xml: <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/NCT05989776</url>
    </required_header>
    <id_info>
      <org_study_id>2022-057</org_study_id>
      <nct_id>NCT05989776</nct_id>
    </id_info>
    <brief_title>Increasing Access to Fertility Preservation for Women With Breast Cancer</brief_title>
    <acronym>EVAPREF</acronym>
    <official_title>Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Paul Sabatier of Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut Claudius Regaud</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Réseau Onco-Occitanie</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Réseau ONCOPL</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Paul Sabatier of Toulouse</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>
        The EVAPREF project aims to increase access to fertility preservation by developing an&#xD;
        approach to improve and evaluate existing information and coordination tools developed by the&#xD;
        Pays-de-la-Loire and Occitanie Regional Cancer networks. First, the investigators will use a&#xD;
        qualitative, iterative, user-centered and participatory approach to improve the current tools&#xD;
        and create training content for the physicians who will use these tools. Second, the&#xD;
        investigators will conduct a randomized stepped wedge trial of women under 40 newly treated&#xD;
        with chemotherapy for breast cancer. The investigators will evaluate the rate of fertility&#xD;
        preservation consultation before and after implementation of the improved tools, over a&#xD;
        30-month period from mid-2023 to the end of 2025. Finally, in a third step, the investigators&#xD;
        will study their approach (context-sensitive implementation analysis) and provide key&#xD;
        elements for its transferability to other contexts and in particular to other Regional Cancer&#xD;
        networks in France.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        With the increase in the number of long-term survivors, interest is shifting from cancer&#xD;
        survival to life and quality of life after cancer. These include consequences of long-term&#xD;
        side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming&#xD;
        increasingly important in cancer management. International recommendations agree on the need&#xD;
        to inform patients prior to treatments about the risk of fertility impairment and refer them&#xD;
        to specialized centers to discuss fertility preservation. However, the literature reveals&#xD;
        suboptimal access to fertility preservation on an international scale, and particularly in&#xD;
        France, making information for patients and oncologists a potential lever for action. The&#xD;
        overall goal is to improve access to fertility preservation and related consultations for&#xD;
        women with breast cancer through the development and evaluation of a combined intervention&#xD;
        targeting the diffusion of information for these patients and brief training for oncologists.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        First, the investigators will use a qualitative, iterative, user-centered and participatory&#xD;
        approach to improve existing information tools and create training content for oncologists&#xD;
        (Aim 1). Second, the investigators will conduct a randomized stepped-wedge trial evaluating&#xD;
        rate of fertility preservation consultation over a 30-month period (Aim 2). The investigators&#xD;
        will include 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one&#xD;
        of 6 participating centers. The primary outcome will be rate of fertility preservation&#xD;
        consultation before and after using the combined intervention (informational brochure for&#xD;
        patients and brief training for oncologists) and will be analyzed using linear regression&#xD;
        models.Third, the investigators will analyze their approach (context-sensitive implementation&#xD;
        analysis) and provide key elements for transferability to other contexts in France (Aim 3).&#xD;
  &#xD;
        Discussion:&#xD;
  &#xD;
        After transitioning to the combined intervention, the investigators will expect to observe an&#xD;
        increase in access to fertility preservation consultation. Particular attention will be paid&#xD;
        to the effect of this intervention on socially disadvantaged women, who are known to be at&#xD;
        greater risk of inappropriate treatment. In addition, the user-centric design principles and&#xD;
        participatory approaches used to optimize the acceptability, usability and feasibility of the&#xD;
        combined intervention will likely enhance its impact, diffusion and sustainability.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>
      <intervention_model_description>The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of recourse to fertility preservation consultation before and after using the combined intervention</measure>
      <time_frame>up to 18 mont post enrollment</time_frame>
      <description>This information will be collected by each regional screening coordination center of the two participating regions from the medical records of patients</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">750</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual care information to fertility preservation counseling</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention: informational brochure for patients and brief training for oncologists</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention is based on information provided to different target populations, using a variety of media, including brochures and videos.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Informational brochure for patients and brief training for oncologists</intervention_name>
      <description>For this randomized, stepped wedge trial, the investigators planned a mixed intervention that targets both health professionals and patients. This intervention will be carried out in its entirety thanks to the working groups made up of health professionals and expert patients that took place before the randomized trial. The intervention for health professionals consists of awareness training. They will be trained (or made aware) at different times, defined by randomization. The intervention for patients consists of a pictorial information brochure and tabular patient decision aid given by trained health professionals.</description>
      <arm_group_label>Intervention: informational brochure for patients and brief training for oncologists</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 and under 40 years of age treated for newly diagnosed breast cancer&#xD;
               and receiving chemotherapy.&#xD;
  &#xD;
            -  People who are able to read the study information poster and the fertility&#xD;
               preservation information brochure in French, either alone or with help from a&#xD;
               caregiver or relative or an interpreter.&#xD;
  &#xD;
            -  People with intellectual disability will be included as long as they are able able to&#xD;
               read the study information poster and the fertility preservation information brochure&#xD;
               in French alone or with help from a caregiver or relative or an interpreter..&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People whose mental health status precludes participation in the study, as determined&#xD;
               by the clinical team.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marie-Anne Durand, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université Toulouse III Paul Sabatier</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marie-Anne Durand, PhD</last_name>
      <phone>0033648038356</phone>
      <email>marie-anne.durand@univ-tlse3.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sébastien Lamy, PhD</last_name>
      <phone>0033684449479</phone>
      <email>lamy.sebastien@iuct-oncopole.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Nantes</name>
        <address>
          <city>Nantes</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Delphine Lauzeille</last_name>
        <email>delphine.lauzeille@chu-nantes.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Claudius Regaud (IUCT-O)</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charlotte Morel</last_name>
        <email>morel@onco-occitanie.frcopole.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Paul Sabatier of Toulouse</investigator_affiliation>
      <investigator_full_name>Marie-Anne Durand</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <keyword>Breast cancer</keyword>
    <keyword>Fertility preservation</keyword>
    <keyword>Information</keyword>
    <keyword>Practitioner training</keyword>
    <keyword>Social inequalities in health</keyword>
    <keyword>Participatory approach</keyword>
    <keyword>Combined intervention</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989776
  org study id: 2022-057
  nct id: NCT05989776
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The EVAPREF project aims to increase access to fertility preservation by developing an
        approach to improve and evaluate existing information and coordination tools developed by the
        Pays-de-la-Loire and Occitanie Regional Cancer networks. First, the investigators will use a
        qualitative, iterative, user-centered and participatory approach to improve the current tools
        and create training content for the physicians who will use these tools. Second, the
        investigators will conduct a randomized stepped wedge trial of women under 40 newly treated
        with chemotherapy for breast cancer. The investigators will evaluate the rate of fertility
        preservation consultation before and after implementation of the improved tools, over a
        30-month period from mid-2023 to the end of 2025. Finally, in a third step, the investigators
        will study their approach (context-sensitive implementation analysis) and provide key
        elements for its transferability to other contexts and in particular to other Regional Cancer
        networks in France.
  Background:
  
