<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/NCT03025633</url>
  </required_header>
  <id_info>
    <org_study_id>HullEastYorkshireNHS</org_study_id>
    <nct_id>NCT03025633</nct_id>
  </id_info>
  <brief_title>Explaining the Invisible Using the PEARL System</brief_title>
  <official_title>Explaining the Invisible - A Study to Evaluate the Effectiveness of Delivering Radiotherapy Treatment Information in a Visual Manner Using the PEARL System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side&#xD;
      effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged.&#xD;
      Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The&#xD;
      technique used requires patients to maintain full bladder and empty bowel because they are&#xD;
      next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose&#xD;
      received to healthy organs and tissues as this will reduce side effects. PEARL is commercial&#xD;
      interactive PC software that shows realistic and functional 3D models of Linac's (machines&#xD;
      that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient&#xD;
      treatments including how an individual would be laid on a treatment couch and how the machine&#xD;
      will move and sound during treatment. Additionally PEARL provides the opportunity to look&#xD;
      inside the body to view internal anatomy and show where the radiotherapy treatment is&#xD;
      directed.&#xD;
&#xD;
      Information prior to treatment in radiotherapy is normally given verbally one to one. The&#xD;
      investigators believe this information can be more easily understood if PEARL is used in&#xD;
      conjunction with this verbal exchange. PEARL gives visual and audio representation of the&#xD;
      treatment experience, and demonstrates the reasons behind required preparations.&#xD;
&#xD;
      Research aim is to demonstrate patients who receive information using PEARL have greater&#xD;
      understanding, reduced anxiety and reduced radiation dose. This will be tested using two&#xD;
      groups of patients receiving radiotherapy to the prostate. Group A - Verbal information,&#xD;
      Group B - Verbal information and PEARL demonstration. Data collection is via patient&#xD;
      questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken prior&#xD;
      to each radiotherapy treatment as standard practice. CBCT's are used to locate the treatment&#xD;
      area and assess bladder and bowel status and ensure all of these are suitable to deliver&#xD;
      treatment accurately.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinically significant reduction in the number of CBCT rescans due to protocol non-compliance (resulting from both rectum and bladder non-conformances).</measure>
    <time_frame>7 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Statistically significant difference in bladder volume compliance between the two groups.</measure>
    <time_frame>7 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.</measure>
    <time_frame>7 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased understanding of patients, as perceived by them, regarding the radiotherapy treatment procedure in terms of accurate positioning and need for preparation (rectum/bladder management).</measure>
    <time_frame>7 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Group A - PEARL</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group A will receive a combination of verbal and visual pre-treatment information via the use of PEARL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - NON PEARL</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group B will receive verbal only pre-treatment information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEARL</intervention_name>
    <description>PEARL, is a commercially available PC-based tool that provides a realistic and functional 3D model of a linac and, having uploaded example treatments it can demonstrate the treatment procedure and also relevant anatomical information.</description>
    <arm_group_label>Group A - PEARL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with cancer of the prostate of the following staging: T1-3b, N0-1,&#xD;
             M0.&#xD;
&#xD;
          -  Clinical intention to treat using external radiotherapy based on three local&#xD;
             departmental protocols: TP-CP-97, TP-CP-98 and TP-CP-99. These protocols dictate that&#xD;
             the patients receive VMAT planned treatment, require a full bladder and empty rectum&#xD;
             and require daily localisation using kV cone beam CT (CBCT).&#xD;
&#xD;
          -  Patients consented to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not fulfil the inclusion criteria.&#xD;
&#xD;
          -  Patients diagnosed with depression.&#xD;
&#xD;
          -  Blind patients or patients with severe visual impairment.&#xD;
&#xD;
          -  Patients with reduced understanding due to mental impairment.&#xD;
&#xD;
          -  Patients not willing to consent to the study.&#xD;
&#xD;
          -  Prisoners and young offenders.&#xD;
&#xD;
          -  Patients who are unable to understand verbal explanations given in English.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria A Sykes, BSc (Hons)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull University Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <state>East Yorkshire</state>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PEARL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03025633
org study id: HullEastYorkshireNHS
nct id: NCT03025633
lead sponsor: 
has dmc: No
Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side
      effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged.
      Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The
      technique used requires patients to maintain full bladder and empty bowel because they are
      next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose
      received to healthy organs and tissues as this will reduce side effects. PEARL is commercial
      interactive PC software that shows realistic and functional 3D models of Linac's (machines
      that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient
      treatments including how an individual would be laid on a treatment couch and how the machine
      will move and sound during treatment. Additionally PEARL provides the opportunity to look
      inside the body to view internal anatomy and show where the radiotherapy treatment is
      directed.

      Information prior to treatment in radiotherapy is normally given verbally one to one. The
      investigators believe this information can be more easily understood if PEARL is used in
      conjunction with this verbal exchange. PEARL gives visual and audio representation of the
      treatment experience, and demonstrates the reasons behind required preparations.

      Research aim is to demonstrate patients who receive information using PEARL have greater
      understanding, reduced anxiety and reduced radiation dose. This will be tested using two
      groups of patients receiving radiotherapy to the prostate. Group A - Verbal information,
      Group B - Verbal information and PEARL demonstration. Data collection is via patient
      questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken prior
      to each radiotherapy treatment as standard practice. CBCT's are used to locate the treatment
      area and assess bladder and bowel status and ensure all of these are suitable to deliver
      treatment accurately.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Clinically significant reduction in the number of CBCT rescans due to protocol non-compliance (resulting from both rectum and bladder non-conformances).
time frame: 7 Months
measure: Statistically significant difference in bladder volume compliance between the two groups.
time frame: 7 Months
measure: A statistically significant reduction in treatment-related anxiety in patients, to be assessed using pre-treatment questionnaires.
time frame: 7 Months
measure: Increased understanding of patients, as perceived by them, regarding the radiotherapy treatment procedure in terms of accurate positioning and need for preparation (rectum/bladder management).
time frame: 7 Months
arm group label: Group A - PEARL
arm group type: Other
description: Group A will receive a combination of verbal and visual pre-treatment information via the use of PEARL.
arm group label: Group B - NON PEARL
arm group type: No Intervention
description: Group B will receive verbal only pre-treatment information.
intervention type: Other
intervention name: PEARL
description: PEARL, is a commercially available PC-based tool that provides a realistic and functional 3D model of a linac and, having uploaded example treatments it can demonstrate the treatment procedure and also relevant anatomical information.
arm group label: Group A - PEARL
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria A Sykes, BSc (Hons)
role: Principal Investigator
affiliation: Hull University Teaching Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No