<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/NCT04469426</url>
  </required_header>
  <id_info>
    <org_study_id>JGH-2020-2073</org_study_id>
    <nct_id>NCT04469426</nct_id>
  </id_info>
  <brief_title>Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome</brief_title>
  <official_title>Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome (LARS): 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>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</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>
  </sponsors>
  <source>Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 surgery for rectal cancer, many people undergo changes in bowel habits, which may&#xD;
      include the need to empty their bowels more often, accidental leakage of stool or gas, the&#xD;
      sudden urge to go to the bathroom, and more. The term &quot;Low Anterior Resection Syndrome&quot; or&#xD;
      LARS is used to describe these symptoms. LARS has a negative impact on one's quality of life,&#xD;
      and can lead to frustration, as there is no single intervention that has proven to be&#xD;
      effective for LARS, and each patient has to undergo trial and error to find one's solution.&#xD;
      As people struggle with LARS, they describe feeling hopeless and isolated. Peer support is a&#xD;
      supportive relationship between individuals who share common experiences or face similar&#xD;
      challenges. The goal of our study is to evaluate whether use of an online peer support&#xD;
      application with trained mentors who themselves have lived or are living with LARS will&#xD;
      empower patients to better manage their LARS symptoms and improve their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Restorative proctectomy is increasingly being performed for rectal cancer, allowing patients&#xD;
      to avoid permanent colostomy. Low Anterior Resection Syndrome (LARS) refers to a&#xD;
      constellation of bowel symptoms including frequency, urgency, incontinence, and clustering of&#xD;
      bowel movements, that can affect up to 70 to 90% of patients following restorative&#xD;
      proctectomy. Symptoms can last up to 15 years after resection. Currently, there is no&#xD;
      standard treatment for LARS and management is symptom-based and reactive, rather than&#xD;
      proactive. A recent focus group conducted at our institution among LARS patients and&#xD;
      caregivers showed that people living with LARS experience anxiety and isolation due to their&#xD;
      symptoms.&#xD;
&#xD;
      Peer support could be an important psychosocial intervention for people living with LARS,&#xD;
      helping them normalize and validate their experience. Peer support refers to a supportive&#xD;
      relationship between individuals who share common experiences or face similar challenges.&#xD;
      This approach has been associated with positive physical and mental health outcomes for&#xD;
      several patient populations. Our research group conducted a comprehensive review of online&#xD;
      health information for patients with LARS, and demonstrated that existing online resources&#xD;
      were generally of poor quality and lacked important content. With this knowledge, we created&#xD;
      a LARS educational booklet and developed an online app containing LARS educational material&#xD;
      and an interactive forum for online peer support. We are now in an optimal position to&#xD;
      rigorously test the potential effects of this initiative on patient-centered outcomes.&#xD;
&#xD;
      This study is a multicenter, randomized, assessor-blind, parallel-groups, pragmatic trial&#xD;
      involving patients from 5 large colorectal surgery practices (Jewish General Hospital, McGill&#xD;
      University Health Centre-Montreal, QC; Toronto Western Hospital, Mount Sinai Hospital-&#xD;
      Toronto, ON; Saint Paul's Hospital-Vancouver, BC). Participants will be randomized into the&#xD;
      intervention group, who will have access to the online peer support app, and the control&#xD;
      group who will only receive a LARS patient educational booklet. Trained peer support mentors&#xD;
      will moderate discussion in the peer support forum, which will also be monitored daily by&#xD;
      expert health care professionals. Data regarding patient demographics, disease and treatment&#xD;
      characteristics will be obtained via hospital chart review. The primary outcome will be&#xD;
      health- related quality of life at 6 months. Secondary outcomes will be patient activation&#xD;
      and bowel function. We hypothesize that availability of this app (consisting of LARS&#xD;
      information, a closed forum for discussion among peers and trained peer support mentors)&#xD;
      improves health-related quality of life when compared to the comparison group.&#xD;
&#xD;
      Given the significant numbers of patients who suffer from LARS symptoms following restorative&#xD;
      proctectomy and the potential chronic nature of their symptoms, this RCT has the potential to&#xD;
      contribute important knowledge to support patient-centered care of rectal cancer survivors.&#xD;
      The technology addressed in this study (a mobile app for information and online peer support)&#xD;
      is readily accessible and can be relatively easily implemented across large range of&#xD;
      geographic jurisdictions and surgical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">March 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2022</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>European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire</measure>
    <time_frame>1 week before the launch of the app</time_frame>