        With the increase in the number of long-term survivors, interest is shifting from cancer
        survival to life and quality of life after cancer. These include consequences of long-term
        side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming
        increasingly important in cancer management. International recommendations agree on the need
        to inform patients prior to treatments about the risk of fertility impairment and refer them
        to specialized centers to discuss fertility preservation. However, the literature reveals
        suboptimal access to fertility preservation on an international scale, and particularly in
        France, making information for patients and oncologists a potential lever for action. The
        overall goal is to improve access to fertility preservation and related consultations for
        women with breast cancer through the development and evaluation of a combined intervention
        targeting the diffusion of information for these patients and brief training for oncologists.
  
        Methods:
  
        First, the investigators will use a qualitative, iterative, user-centered and participatory
        approach to improve existing information tools and create training content for oncologists
        (Aim 1). Second, the investigators will conduct a randomized stepped-wedge trial evaluating
        rate of fertility preservation consultation over a 30-month period (Aim 2). The investigators
        will include 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one
        of 6 participating centers. The primary outcome will be rate of fertility preservation
        consultation before and after using the combined intervention (informational brochure for
        patients and brief training for oncologists) and will be analyzed using linear regression
        models.Third, the investigators will analyze their approach (context-sensitive implementation
        analysis) and provide key elements for transferability to other contexts in France (Aim 3).
  
        Discussion:
  
        After transitioning to the combined intervention, the investigators will expect to observe an
        increase in access to fertility preservation consultation. Particular attention will be paid
        to the effect of this intervention on socially disadvantaged women, who are known to be at
        greater risk of inappropriate treatment. In addition, the user-centric design principles and
        participatory approaches used to optimize the acceptability, usability and feasibility of the
        combined intervention will likely enhance its impact, diffusion and sustainability.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators will conduct a randomized stepped-wedge trial multi-site evaluating access to fertility preservation counseling over a 30-month period.
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Rate of recourse to fertility preservation consultation before and after using the combined intervention
  time frame: up to 18 mont post enrollment
  description: This information will be collected by each regional screening coordination center of the two participating regions from the medical records of patients
  arm group label: Usual care
  arm group type: No Intervention
  description: Usual care information to fertility preservation counseling
  arm group label: Intervention: informational brochure for patients and brief training for oncologists
  arm group type: Active Comparator
  description: The intervention is based on information provided to different target populations, using a variety of media, including brochures and videos.
  intervention type: Behavioral
  intervention name: Informational brochure for patients and brief training for oncologists
  description: For this randomized, stepped wedge trial, the investigators planned a mixed intervention that targets both health professionals and patients. This intervention will be carried out in its entirety thanks to the working groups made up of health professionals and expert patients that took place before the randomized trial. The intervention for health professionals consists of awareness training. They will be trained (or made aware) at different times, defined by randomization. The intervention for patients consists of a pictorial information brochure and tabular patient decision aid given by trained health professionals.
  arm group label: Intervention: informational brochure for patients and brief training for oncologists
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Marie-Anne Durand, PhD
  role: Principal Investigator
  affiliation: Université Toulouse III Paul Sabatier
  last name: Marie-Anne Durand, PhD
  phone: 0033648038356
  email: marie-anne.durand@univ-tlse3.fr
  last name: Sébastien Lamy, PhD
  phone: 0033684449479
  email: lamy.sebastien@iuct-oncopole.fr
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: University Paul Sabatier of Toulouse
  investigator full name: Marie-Anne Durand
  investigator title: Researcher
  mesh term: Breast Neoplasms
  sharing ipd: Undecided