<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/NCT04491487</url>
  </required_header>
  <id_info>
    <org_study_id>3347</org_study_id>
    <nct_id>NCT04491487</nct_id>
  </id_info>
  <brief_title>Pre-operative Counselling in Laryngectomized Patients</brief_title>
  <official_title>Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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 investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP)&#xD;
      counselling on patients undergoing total laryngectomy in terms of levels of distress,&#xD;
      post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of&#xD;
      the new voice.&#xD;
&#xD;
      This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and&#xD;
      primary tracheoesophageal puncture. Patients will be randomized into two groups: an&#xD;
      Experimental group that will receive a pre-operative SLP counselling session and a Control&#xD;
      group that will not receive it. The investigators will administer a structured interview and&#xD;
      three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress&#xD;
      Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected&#xD;
      between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being&#xD;
      discharged from hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 2, 2021</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Event Scale-revised</measure>
    <time_frame>Between the fifth and seventh post-operative day (T0)</time_frame>
    <description>presence of post-traumatic symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-revised</measure>
    <time_frame>one month after being discharged from hospital (T1)</time_frame>
    <description>presence of post-traumatic symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Event Scale-revised</measure>
    <time_frame>three months after being discharged from hospital (T2)</time_frame>
    <description>presence of post-traumatic symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress Inventory</measure>
    <time_frame>Between the fifth and seventh post-operative day (T0)</time_frame>
    <description>psychological distress levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress Inventory</measure>
    <time_frame>one month after being discharged from hospital (T1)</time_frame>
    <description>psychological distress levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress Inventory</measure>
    <time_frame>three months after being discharged from hospital (T2)</time_frame>
    <description>psychological distress levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Between the fifth and seventh post-operative day (T0)</time_frame>
    <description>anxiety and depression levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>one month after being discharged from hospital (T1)</time_frame>
    <description>anxiety and depression levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>three months after being discharged from hospital (T2)</time_frame>
    <description>anxiety and depression levels</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Total Laryngectomy</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pre-operative counselling</intervention_name>
    <description>pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years and over;&#xD;
&#xD;
          -  patients waiting for TL and primary TEP;&#xD;
&#xD;
          -  patients able and willing to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  positive history for psychiatric or psychological disorders,&#xD;
&#xD;
          -  neurological disorders,&#xD;
&#xD;
          -  ineligibility for voice prosthesis rehabilitation.&#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>Longobardi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Otolaryngology department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A.Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
    <investigator_full_name>LONGOBARDI YLENIA</investigator_full_name>
    <investigator_title>researcher</investigator_title>
  </responsible_party>
  <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/NCT04491487
org study id: 3347
nct id: NCT04491487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP)
      counselling on patients undergoing total laryngectomy in terms of levels of distress,
      post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of
      the new voice.

      This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and
      primary tracheoesophageal puncture. Patients will be randomized into two groups: an
      Experimental group that will receive a pre-operative SLP counselling session and a Control
      group that will not receive it. The investigators will administer a structured interview and
      three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress
      Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected
      between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being
      discharged from hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Impact of Event Scale-revised
time frame: Between the fifth and seventh post-operative day (T0)
description: presence of post-traumatic symptoms
measure: Impact of Event Scale-revised
time frame: one month after being discharged from hospital (T1)
description: presence of post-traumatic symptoms
measure: Impact of Event Scale-revised
time frame: three months after being discharged from hospital (T2)
description: presence of post-traumatic symptoms
measure: Psychological Distress Inventory
time frame: Between the fifth and seventh post-operative day (T0)
description: psychological distress levels
measure: Psychological Distress Inventory
time frame: one month after being discharged from hospital (T1)
description: psychological distress levels
measure: Psychological Distress Inventory
time frame: three months after being discharged from hospital (T2)
description: psychological distress levels
measure: Hospital Anxiety and Depression Scale
time frame: Between the fifth and seventh post-operative day (T0)
description: anxiety and depression levels
measure: Hospital Anxiety and Depression Scale
time frame: one month after being discharged from hospital (T1)
description: anxiety and depression levels
measure: Hospital Anxiety and Depression Scale
time frame: three months after being discharged from hospital (T2)
description: anxiety and depression levels
arm group label: Experimental group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: pre-operative counselling
description: pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Longobardi
role: Principal Investigator
affiliation: Otolaryngology department
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: LONGOBARDI YLENIA
investigator title: researcher
sharing ipd: No