<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/NCT03004391</url>
  </required_header>
  <id_info>
    <org_study_id>CA125-DA</org_study_id>
    <nct_id>NCT03004391</nct_id>
  </id_info>
  <brief_title>Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125</brief_title>
  <official_title>Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Design School Kolding</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vejle Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU)&#xD;
      program for ovarian cancer patients. The new FU program argues that there is no effect of&#xD;
      routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish&#xD;
      routine measurement of CA 125 to be part of the follow-up program.&#xD;
&#xD;
      Shared Decision Making (SDM) can help health professionals develop a more individualized care&#xD;
      plan in collaboration with the patient, as stated in the revised national FU program. Due to&#xD;
      the complexity and challenges within ovarian cancer care, this is an evident area of focus.&#xD;
&#xD;
      SDM is defined as an approach in which the clinician and patient go through all phases of the&#xD;
      decision-making process together and share the preference for treatment and reach an&#xD;
      agreement on treatment choice. Clinicians have information about disease, tests and&#xD;
      treatments, whereas patients hold information about their life circumstances, goals of life,&#xD;
      and preferences for healthcare. SDM thereby offers a way of individualizing recommendations,&#xD;
      according to patients' special needs and preferences. SDM has potential to give the patients&#xD;
      a higher quality of healthcare by putting the patient in the center of care.&#xD;
&#xD;
      Decision aids (DA) are tools that can provide information and systematically describe the&#xD;
      advantages and disadvantages of a specific intervention or monitoring, which can help&#xD;
      patients become involved in decision making. Using evidence-based DA leads to improvement in&#xD;
      knowledge, better understanding of screening, prevention and treatment options, and more&#xD;
      accurate perception of risks for the patients.&#xD;
&#xD;
      All participants fill in a demographic and Decisional Conflict Scale questionnaire at&#xD;
      baseline. After having been presented with the decision aid and made a choice as to CA125,&#xD;
      the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire&#xD;
      dealing with confidence as to the choice made and the level of shared decision making&#xD;
      experienced. Six months later the Decision Regret Scale questionnaire is to be completed to&#xD;
      reveal any regrets in relation to the CA125 decision.&#xD;
&#xD;
      For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible&#xD;
      for this study will be asked for their opinion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient uncertainty as to routine measurement of CA125 is measured by combined questionnaires CollaboRATE and Decisional Conflict Scale.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction as to choice made measured by questionnaire Decision Regret Scale</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Ovarian Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient diagnosed with ovarian cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;18 years of age&#xD;
&#xD;
          -  Histologically confirmed epithelial ovarian, fallopian tube or serous primary&#xD;
             peritoneal cancer&#xD;
&#xD;
          -  Have completed their first line treatment, with complete remission.&#xD;
&#xD;
          -  Manage to read and speak Danish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have recurrent disease after first line treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anette S. Kargo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark and Vejle Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karina D. Steffensen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southern Denmark and Vejle Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shared decision making</keyword>
  <keyword>Follow-up</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004391
org study id: CA125-DA
nct id: NCT03004391
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In 2015 the Danish Health authorities initiated major changes in the national follow-up (FU)
      program for ovarian cancer patients. The new FU program argues that there is no effect of
      routine monitoring of tumour marker CA125. Now every patient needs to choose if they wish
      routine measurement of CA 125 to be part of the follow-up program.

      Shared Decision Making (SDM) can help health professionals develop a more individualized care
      plan in collaboration with the patient, as stated in the revised national FU program. Due to
      the complexity and challenges within ovarian cancer care, this is an evident area of focus.

      SDM is defined as an approach in which the clinician and patient go through all phases of the
      decision-making process together and share the preference for treatment and reach an
      agreement on treatment choice. Clinicians have information about disease, tests and
      treatments, whereas patients hold information about their life circumstances, goals of life,
      and preferences for healthcare. SDM thereby offers a way of individualizing recommendations,
      according to patients' special needs and preferences. SDM has potential to give the patients
      a higher quality of healthcare by putting the patient in the center of care.

      Decision aids (DA) are tools that can provide information and systematically describe the
      advantages and disadvantages of a specific intervention or monitoring, which can help
      patients become involved in decision making. Using evidence-based DA leads to improvement in
      knowledge, better understanding of screening, prevention and treatment options, and more
      accurate perception of risks for the patients.

      All participants fill in a demographic and Decisional Conflict Scale questionnaire at
      baseline. After having been presented with the decision aid and made a choice as to CA125,
      the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire
      dealing with confidence as to the choice made and the level of shared decision making
      experienced. Six months later the Decision Regret Scale questionnaire is to be completed to
      reveal any regrets in relation to the CA125 decision.

      For a preliminary investigation of the applicability of the DA, 15-20 patients not eligible
      for this study will be asked for their opinion.
observational model: Case-Only
time perspective: Prospective
measure: Patient uncertainty as to routine measurement of CA125 is measured by combined questionnaires CollaboRATE and Decisional Conflict Scale.
time frame: 6 months
measure: Patient satisfaction as to choice made measured by questionnaire Decision Regret Scale
time frame: 6 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anette S. Kargo, MD
role: Principal Investigator
affiliation: University of Southern Denmark and Vejle Hospital, Denmark
last name: Karina D. Steffensen, MD, PhD
role: Study Director
affiliation: University of Southern Denmark and Vejle Hospital, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial