<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/NCT03817814</url>
  </required_header>
  <id_info>
    <org_study_id>18-461</org_study_id>
    <nct_id>NCT03817814</nct_id>
  </id_info>
  <brief_title>Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment</brief_title>
  <official_title>Decisions of Young Women With Breast Cancer Regarding Fertility Preservation Before Cancer Treatment and Family Building After Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <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 will help the researchers learn more about factors that affect the decisions about&#xD;
      fertility preservation and family building made by young women with breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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-reported outcome questionnaire - Fertility Preservation Questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">209</enrollment>
  <condition>Fertility Preservation</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Women with Breast Cancer</arm_group_label>
    <description>This is a cross-sectional survey of young women with breast cancer (YWBC) who received a consultation with an MSK Fertility Nurse Specialist before starting cancer treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>web-based questionnaire</intervention_name>
    <description>Participants will complete a web-based questionnaire examining the decisions patients made about fertility preservation before and after treatment, the factors that influenced their decisions, and the ways in which patients pursue family building after treatment.</description>
    <arm_group_label>Women with Breast Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a cross-sectional survey of YWBC who received a pre-treatment consultation with a&#xD;
        FNS from 2009 through 2018. Participants will complete a one-time web-based questionnaire&#xD;
        examining the decisions they made about FP before and after treatment, the factors that&#xD;
        influenced FP decisions, and the ways in which patients pursue FB after treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer, Stage 0-III&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  18-45 years of age at time of diagnosis&#xD;
&#xD;
          -  Patients that completed their primary breast cancer treatment (surgery, chemotherapy,&#xD;
             radiation therapy). Patients can still be on endocrine therapy, trastuzumab and/or&#xD;
             pertuzumab therapy.&#xD;
&#xD;
          -  Received education and counseling by MSK Fertility Nurse Specialist before beginning&#xD;
             cancer treatment from 2009 through 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with Breast Cancer Regarding Fertility Preservation before Cancer Treatment.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shari Goldfarb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Web-based questionnaire</keyword>
  <keyword>18-461</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>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- 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/NCT03817814
org study id: 18-461
nct id: NCT03817814
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will help the researchers learn more about factors that affect the decisions about
      fertility preservation and family building made by young women with breast cancer.
observational model: Case-Only
time perspective: Prospective
measure: Patient-reported outcome questionnaire - Fertility Preservation Questionnaire
time frame: 1 year
description: Number of patients reporting that fertility tools were recommended to them following their breast cancer diagnosis
arm group label: Women with Breast Cancer
description: This is a cross-sectional survey of young women with breast cancer (YWBC) who received a consultation with an MSK Fertility Nurse Specialist before starting cancer treatment.
intervention type: Behavioral
intervention name: web-based questionnaire
description: Participants will complete a web-based questionnaire examining the decisions patients made about fertility preservation before and after treatment, the factors that influenced their decisions, and the ways in which patients pursue family building after treatment.
arm group label: Women with Breast Cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women with Breast Cancer Regarding Fertility Preservation before Cancer Treatment.
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Shari Goldfarb, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)