<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/NCT03828318</url>
  </required_header>
  <id_info>
    <org_study_id>MP-05-2019-1628</org_study_id>
    <nct_id>NCT03828318</nct_id>
  </id_info>
  <brief_title>Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial</brief_title>
  <official_title>Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Providence Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier du Quebec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jewish General Hospital</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>
      After undergoing restorative proctectomy for rectal cancer, many patients are left with&#xD;
      significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased&#xD;
      LARS severity correlates with worse perceived global health status and quality of life (QoL).&#xD;
      Among patients undergoing rectal resection with a permanent ostomy, there is evidence that&#xD;
      supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and&#xD;
      knowledge. However, evidence regarding the impact of such interventions in patients who&#xD;
      undergo restorative proctectomy is lacking, despite the latter operation being far more&#xD;
      frequently performed.&#xD;
&#xD;
      The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered&#xD;
      Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy&#xD;
      for rectal cancer.&#xD;
&#xD;
      This is a randomized-controlled muticenter trial that will include patients who have&#xD;
      undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the&#xD;
      rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy&#xD;
      closure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global quality of life (QoL)</measure>
    <time_frame>12 months</time_frame>
    <description>Measured by EORTC QLQ-C30</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Rectal Cancer</condition>
  <condition>Surgery</condition>
  <condition>Patient Activation</condition>
  <condition>Low Anterior Resection</condition>
  <condition>Low Anterior Resection Syndrome</condition>
  <arm_group>
    <arm_group_label>Patient Activation Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Activation Booklet and nursing support for patients with LARS</intervention_name>
    <description>The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.</description>
    <arm_group_label>Patient Activation Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;=18 years-old) who have undergone restorative proctectomy for&#xD;
             neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal&#xD;
             verge) with a diverting ostomy and who are scheduled for ostomy closure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients from whom clear and informed consent cannot be obtained&#xD;
&#xD;
          -  Patients unable to read and comprehend English or French&#xD;
&#xD;
          -  Patients who cannot be contacted by telephone&#xD;
&#xD;
          -  Patients who have undergone major colonic resection in addition to their proctectomy&#xD;
&#xD;
          -  Patients on active chemotherapy or radiotherapy treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Aashiyan Singh, Msc(A)</last_name>
    <phone>514-340-8222</phone>
    <phone_ext>25996</phone_ext>
    <email>aashiyan.singh@ladydavis.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie Demian, Msc</last_name>
    <phone>514-340-8222</phone>
    <phone_ext>25996</phone_ext>
    <email>mdemian@jgh.mcgill.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Caitlin Stafford</last_name>
      <email>CSTAFFORD2@partners.org</email>
    </contact>
    <investigator>
      <last_name>Liliana Bordeianou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Healthcare</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Willis Cao</last_name>
      <email>wcao1@providencehealth.bc.ca</email>
    </contact>
    <investigator>
      <last_name>Carl Brown</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Sabboobeh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marylise Boutros, MD, MSc, FRCSC, FACS. FABCRS</last_name>
      <phone>514-340-8222</phone>
      <phone_ext>6821</phone_ext>
      <email>maryliseboutros@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Sabboobeh</last_name>
      <email>sarah.sabboobeh@ladydavis.ca</email>
    </contact>
    <investigator>
      <last_name>Sender Liberman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Wright</last_name>
      <email>ann.wright@chudequebec.ca</email>
    </contact>
    <investigator>
      <last_name>Sebastien Drolet</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Marylise Boutros</investigator_full_name>
    <investigator_title>Colorectal Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Anterior Resection Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03828318
org study id: MP-05-2019-1628
nct id: NCT03828318
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After undergoing restorative proctectomy for rectal cancer, many patients are left with
      significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased
      LARS severity correlates with worse perceived global health status and quality of life (QoL).
      Among patients undergoing rectal resection with a permanent ostomy, there is evidence that
      supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and
      knowledge. However, evidence regarding the impact of such interventions in patients who
      undergo restorative proctectomy is lacking, despite the latter operation being far more
      frequently performed.

      The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered
      Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy
      for rectal cancer.

      This is a randomized-controlled muticenter trial that will include patients who have
      undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the
      rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy
      closure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Global quality of life (QoL)
time frame: 12 months
description: Measured by EORTC QLQ-C30
arm group label: Patient Activation Arm
arm group type: Experimental
arm group label: Standard Care Arm
arm group type: No Intervention
intervention type: Other
intervention name: Patient Activation Booklet and nursing support for patients with LARS
description: The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
arm group label: Patient Activation Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Aashiyan Singh, Msc(A)
phone: 514-340-8222
phone ext: 25996
email: aashiyan.singh@ladydavis.ca
last name: Marie Demian, Msc
phone: 514-340-8222
phone ext: 25996
email: mdemian@jgh.mcgill.ca
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Dr. Marylise Boutros
investigator title: Colorectal Surgeon
mesh term: Low Anterior Resection Syndrome
mesh term: Syndrome
sharing ipd: No