<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/NCT03786458</url>
  </required_header>
  <id_info>
    <org_study_id>201810014RIND</org_study_id>
    <nct_id>NCT03786458</nct_id>
  </id_info>
  <brief_title>Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients</brief_title>
  <official_title>Development and Evaluation of Web-Based Fertility-Related Decision Support for Young Female Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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 aims to develop a patient-centered, user-center, interactive web-based decision&#xD;
      aid to support the young women with cancer in making an informed fertility-related decision&#xD;
      and further evaluate its efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses mixed-method and involves 2 stages. As following the IPDAS recommendation for&#xD;
      developing decision aids, the first sample of 25 young woman survivors with breast,&#xD;
      hematology or ovarian cancer, and oncologist, fertility specialists or nurses will be&#xD;
      interviewed to assess the fertility-related decision needs from and. The decision aid is then&#xD;
      developed further process of evidence synthesis and multidisciplinary external review. After&#xD;
      the draft being evaluated for its validity via Think-aloud cognitive interview method, field&#xD;
      testing via one-group quasi-experimental design on 90 young women with newly diagnosed&#xD;
      breast, hematology or ovarian cancer will be applied to test its outcomes of decision&#xD;
      quality, emotional health and fertility concerns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Anticipated">November 27, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Decisional scale</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Infertility, Female</condition>
  <condition>Female Infertility</condition>
  <arm_group>
    <arm_group_label>Cancer and Fertility Decision making</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cancer and Fertility Decision aid</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>web-based decision aid</intervention_name>
    <description>The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.</description>
    <arm_group_label>Cancer and Fertility Decision making</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20 to 44&#xD;
&#xD;
          -  Have been diagnosed with breast, hematology or ovarian cancer, and will conduct cancer&#xD;
             treatment, such as chemotherapy, hormonal or radiation.&#xD;
&#xD;
          -  Willing to take questionnaire via computer and tablet.&#xD;
&#xD;
          -  Ability to answer the questionnaire with functional emotion and cognition.&#xD;
&#xD;
          -  Ability to read newspaper.&#xD;
&#xD;
          -  Had been consulted and advised by Doctor on the ability of fertility, but have not&#xD;
             decided to give birth to a baby.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 20 or above 45.&#xD;
&#xD;
          -  Had been diagnosed with stage 4 cancer.&#xD;
&#xD;
          -  Do not require chemotherapy, hormonal or radiation therapy.&#xD;
&#xD;
          -  Not able to read newspaper or do not access the internet.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Fang Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiu-Yu K Lee, PhD</last_name>
    <phone>886-2-2822-7101</phone>
    <phone_ext>3316</phone_ext>
    <email>shiuyu@ntunhs.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei City</city>
        <state>Taipei</state>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen-Fang Cheng</last_name>
      <email>wenfangcheng@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>young female cancer patients</keyword>
  <keyword>decision aids</keyword>
  <keyword>fertility concerns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</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/NCT03786458
org study id: 201810014RIND
nct id: NCT03786458
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to develop a patient-centered, user-center, interactive web-based decision
      aid to support the young women with cancer in making an informed fertility-related decision
      and further evaluate its efficacy.
This study uses mixed-method and involves 2 stages. As following the IPDAS recommendation for
      developing decision aids, the first sample of 25 young woman survivors with breast,
      hematology or ovarian cancer, and oncologist, fertility specialists or nurses will be
      interviewed to assess the fertility-related decision needs from and. The decision aid is then
      developed further process of evidence synthesis and multidisciplinary external review. After
      the draft being evaluated for its validity via Think-aloud cognitive interview method, field
      testing via one-group quasi-experimental design on 90 young women with newly diagnosed
      breast, hematology or ovarian cancer will be applied to test its outcomes of decision
      quality, emotional health and fertility concerns.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Decision conflict,decision regret,fertility knowledge,reproductive concerns after cancer,quality of life
time frame: 6 months
description: Decisional scale
arm group label: Cancer and Fertility Decision making
arm group type: Experimental
description: Cancer and Fertility Decision aid
intervention type: Behavioral
intervention name: web-based decision aid
description: The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.
arm group label: Cancer and Fertility Decision making
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: No
last name: Wen-Fang Cheng
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Shiu-Yu K Lee, PhD
phone: 886-2-2822-7101
phone ext: 3316
email: shiuyu@ntunhs.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female