    <description>Questionnaire measures baseline quality of life before app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessing 'Change' via European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire after 6 months</measure>
    <time_frame>6 months after using the app.</time_frame>
    <description>Questionnaire measures change in quality of life after app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient activation measures</measure>
    <time_frame>1 week before the launch of the app</time_frame>
    <description>Questionnaire measures patient activation before app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient activation measures</measure>
    <time_frame>6 months after using the app.</time_frame>
    <description>Questionnaire measures patient activation after app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel function Low Anterior Resection Syndrome score</measure>
    <time_frame>1 week before the launch of the app</time_frame>
    <description>Questionnaire measures bowel function before app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel function Low Anterior Resection Syndrome score</measure>
    <time_frame>6 months after using the app.</time_frame>
    <description>Questionnaire measures bowel function after app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Patient Empowerment</condition>
  <condition>Low Anterior Resection Syndrome</condition>
  <condition>Colo-rectal Cancer</condition>
  <condition>Peer Group</condition>
  <condition>Patient Satisfaction</condition>
  <condition>Health Attitude</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Informational online app group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have access to an interactive online peer support app developed by the research team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Booklet only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will only have access to the educational booklet on LARS developed by the colorectal research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interactive online informational and peer support app</intervention_name>
    <description>The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor</description>
    <arm_group_label>Informational online app group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  underwent restorative protectomy for Neo-plastic disease of the rectum&#xD;
&#xD;
          -  completed all treatment within the last 3 years&#xD;
&#xD;
          -  patients with minor or major LARS as defined with the LARS score.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active chemotherapy or radiotherapy&#xD;
&#xD;
          -  Major colonic resection in addition to protectomy&#xD;
&#xD;
          -  Cannot be contacted by telephone&#xD;
&#xD;
          -  Unable to read and comprehend English/French&#xD;
&#xD;
          -  Does not have the appropriate interface to access the app&#xD;
&#xD;
          -  Unable to give clear and informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jeongyoon Moon, MD</last_name>
    <phone>5145676370</phone>
    <email>jeongyoon.moon@mail.mcgill.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Sabboobeh, MSc</last_name>
    <phone>5143408222</phone>
    <phone_ext>25996</phone_ext>
    <email>sarah.sabboobeh@ladydavis.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Moon, MD</last_name>
      <phone>5145676370</phone>
      <email>jeongyoon.moon@mail.mcgill.ca</email>
    </contact>
    <contact_backup>
      <last_name>Willis Cao</last_name>
      <phone>604.682.2344</phone>
      <phone_ext>66005</phone_ext>
      <email>wcao1@providencehealth.bc.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Selina Schmocker</last_name>
      <email>Selina.Schmocker@sinaihealth.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taariq Shaikh</last_name>
      <email>Taariq.Shaikh@uhnresearch.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Sabboobeh, MSc</last_name>
      <phone>5143408222</phone>
      <phone_ext>25996</phone_ext>
      <email>sarah.sabboobeh@ladydavis.ca</email>
    </contact>
    <contact_backup>
      <last_name>Jenny Moon, MD</last_name>
      <phone>5145676370</phone>
      <email>jeongyoon.moon@mail.mcgill.ca</email>
    </contact_backup>
  </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>Jenny Moon</last_name>
      <email>jeongyoon.moon@mail.mcgill.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>March 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>colorectal surgery</keyword>
  <keyword>peer support</keyword>
  <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/NCT04469426
org study id: JGH-2020-2073
nct id: NCT04469426
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
After surgery for rectal cancer, many people undergo changes in bowel habits, which may
      include the need to empty their bowels more often, accidental leakage of stool or gas, the
      sudden urge to go to the bathroom, and more. The term "Low Anterior Resection Syndrome" or
      LARS is used to describe these symptoms. LARS has a negative impact on one's quality of life,
      and can lead to frustration, as there is no single intervention that has proven to be
      effective for LARS, and each patient has to undergo trial and error to find one's solution.
      As people struggle with LARS, they describe feeling hopeless and isolated. Peer support is a
      supportive relationship between individuals who share common experiences or face similar
      challenges. The goal of our study is to evaluate whether use of an online peer support
      application with trained mentors who themselves have lived or are living with LARS will
      empower patients to better manage their LARS symptoms and improve their quality of life.
