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/NCT06008171</url>
    </required_header>
    <id_info>
      <org_study_id>2022-3292</org_study_id>
      <nct_id>NCT06008171</nct_id>
    </id_info>
    <brief_title>Patient Decision Aid for the Treatment of Actinic Keratosis</brief_title>
    <official_title>Patient Decision Aid for the Treatment of Actinic Keratosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Catharina Ziekenhuis Eindhoven</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Maastricht University Medical Center</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 evaluates whether a Patient Decision Aid for the field-directed treatment of&#xD;
        actinic keratosis has an effect on shared decision making and patient satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race.&#xD;
        With an increase in prevalence worldwide due to an aging population and rise of ultraviolet&#xD;
        exposure actinic keratosis are among the most frequently encountered skin lesions in clinical&#xD;
        practice.&#xD;
  &#xD;
        There are many therapeutic modalities for the treatment of actinic keratosis, depending on&#xD;
        multiple factors such as distribution, characteristics, patient preference, side effects,&#xD;
        availability and costs. Treatment options can be divided into: lesion directed therapy en&#xD;
        field directed therapy.&#xD;
  &#xD;
        A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to&#xD;
        better shared-decision making and patient satisfaction which on their part may benefits&#xD;
        treatment compliance and health outcomes and may lead to fewer disputes between patients and&#xD;
        doctors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients with an indication for treatment of field therapy for actinic keratosis will be consulted with patient decision aid or without patient decision aid (conventional)</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in patient satisfaction</measure>
      <time_frame>First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).</time_frame>
      <description>Difference in patient satisfaction making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Decision Evaluation Scales.&#xD;
  This scale uses 15 questions with a maximum score of 75. Higher scores mean more satisfaction and less insecurity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in shared decision making</measure>
      <time_frame>First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).</time_frame>
      <description>Difference in shared decision making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Shared Decision Making-Q-9 questionnaire Dutch version.&#xD;
  This scale uses 9 questions with a maximum score of 45. 0 indicating the lowest and 45 indicating the highest level of perceived shared decision making.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">106</enrollment>
    <condition>Actinic Keratoses</condition>
    <condition>Patient Decision Aid</condition>
    <arm_group>
      <arm_group_label>Patient Decision Aid</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without Patient Decision Aid (conventional)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient Decision Aid</intervention_name>
      <description>A designed tool (by us) that help patients and providers talk and decide together about field-directed treatment options for actinic keratosis.</description>
      <arm_group_label>Patient Decision Aid</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven&#xD;
  &#xD;
            -  age &gt;18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no knowledge of Dutch language&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Klara Mosterd, prof.dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht UMC+</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ellen Oyen, drs</last_name>
      <phone>+31(0)43-3877289</phone>
      <email>ellen.oyen@mumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Klara Mosterd, prof.dr.</last_name>
      <phone>+31(0)43-3877289</phone>
      <email>k.mosterd@mumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ellen Oyen</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ellen Oyen, drs</last_name>
        <phone>+31(0)43-3877289</phone>
        <email>ellen.oyen@mumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Klara Mosterd, prof. dr.</last_name>
        <phone>+31(0)43-3877289</phone>
        <email>k.mosterd@mumc.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Ellen Oyen, drs</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Klara Mosterd, prof. dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>actinic keratosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008171
  org study id: 2022-3292
  nct id: NCT06008171
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates whether a Patient Decision Aid for the field-directed treatment of
        actinic keratosis has an effect on shared decision making and patient satisfaction.
  Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race.
        With an increase in prevalence worldwide due to an aging population and rise of ultraviolet
        exposure actinic keratosis are among the most frequently encountered skin lesions in clinical
        practice.
  
        There are many therapeutic modalities for the treatment of actinic keratosis, depending on
        multiple factors such as distribution, characteristics, patient preference, side effects,
        availability and costs. Treatment options can be divided into: lesion directed therapy en
        field directed therapy.
  
        A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to
        better shared-decision making and patient satisfaction which on their part may benefits
        treatment compliance and health outcomes and may lead to fewer disputes between patients and
        doctors.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients with an indication for treatment of field therapy for actinic keratosis will be consulted with patient decision aid or without patient decision aid (conventional)
  primary purpose: Other
  masking: None (Open Label)
  measure: Difference in patient satisfaction
  time frame: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).
  description: Difference in patient satisfaction making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Decision Evaluation Scales.
  This scale uses 15 questions with a maximum score of 75. Higher scores mean more satisfaction and less insecurity.
  measure: Difference in shared decision making
  time frame: First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).
  description: Difference in shared decision making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Shared Decision Making-Q-9 questionnaire Dutch version.
  This scale uses 9 questions with a maximum score of 45. 0 indicating the lowest and 45 indicating the highest level of perceived shared decision making.
  arm group label: Patient Decision Aid
  arm group type: Active Comparator
  description: Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid.
  arm group label: Without Patient Decision Aid (conventional)
  arm group type: No Intervention
  description: Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.
  intervention type: Other
  intervention name: Patient Decision Aid
  description: A designed tool (by us) that help patients and providers talk and decide together about field-directed treatment options for actinic keratosis.
  arm group label: Patient Decision Aid
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Klara Mosterd, prof.dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  last name: Ellen Oyen, drs
  phone: +31(0)43-3877289
  email: ellen.oyen@mumc.nl
  last name: Klara Mosterd, prof.dr.
  phone: +31(0)43-3877289
  email: k.mosterd@mumc.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis