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/NCT06021093</url>
    </required_header>
    <id_info>
      <org_study_id>NL83528.018.23</org_study_id>
      <nct_id>NCT06021093</nct_id>
    </id_info>
    <brief_title>HYPNAYA Feasibility Study</brief_title>
    <official_title>HYPNotherapy for Improving Distress and Sleep in Adolescents and Young Adults With Cancer; a Feasibility Study (HYPNAYA Feasibility Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
        Adolescents and young adults (AYAs) with a cancer diagnosis experience high levels of stress&#xD;
        during and after treatment. Hypnotherapy as supportive treatment throughout regular cancer&#xD;
        care may reduce symptoms of distress, and improve sleep and health-related quality of life in&#xD;
        AYAs with cancer. The objective of this pilot study is to demonstrate feasibility of&#xD;
        hypnotherapy as supportive treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design: The HYPNAYA feasibility study is an interventional prospective single center&#xD;
        cohort study with pre- and post-measurements. Patients will be consecutively recruited at the&#xD;
        medical oncology department of the Amsterdam UMC. Participants will receive two hypnotherapy&#xD;
        sessions including homebased exercises. At baseline, 8 and 12 weeks after the first&#xD;
        hypnotherapy session, patients will be asked to fill in questionnaires.&#xD;
  &#xD;
        Study population: consecutive AYAs (age 18-39) at the (outpatient) clinic undergoing systemic&#xD;
        treatment or follow-up up to 6 months after finishing medical treatment. Patients that are&#xD;
        actively treated by a psychiatrist, mentally incompetent (based on the opinion of the&#xD;
        treating physician) or previously received hypnotherapy will be excluded.&#xD;
  &#xD;
        Studie intervention: the hypnotherapy will include 2 individual hypnotherapy sessions plus&#xD;
        daily listening to these recorded sessions and to (3 or 4) standardized hypnosis recordings.&#xD;
        The individual sessions will be provided by CF and ET, both certified hypnotherapists and&#xD;
        health care professionals (respectively nurse and physician). Preferably, these sessions take&#xD;
        place during a planned admission for chemotherapy. If preferred by the patient, this can also&#xD;
        take place at the hypnotherapist's office. If preferred by the patient, this can also take&#xD;
        place at the venue of the hypnotherapist. A large part of the first session will be devoted&#xD;
        to answering participants' questions and giving information about hypnosis, followed by&#xD;
        exercises as an introduction to hypnosis. The goal of these exercises is to enable&#xD;
        participants to increase their awareness and abilities in accessing mental imagery and&#xD;
        hypnosis. At the end of the session, information will be provided about the home-based&#xD;
        practice. This will consist of daily listening to prerecorded standardized hypnosis exercises&#xD;
        for three months. These are standardized hypnosis excercises that will be specifically&#xD;
        developed for this study and will be provided to all participants in the study. It will be&#xD;
        explained that daily listening is essential to take full advantage of hypnosis without the&#xD;
        help of a therapist. The second individual session will be scheduled 4-6 weeks later. During&#xD;
        the second meeting, a new hypnosis exercise will be introduced and questions about the&#xD;
        hypnotic exercises will be answered. Suggestions given during the hypnosis exercises will be&#xD;
        focused on relaxation, improvement of sleep, more energy, ego-strengthening and improvement&#xD;
        of feelings of anxiety and depression. It will again be explained that daily listening is&#xD;
        essential to take full advantage of hypnosis without the help of a therapist.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of hypnotherapy as supportive treatment for AYA patients</measure>
      <time_frame>8 weeks</time_frame>
      <description>The primary outcome is feasibility of hypnotherapy as supportive treatment for AYA patients defined as the proportion of patients that complete the 8 weeks of treatment. Complete is defined as attending both individual hypnotherapy sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of included questionnaires</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Feasibility of included questionnaires measured by the proportion of patients that complete all questionnaires pre-intervention (T0) and post-intervention (T3 and T4)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of self-hypnosis</measure>
      <time_frame>8 and 12 weeks</time_frame>
      <description>Feasibility of self-hypnosis measured by the proportion of patients that weekly perform self-hypnosis exercises and use recorded scripts for self-hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported satisfaction of medical hypnosis</measure>
      <time_frame>8 and 12 weeks</time_frame>
      <description>Patient-reported satisfaction of medical hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reach of medical hypnosis</measure>
      <time_frame>1 year</time_frame>
      <description>Reach measured as the number of participants and non-participants from the eligible patient population. Both numbers are retrieved from the central study database completed by the study coordinator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distress (i.e. anxiety)</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distress (i.e. depression)</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear of cancer progression</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6 to 24, higher scores indicate high fear of cancer recurrence).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of sleep</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21), higher scores indicate worse sleep quality).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) questionnaire (range 0 to 100, higher scores indicate better quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in distress (i.e. depression)</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Change in distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression) pre-intervention (T0) and post-intervention (T3).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in distress (i.e. anxiety)</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Change in distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety) pre-intervention (T0) and post-intervention (T3).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fear of cancer progression</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Change in fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6-24, higher score indicate high fear of cancer recurrence) pre-intervention (T0) and post-intervention (T3).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of sleep</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21, higher scores indicate worse sleep quality) pre-intervention (T0) and post-intervention (T3).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in health-related quality of life</measure>