Restorative proctectomy is increasingly being performed for rectal cancer, allowing patients
      to avoid permanent colostomy. Low Anterior Resection Syndrome (LARS) refers to a
      constellation of bowel symptoms including frequency, urgency, incontinence, and clustering of
      bowel movements, that can affect up to 70 to 90% of patients following restorative
      proctectomy. Symptoms can last up to 15 years after resection. Currently, there is no
      standard treatment for LARS and management is symptom-based and reactive, rather than
      proactive. A recent focus group conducted at our institution among LARS patients and
      caregivers showed that people living with LARS experience anxiety and isolation due to their
      symptoms.

      Peer support could be an important psychosocial intervention for people living with LARS,
      helping them normalize and validate their experience. Peer support refers to a supportive
      relationship between individuals who share common experiences or face similar challenges.
      This approach has been associated with positive physical and mental health outcomes for
      several patient populations. Our research group conducted a comprehensive review of online
      health information for patients with LARS, and demonstrated that existing online resources
      were generally of poor quality and lacked important content. With this knowledge, we created
      a LARS educational booklet and developed an online app containing LARS educational material
      and an interactive forum for online peer support. We are now in an optimal position to
      rigorously test the potential effects of this initiative on patient-centered outcomes.

      This study is a multicenter, randomized, assessor-blind, parallel-groups, pragmatic trial
      involving patients from 5 large colorectal surgery practices (Jewish General Hospital, McGill
      University Health Centre-Montreal, QC; Toronto Western Hospital, Mount Sinai Hospital-
      Toronto, ON; Saint Paul's Hospital-Vancouver, BC). Participants will be randomized into the
      intervention group, who will have access to the online peer support app, and the control
      group who will only receive a LARS patient educational booklet. Trained peer support mentors
      will moderate discussion in the peer support forum, which will also be monitored daily by
      expert health care professionals. Data regarding patient demographics, disease and treatment
      characteristics will be obtained via hospital chart review. The primary outcome will be
      health- related quality of life at 6 months. Secondary outcomes will be patient activation
      and bowel function. We hypothesize that availability of this app (consisting of LARS
      information, a closed forum for discussion among peers and trained peer support mentors)
      improves health-related quality of life when compared to the comparison group.

      Given the significant numbers of patients who suffer from LARS symptoms following restorative
      proctectomy and the potential chronic nature of their symptoms, this RCT has the potential to
      contribute important knowledge to support patient-centered care of rectal cancer survivors.
      The technology addressed in this study (a mobile app for information and online peer support)
      is readily accessible and can be relatively easily implemented across large range of
      geographic jurisdictions and surgical settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire
time frame: 1 week before the launch of the app
description: Questionnaire measures baseline quality of life before app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).
measure: Assessing 'Change' via European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire after 6 months
time frame: 6 months after using the app.
description: Questionnaire measures change in quality of life after app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).
measure: Patient activation measures
time frame: 1 week before the launch of the app
description: Questionnaire measures patient activation before app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
measure: Change in Patient activation measures
time frame: 6 months after using the app.
description: Questionnaire measures patient activation after app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
measure: Bowel function Low Anterior Resection Syndrome score
time frame: 1 week before the launch of the app
description: Questionnaire measures bowel function before app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
measure: Bowel function Low Anterior Resection Syndrome score
time frame: 6 months after using the app.
description: Questionnaire measures bowel function after app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
arm group label: Informational online app group
arm group type: Experimental
description: Participants will have access to an interactive online peer support app developed by the research team.
arm group label: Booklet only
arm group type: No Intervention
description: Participants will only have access to the educational booklet on LARS developed by the colorectal research team.
intervention type: Other
intervention name: Interactive online informational and peer support app
description: The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor
arm group label: Informational online app group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeongyoon Moon, MD
phone: 5145676370
email: jeongyoon.moon@mail.mcgill.ca
last name: Sarah Sabboobeh, MSc
phone: 5143408222
phone ext: 25996
email: sarah.sabboobeh@ladydavis.ca
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Dr. Marylise Boutros
investigator title: Assistant Professor
mesh term: Low Anterior Resection Syndrome
mesh term: Syndrome
sharing ipd: No