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/NCT05970471</url>
    </required_header>
    <id_info>
      <org_study_id>2023/790</org_study_id>
      <nct_id>NCT05970471</nct_id>
    </id_info>
    <brief_title>Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital</brief_title>
    <acronym>IMPLICATION</acronym>
    <official_title>Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital: Discrete Choice Method to Inform Decision-making by Healthcare Professionals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Besancon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Besancon</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>
        To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have&#xD;
        been established in France. Their goal is to provide the patient with the means to identify,&#xD;
        prevent and limit adverse effects and to know who to refer to in case of a serious adverse&#xD;
        effect, perform a pharmaceutical analysis of the prescription, and participate in the&#xD;
        improvement and evaluation of overall compliance. OPCs are conditioned by the needs,&#xD;
        expectations, and involvement of the patients in their care. In healthcare, patients are&#xD;
        increasingly encouraged to play an active role in the knowledge and management of their&#xD;
        health, express their concerns and preferences, and participate in medical decisions. Thus,&#xD;
        it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the&#xD;
        validated and recommended method of the International Society for Pharmacoeconomics and&#xD;
        Outcomes Research for such a task.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have&#xD;
        been established in France. Their goal is to provide the patient with the means to identify,&#xD;
        prevent and limit adverse effects and to know who to refer to in case of a serious adverse&#xD;
        effect, perform a pharmaceutical analysis of the prescription, and participate in the&#xD;
        improvement and evaluation of overall compliance. OPCs are conditioned by the needs,&#xD;
        expectations, and involvement of the patients in their care. In healthcare, patients are&#xD;
        increasingly encouraged to play an active role in the knowledge and management of their&#xD;
        health, express their concerns and preferences, and participate in medical decisions. Thus,&#xD;
        it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the&#xD;
        validated and recommended method of the International Society for Pharmacoeconomics and&#xD;
        Outcomes Research for such a task.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Preferences of patients</measure>
      <time_frame>12 months</time_frame>
      <description>utility associated with each attribute</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preferences of cargivers and healthcare profesionnals</measure>
      <time_frame>12 months</time_frame>
      <description>utility associated with each attribute</description>
    </secondary_outcome>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Preference, Patient</condition>
    <condition>Pharmacist-Patient Relations</condition>
    <condition>Caregiver</condition>
    <condition>Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          240 patients - 60 Caregivers - 360 healhcare professionnals (pharmacist, oncologists,&#xD;
          general practitioners)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          of patients:&#xD;
  &#xD;
          Main inclusion Criteria:&#xD;
  &#xD;
            -  Patients with lung, prostate breast, prostate or renal cancer;&#xD;
  &#xD;
            -  Patients with oral cancer drugs;&#xD;
  &#xD;
            -  Patients accepted to take par in pharmaceutical consultation in hospital.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Virginie NERICH, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU de Besançon</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Astrid POZET</last_name>
      <phone>+33381218988</phone>
      <email>apozet@chu-besancon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU de Besançon</name>
        <address>
          <city>Besançon</city>
          <zip>25030</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Virginie NERICH, PhD</last_name>
        <email>v1nerich@chu-besancon.fr</email>
      </contact>
      <investigator>
        <last_name>Virginie NERICH, phD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 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>Preference, Patient</keyword>
    <keyword>Pharmacist-Patient Relations</keyword>
    <keyword>Cancer of Colon</keyword>
    <keyword>Cancer, Breast</keyword>
    <keyword>Lung Cancer</keyword>
    <keyword>Prostate Cancer</keyword>
    <keyword>Renal Cancer</keyword>
    <keyword>caregiver</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mouth Neoplasms</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/NCT05970471
  org study id: 2023/790
  nct id: NCT05970471
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have
        been established in France. Their goal is to provide the patient with the means to identify,
        prevent and limit adverse effects and to know who to refer to in case of a serious adverse
        effect, perform a pharmaceutical analysis of the prescription, and participate in the
        improvement and evaluation of overall compliance. OPCs are conditioned by the needs,
        expectations, and involvement of the patients in their care. In healthcare, patients are
        increasingly encouraged to play an active role in the knowledge and management of their
        health, express their concerns and preferences, and participate in medical decisions. Thus,
        it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the
        validated and recommended method of the International Society for Pharmacoeconomics and
        Outcomes Research for such a task.
  To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have
        been established in France. Their goal is to provide the patient with the means to identify,
        prevent and limit adverse effects and to know who to refer to in case of a serious adverse
        effect, perform a pharmaceutical analysis of the prescription, and participate in the
        improvement and evaluation of overall compliance. OPCs are conditioned by the needs,
        expectations, and involvement of the patients in their care. In healthcare, patients are
        increasingly encouraged to play an active role in the knowledge and management of their
        health, express their concerns and preferences, and participate in medical decisions. Thus,
        it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the
        validated and recommended method of the International Society for Pharmacoeconomics and
        Outcomes Research for such a task.
  observational model: Other
  time perspective: Prospective
  measure: Preferences of patients
  time frame: 12 months
  description: utility associated with each attribute
  measure: Preferences of cargivers and healthcare profesionnals
  time frame: 12 months
  description: utility associated with each attribute
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Virginie NERICH, PhD
  role: Principal Investigator
  affiliation: CHU de Besançon
  last name: Astrid POZET
  phone: +33381218988
  email: apozet@chu-besancon.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Mouth Neoplasms