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/NCT06035211</url>
    </required_header>
    <id_info>
      <org_study_id>CHUBX 2022/18</org_study_id>
      <nct_id>NCT06035211</nct_id>
    </id_info>
    <brief_title>Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety</brief_title>
    <acronym>R3DP-A</acronym>
    <official_title>Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Bordeaux</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Bordeaux</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 goal of this clinical trial is to evaluate the impact of showing and handling a&#xD;
        three-dimensional modelization of a patient's tumoral kidney the day before his&#xD;
        nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the&#xD;
        STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D&#xD;
        printed model, and information) using a randomization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Announcement of serious illnesses and especially cancerous disease has major impacts on one's&#xD;
        psychological field. Need of surgery can create even other fears due to its unknown nature.&#xD;
        Use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in&#xD;
        comprehensive care that is way not enough promoted for now. In the field of surgery,&#xD;
        available methods to deal with pre-operative anxiety are massively represented by anxiolytics&#xD;
        drugs, only few other devices were evaluated.&#xD;
  &#xD;
        Technological development in healthcare has seen the rising of three-dimensional media,&#xD;
        especially in surgery, for procedure planning. There is no doubt that this tool is effective&#xD;
        in helping surgeons regarding the studies published within the past few years but there is no&#xD;
        such evidence concerning the benefit for patients. Some authors report improvement of&#xD;
        patients understanding and great satisfaction referring to the usefulness of this tool. But&#xD;
        none of these papers evaluated anxiety.&#xD;
  &#xD;
        The goal of this research is to measure the effect of a personalized three-dimensional model&#xD;
        of patients' tumoral kidney on peri-operative anxiety.&#xD;
  &#xD;
        For this purpose this clinical trial is designed as following: a total of 234 (78*3) patients&#xD;
        planned to have a nephron-sparing surgery for kidney tumor are going to be randomly assign in&#xD;
        3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelled in&#xD;
        three dimensions, but in one of the two groups, the model will be 3D-printed. The control&#xD;
        group will include patients for whom the pre-operative information will be made based on&#xD;
        standardized information letter from the French Urological Association.&#xD;
  &#xD;
        Before surgery, during a preoperative therapeutic education consultation, 3D models will be&#xD;
        presented to the patients according to the allocated study group. All patients will have to&#xD;
        complete questionnaires to assess their anxiety level, their quality of life, their health&#xD;
        literacy level and their understanding of disease and surgical procedure.&#xD;
  &#xD;
        One month after surgery, during the post-operative consultation, patients will also fill out&#xD;
        the different questionnaires to assess their anxiety level, quality of life, and level of&#xD;
        litteracy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire</measure>
      <time_frame>Day-1 from surgery</time_frame>
      <description>The STAI-Etat will be collected before surgery to evaluate the effect of using a personalized three-dimensional model of the patient's kidney during a pre-operative information visit .</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measurement of the progression of the mean anxiety score per arm, by filling STAI-Trait Anxiety self-questionnaire.</measure>
      <time_frame>between baseline and Day 15 post-op</time_frame>
      <description>The progression of the mean anxiety score per arm, measured by STAI-State self-questionnaire at the three follow-up visits in the study and adjusted on the STAI-Trait score at baseline will assess feelings of apprehension, tension, nervousness and worries that the subject usually feels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 between baseline and 15-day post-operative follow-up per arm</measure>
      <time_frame>between baseline and Day 15 post-op</time_frame>
      <description>This questionnaire is a short version version of the European Health Literacy Survey Questionnaire based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of the mean pre-operative score for understanding disease and choice of treatment per arm by filling the WAKE questionnaire</measure>
      <time_frame>Day-1 from surgery</time_frame>
      <description>The WAKE questionnaire is used assess the feeling of understanding of the disease and the choice of treatment preoperatively in each of the three groups, the questionnaire comprises five question on the understanding of the disease . Each dimension has 5 levels : very poor, poor,faire, good, very good or strongly desagree, disagree,neutral,agree or strongly agree</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of the progression of quality of life in each of the three groups by filling the EQ-5D-5L questionnaire</measure>
      <time_frame>between inclusion and Day 15 post-op</time_frame>
      <description>The EQ-5D-5L questionnaire measures participants' quality of life.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of the average duration of the pre-operative information visit in each of the three groups</measure>
      <time_frame>between Day-21 and Day-4 from surgery</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">192</enrollment>
    <condition>Tumoral Kidney</condition>
    <arm_group>
      <arm_group_label>Virtual 3D model group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>exchange time with the virtual 3D model of the kidney to be operated on as information support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3D Printed Model Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>eexchange time with the printed three-dimensional model of the kidney to be operated on as information support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>discussion time with the patient information sheet of the French Association of Urology (AFU) as information support</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>3D model pré-operative education</intervention_name>
      <description>Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group</description>
      <arm_group_label>3D Printed Model Group</arm_group_label>
      <arm_group_label>Virtual 3D model group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (≥ 18 years of age)&#xD;
  &#xD;
            -  Scheduled surgical management by laparoscopic partial nephrectomy with robotic&#xD;
               assistance for kidney tumor&#xD;
  &#xD;
            -  Unilateral kidney tumor or 1st surgery for bilateral involvement&#xD;
  &#xD;
            -  Consent expressed for integration of the UroCCR cohort,&#xD;
  &#xD;
            -  Expressed consent for participation in the 3D Anxiety study.&#xD;
  &#xD;
            -  Patients affiliated or benefiting from a social security plan&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of consent or participation&#xD;
  &#xD;
            -  Difficulty understanding and expressing oneself in French&#xD;
  &#xD;
            -  Patient under guardianship or curatorship&#xD;
  &#xD;
            -  No preoperative CT scan available for 3D modeling&#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>Jean-Christophe BERNHARD, Professeur</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Bordeaux</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jean-Christophe BERNHARD, Professeur</last_name>
      <phone>05 57 82 03 50</phone>
      <email>jean-christophe.bernhard@chu-bordeaux.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU d'ANGERS</name>
        <address>
          <city>Angers</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Pierre BIGOT, Pr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de Bordeaux</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Christophe BERNHARD, Pr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de CAEN</name>
        <address>
          <city>Caen</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Thibaut WAECKEL, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Kremlin-Bicêtre</name>
        <address>
          <city>Le Kremlin-Bicêtre</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sébastien PARIER, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de La CONCEPTION</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Romain BOISSIER, Pr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU de NANTES</name>
        <address>
          <city>Nantes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Stéphane De VERGIE, Dr.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Kidney Neoplasms</keyword>
    <keyword>Renal-Cell Carcinoma</keyword>
    <keyword>Nephron-Sparing Surgery</keyword>
    <keyword>3D Modeling</keyword>
    <keyword>3D Printing</keyword>
    <keyword>Anxiety</keyword>
    <keyword>STAI</keyword>
    <keyword>Personalized Medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</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/NCT06035211
  org study id: CHUBX 2022/18
  nct id: NCT06035211
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the impact of showing and handling a
        three-dimensional modelization of a patient's tumoral kidney the day before his
        nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the
        STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D
        printed model, and information) using a randomization.
  Announcement of serious illnesses and especially cancerous disease has major impacts on one's
        psychological field. Need of surgery can create even other fears due to its unknown nature.
        Use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in
        comprehensive care that is way not enough promoted for now. In the field of surgery,
        available methods to deal with pre-operative anxiety are massively represented by anxiolytics
        drugs, only few other devices were evaluated.
  
