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>0.807</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Care (EORTC) Overall Quality Rating</title>
        <description>Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.</description>
        <time_frame>at treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
        <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
          <group group_id="O2">
            <title>UC (Standard Care)</title>
            <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Care (EORTC) Overall Quality Rating</title>
          <description>Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.</description>
          <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
          <units>tansformed scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" spread="3.0"/>
                    <measurement group_id="O2" value="90.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" spread="3.5"/>
                    <measurement group_id="O2" value="86.9" spread="3.0"/>
                  </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>Difference between arms at T3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.071</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between arms at T4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.332</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Therapy Satisfaction</title>
        <description>While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.&#xD;
This has been validated on adults with many cancer types and treatments.</description>
        <time_frame>at treatment completion (T3) and 9 months post enrollment (T4)</time_frame>
        <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
          <group group_id="O2">
            <title>UC (Standard Care)</title>
            <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Therapy Satisfaction</title>
          <description>While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.&#xD;
This has been validated on adults with many cancer types and treatments.</description>
          <population>Includes 48 PCOA and 52 UC with complete data at T3</population>
          <units>tansformed scale score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.9" spread="1.9"/>
                    <measurement group_id="O2" value="85.8" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.0" spread="2.4"/>
                    <measurement group_id="O2" value="81.9" spread="3.0"/>
                  </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>Difference between arms at T3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.177</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between arms at T4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.745</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Process Outcome - Satisfaction With PCOA Aid</title>
        <description>Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.</description>
        <time_frame>at treatment initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Decision Aid (PCOA)</title>
            <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
          </group>
        </group_list>
        <measure>
          <title>Process Outcome - Satisfaction With PCOA Aid</title>
          <description>Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Quite a bit satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little bit satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not at all satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Decision Aid (PCOA)</title>
          <description>Decision Aid: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.</description>
        </group>
        <group group_id="E2">
          <title>UC (Standard Care)</title>
          <description>Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Dr. Lari Wenzel</name_or_title>
      <organization>University of California, Irvine</organization>
      <phone>949-824-3926</phone>
      <email>lwenzel@uci.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/NCT02259699
org study id: PCORI CE-12-11-4755
nct id: NCT02259699
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to develop and test a new decision aid -named Patient Centered
      Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs
      about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on
      their own preferences and personal clinical characteristics, described in terms that are
      meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient-
      and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized
      controlled trial (RCT).

      The investigators hypothesize that PCOA will be significantly better than usual care,
      resulting in patients reporting more satisfaction with their treatment decision, less
      decision regret, better quality of life, and more satisfaction with their care compared with
      similar patients not having access to PCOA. If these hypotheses are substantiated, patients
      and providers will have an improved model for communication and decision making, leading to
      better patient outcomes.
Ovarian cancer is typically diagnosed at an advanced stage and carries the highest
      fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States.
      Arguably the most effective treatment regimen to date is provided through intraperitoneal
      (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most
      recent phase III randomized trial conferred the longest median survival (65.6 months) ever
      reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm.
      However, during active treatment, patients randomized to the IP therapy group reported
      significantly worse quality of life (QOL), and more treatment-related toxicities. In short,
      women are less likely to die if they receive an IP component to their chemotherapy, a finding
      that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP
      treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for
      patients to understand and then incorporate meaningfully into their decision-making process.
      In fact, for reasons that are not entirely clear, many patients are not offered IP therapy.
      Patient-centered care requires that they be given the opportunity to participate in treatment
      decision-making.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Satisfaction With Decision
time frame: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
description: Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.
measure: Decisional Regret
time frame: At treatment completion (T3) and 9 months post enrollment (T4)
description: The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask "about the decision you made about selecting IP/IV treatment." Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.
measure: Shared Decision Making
time frame: at treatment initiation (T1)
description: The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., "My doctor and I selected a treatment option together"). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made.
measure: Satisfaction With Care (EORTC) Overall Quality Rating
time frame: at treatment completion (T3) and 9 months post enrollment (T4)
description: Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.
measure: Cancer Therapy Satisfaction
time frame: at treatment completion (T3) and 9 months post enrollment (T4)
description: While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.
This has been validated on adults with many cancer types and treatments.
measure: Process Outcome - Satisfaction With PCOA Aid
time frame: at treatment initiation
description: Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.
arm group label: Decision Aid (PCOA)
arm group type: Experimental
description: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
arm group label: UC (Standard care)
arm group type: No Intervention
description: Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
intervention type: Other
intervention name: Decision Aid
description: PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
arm group label: Decision Aid (PCOA)
other name: Patient Centered Outcome Aid (PCOA)
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lari Wenzel, PhD
role: Principal Investigator
affiliation: University of California, Irvine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Lari Wenzel
investigator title: Professor of Medicine
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 