      <time_frame>0, 8 and 12 weeks</time_frame>
      <description>Change in health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) measured by comparing outcomes of questionnaires (range 0 to 100, higher scores indicate better quality of life) pre-intervention (T0) and post-intervention (T3).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>AYA Cancer Patients</condition>
    <arm_group>
      <arm_group_label>Medical Hypnosis</arm_group_label>
      <description>Study intervention: The hypnotherapy will include 2 individual hypnotherapy sessions plus daily listening to these recorded sessions and to (3 or 4) standardized hypnosis recordings. The individual sessions will be provided by CF and ET, both certified hypnotherapists and health care professionals (respectively nurse and physician). Preferably, these sessions take place during a planned admission for chemotherapy. If preferred by the patient, this can also take place at the hypnotherapist's office. If preferred by the patient, this can also take place at the venue of the hypnotherapist. A large part of the first session will be devoted to answering participants' questions and giving information about hypnosis, followed by exercises as an introduction to hypnosis. The goal of these exercises is to enable participants to increase their awareness and abilities in accessing mental imagery and hypnosis. At the end of the session, information will be provided about the home-based practice.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive AYAs (age 18-39) at the (outpatient) clinic undergoing systemic treatment or&#xD;
          follow-up up to 6 months after finishing medical treatment. Patients that are actively&#xD;
          treated by a psychiatrist, mentally incompetent (based on the opinion of the treating&#xD;
          physician) or previously received hypnotherapy will be excluded.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Consecutive AYA patients undergoing systemic treatment or follow-up up to 6 months&#xD;
               after finishing medical treatment at the Amsterdam University Medical Centers in&#xD;
               Amsterdam, will be invited to participate.&#xD;
  &#xD;
            -  The Dutch definition of AYA is patients aged 18-39 years at cancer diagnosis.&#xD;
  &#xD;
            -  All patients need to be fluent in Dutch&#xD;
  &#xD;
            -  Able to understand the informed consent form&#xD;
  &#xD;
            -  Willing to provide written informed consent.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Patients that are actively treated by a psychiatrist will not be able to participate&#xD;
               in this study to prevent interference with ongoing psychiatric treatment.&#xD;
  &#xD;
            -  Patients that are mentally incompetent (based on the opinion of the treating&#xD;
               physician) will be excluded.&#xD;
  &#xD;
            -  Patients that previously received hypnotherapy will also be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Amsterdam UMC, location VUMC</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1081HV</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacqueline M Tromp, MD, PhD</last_name>
        <phone>+31-(0)20-7328149</phone>
        <email>j.m.tromp@amsterdamumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Jasper LA Vleugels, MD, PhD</last_name>
        <phone>+31-(0)62501178</phone>
        <email>j.l.vleugels@amsterdamumc.nl</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Amsterdam UMC, location AMC</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1105AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacqueline M Tromp, MD, PhD</last_name>
        <phone>+31-(0)20-7328149</phone>
        <email>j.m.tromp@amsterdamumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Jasper LA Vleugels, MD, PhD</last_name>
        <phone>+31-(0)625011785</phone>
        <email>j.l.vleugels@amsterdamumc.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <link>
      <url>https://hypnose4comfort.nl/</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>https://skills4comfort.nl/</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 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>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Jacqueline M. Tromp</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Medical Hypnosis</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>No specific plans but open to interested colleagues/persons</ipd_description>
    </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/NCT06021093
  org study id: NL83528.018.23
  nct id: NCT06021093
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adolescents and young adults (AYAs) with a cancer diagnosis experience high levels of stress
        during and after treatment. Hypnotherapy as supportive treatment throughout regular cancer
        care may reduce symptoms of distress, and improve sleep and health-related quality of life in
        AYAs with cancer. The objective of this pilot study is to demonstrate feasibility of
        hypnotherapy as supportive treatment.
  Study design: The HYPNAYA feasibility study is an interventional prospective single center
        cohort study with pre- and post-measurements. Patients will be consecutively recruited at the
        medical oncology department of the Amsterdam UMC. Participants will receive two hypnotherapy
        sessions including homebased exercises. At baseline, 8 and 12 weeks after the first
        hypnotherapy session, patients will be asked to fill in questionnaires.
  
        Study population: consecutive AYAs (age 18-39) at the (outpatient) clinic undergoing systemic
        treatment or follow-up up to 6 months after finishing medical treatment. Patients that are
        actively treated by a psychiatrist, mentally incompetent (based on the opinion of the
        treating physician) or previously received hypnotherapy will be excluded.
  
        Studie intervention: the hypnotherapy will include 2 individual hypnotherapy sessions plus
        daily listening to these recorded sessions and to (3 or 4) standardized hypnosis recordings.