        Technological development in healthcare has seen the rising of three-dimensional media,
        especially in surgery, for procedure planning. There is no doubt that this tool is effective
        in helping surgeons regarding the studies published within the past few years but there is no
        such evidence concerning the benefit for patients. Some authors report improvement of
        patients understanding and great satisfaction referring to the usefulness of this tool. But
        none of these papers evaluated anxiety.
  
        The goal of this research is to measure the effect of a personalized three-dimensional model
        of patients' tumoral kidney on peri-operative anxiety.
  
        For this purpose this clinical trial is designed as following: a total of 234 (78*3) patients
        planned to have a nephron-sparing surgery for kidney tumor are going to be randomly assign in
        3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelled in
        three dimensions, but in one of the two groups, the model will be 3D-printed. The control
        group will include patients for whom the pre-operative information will be made based on
        standardized information letter from the French Urological Association.
  
        Before surgery, during a preoperative therapeutic education consultation, 3D models will be
        presented to the patients according to the allocated study group. All patients will have to
        complete questionnaires to assess their anxiety level, their quality of life, their health
        literacy level and their understanding of disease and surgical procedure.
  
        One month after surgery, during the post-operative consultation, patients will also fill out
        the different questionnaires to assess their anxiety level, quality of life, and level of
        litteracy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Measurement of the mean pre-operative anxiety score per arm, by filling the STAI-state self-questionnaire
  time frame: Day-1 from surgery
  description: The STAI-Etat will be collected before surgery to evaluate the effect of using a personalized three-dimensional model of the patient's kidney during a pre-operative information visit .
  measure: Measurement of the progression of the mean anxiety score per arm, by filling STAI-Trait Anxiety self-questionnaire.
  time frame: between baseline and Day 15 post-op
  description: The progression of the mean anxiety score per arm, measured by STAI-State self-questionnaire at the three follow-up visits in the study and adjusted on the STAI-Trait score at baseline will assess feelings of apprehension, tension, nervousness and worries that the subject usually feels.
  measure: Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 between baseline and 15-day post-operative follow-up per arm
  time frame: between baseline and Day 15 post-op
  description: This questionnaire is a short version version of the European Health Literacy Survey Questionnaire based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information .
  measure: Measurement of the mean pre-operative score for understanding disease and choice of treatment per arm by filling the WAKE questionnaire
  time frame: Day-1 from surgery
  description: The WAKE questionnaire is used assess the feeling of understanding of the disease and the choice of treatment preoperatively in each of the three groups, the questionnaire comprises five question on the understanding of the disease . Each dimension has 5 levels : very poor, poor,faire, good, very good or strongly desagree, disagree,neutral,agree or strongly agree
  measure: Measurement of the progression of quality of life in each of the three groups by filling the EQ-5D-5L questionnaire
  time frame: between inclusion and Day 15 post-op
  description: The EQ-5D-5L questionnaire measures participants' quality of life.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additinonally, the questionnaire records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
  measure: Measurement of the average duration of the pre-operative information visit in each of the three groups
  time frame: between Day-21 and Day-4 from surgery
  arm group label: Virtual 3D model group
  arm group type: Active Comparator
  description: exchange time with the virtual 3D model of the kidney to be operated on as information support
  arm group label: 3D Printed Model Group
  arm group type: Active Comparator
  description: eexchange time with the printed three-dimensional model of the kidney to be operated on as information support
  arm group label: Control group
  arm group type: No Intervention
  description: discussion time with the patient information sheet of the French Association of Urology (AFU) as information support
  intervention type: Other
  intervention name: 3D model pré-operative education
  description: Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group
  arm group label: 3D Printed Model Group
  arm group label: Virtual 3D model group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean-Christophe BERNHARD, Professeur
  role: Principal Investigator
  affiliation: University Hospital, Bordeaux
  last name: Jean-Christophe BERNHARD, Professeur
  phone: 05 57 82 03 50
  email: jean-christophe.bernhard@chu-bordeaux.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Anxiety Disorders