        The individual sessions will be provided by CF and ET, both certified hypnotherapists and
        health care professionals (respectively nurse and physician). Preferably, these sessions take
        place during a planned admission for chemotherapy. If preferred by the patient, this can also
        take place at the hypnotherapist's office. If preferred by the patient, this can also take
        place at the venue of the hypnotherapist. A large part of the first session will be devoted
        to answering participants' questions and giving information about hypnosis, followed by
        exercises as an introduction to hypnosis. The goal of these exercises is to enable
        participants to increase their awareness and abilities in accessing mental imagery and
        hypnosis. At the end of the session, information will be provided about the home-based
        practice. This will consist of daily listening to prerecorded standardized hypnosis exercises
        for three months. These are standardized hypnosis excercises that will be specifically
        developed for this study and will be provided to all participants in the study. It will be
        explained that daily listening is essential to take full advantage of hypnosis without the
        help of a therapist. The second individual session will be scheduled 4-6 weeks later. During
        the second meeting, a new hypnosis exercise will be introduced and questions about the
        hypnotic exercises will be answered. Suggestions given during the hypnosis exercises will be
        focused on relaxation, improvement of sleep, more energy, ego-strengthening and improvement
        of feelings of anxiety and depression. It will again be explained that daily listening is
        essential to take full advantage of hypnosis without the help of a therapist.
  observational model: Cohort
  time perspective: Prospective
  measure: Feasibility of hypnotherapy as supportive treatment for AYA patients
  time frame: 8 weeks
  description: The primary outcome is feasibility of hypnotherapy as supportive treatment for AYA patients defined as the proportion of patients that complete the 8 weeks of treatment. Complete is defined as attending both individual hypnotherapy sessions.
  measure: Feasibility of included questionnaires
  time frame: 0, 8 and 12 weeks
  description: Feasibility of included questionnaires measured by the proportion of patients that complete all questionnaires pre-intervention (T0) and post-intervention (T3 and T4)
  measure: Feasibility of self-hypnosis
  time frame: 8 and 12 weeks
  description: Feasibility of self-hypnosis measured by the proportion of patients that weekly perform self-hypnosis exercises and use recorded scripts for self-hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.
  measure: Patient-reported satisfaction of medical hypnosis
  time frame: 8 and 12 weeks
  description: Patient-reported satisfaction of medical hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.
  measure: Reach of medical hypnosis
  time frame: 1 year
  description: Reach measured as the number of participants and non-participants from the eligible patient population. Both numbers are retrieved from the central study database completed by the study coordinator.
  measure: Distress (i.e. anxiety)
  time frame: 0, 8 and 12 weeks
  description: Distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety).
  measure: Distress (i.e. depression)
  time frame: 0, 8 and 12 weeks
  description: Distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression).
  measure: Fear of cancer progression
  time frame: 0, 8 and 12 weeks
  description: Fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6 to 24, higher scores indicate high fear of cancer recurrence).
  measure: Quality of sleep
  time frame: 0, 8 and 12 weeks
  description: Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21), higher scores indicate worse sleep quality).
  measure: Health-related quality of life
  time frame: 0, 8 and 12 weeks
  description: Health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) questionnaire (range 0 to 100, higher scores indicate better quality of life)
  measure: Change in distress (i.e. depression)
  time frame: 0, 8 and 12 weeks
  description: Change in distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression) pre-intervention (T0) and post-intervention (T3).
  measure: Change in distress (i.e. anxiety)
  time frame: 0, 8 and 12 weeks
  description: Change in distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety) pre-intervention (T0) and post-intervention (T3).
  measure: Change in fear of cancer progression
  time frame: 0, 8 and 12 weeks
  description: Change in fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6-24, higher score indicate high fear of cancer recurrence) pre-intervention (T0) and post-intervention (T3).
  measure: Change in quality of sleep
  time frame: 0, 8 and 12 weeks
  description: Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21, higher scores indicate worse sleep quality) pre-intervention (T0) and post-intervention (T3).
  measure: Change in health-related quality of life
  time frame: 0, 8 and 12 weeks
  description: Change in health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) measured by comparing outcomes of questionnaires (range 0 to 100, higher scores indicate better quality of life) pre-intervention (T0) and post-intervention (T3).
  arm group label: Medical Hypnosis
  description: Study intervention: The hypnotherapy will include 2 individual hypnotherapy sessions plus daily listening to these recorded sessions and to (3 or 4) standardized hypnosis recordings. The individual sessions will be provided by CF and ET, both certified hypnotherapists and health care professionals (respectively nurse and physician). Preferably, these sessions take place during a planned admission for chemotherapy. If preferred by the patient, this can also take place at the hypnotherapist's office. If preferred by the patient, this can also take place at the venue of the hypnotherapist. A large part of the first session will be devoted to answering participants' questions and giving information about hypnosis, followed by exercises as an introduction to hypnosis. The goal of these exercises is to enable participants to increase their awareness and abilities in accessing mental imagery and hypnosis. At the end of the session, information will be provided about the home-based practice.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 39 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  url: https://hypnose4comfort.nl/
  description: Related Info
  url: https://skills4comfort.nl/
  description: Related Info
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Jacqueline M. Tromp
  investigator title: Principal Investigator
  sharing ipd: Undecided
  ipd description: No specific plans but open to interested colleagues/persons