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/NCT06038032</url>
    </required_header>
    <id_info>
      <org_study_id>HREBA.CC-23-0209</org_study_id>
      <nct_id>NCT06038032</nct_id>
    </id_info>
    <brief_title>ImpRoving hEalth behaviourS for LIfe After ENdometrial CancEr Trial</brief_title>
    <acronym>RESILIENCE</acronym>
    <official_title>The RESILIENCE Trial: Using a Multimodal and Digital Intervention to Optimize Waist Circumference, Body Composition, and Cardiometabolic Health in Endometrial Cancer Survivors.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alberta</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>
        RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a web-based&#xD;
        health platform, combined with online support from healthcare professionals, to enhance waist&#xD;
        circumference and other vital health outcomes in endometrial cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Individuals diagnosed with endometrial cancer are at an increased risk of cardiac&#xD;
        complications post-treatment, particularly if having overweight or a pronounced waist size.&#xD;
        Adopting healthy habits-like nutritious eating, regular physical activity, and effective&#xD;
        stress management-can mitigate these risks and bolster overall health. However, many cancer&#xD;
        survivors find it challenging to consistently adhere to these health and wellness&#xD;
        recommendations.&#xD;
  &#xD;
        Objective: This study aims to determine the efficacy of a web-based health platform, enriched&#xD;
        with professional guidance, in facilitating healthier lifestyles for endometrial cancer&#xD;
        survivors. This would encompass enhancements in nutrition, physical activity levels, and&#xD;
        mindfulness practices.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        Group 1 (Intervention Group): Participants will engage with the web-based health platform&#xD;
        daily for the initial 16 weeks with expert guidance. Subsequently, participants will navigate&#xD;
        the platform independently for the next 8 weeks.&#xD;
  &#xD;
        Group 2 (Control Group): Participants will initially be provided with standard publicly&#xD;
        accessible health information. After the primary 24-week period, participants will gain&#xD;
        access to the web-based wellness platform.&#xD;
  &#xD;
        Common Elements: Both groups will have access to general health information and will benefit&#xD;
        from supportive calls. To monitor their physical activity, all participants will be equipped&#xD;
        with an activity tracker.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">March 2028</completion_date>
    <primary_completion_date type="Anticipated">March 2028</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>Change from baseline in waist circumference at week 16.</measure>
      <time_frame>Baseline to week 16</time_frame>
      <description>Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in waist circumference at week 24.</measure>
      <time_frame>Baseline and week 24</time_frame>
      <description>Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body weight (in kg) at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in fat mass by DXA at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Percentage fat mass will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Appendicular lean soft tissue will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique. Appendicular lean soft tissue will be adjusted for body weight.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Metabolic syndrome severity Z score will be calculated using waist circumference, blood pressure, high-density lipoprotein cholesterol, triglycerides, and fasting glucose data in sex- and ethnicity-specific equations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>10-year cardiovascular risk will be estimated using sex-specific Framingham risk score based on traditional risk factors. Risk is low if the score is less than 10% and high if it is 20% or higher.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in handgrip muscle strength at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Handgrip strength will be evaluated using a hydraulic handgrip dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Peak oxygen uptake will be measured by gold standard cardiopulmonary exercise testing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.</measure>
      <time_frame>Baseline, week 16, and week 24</time_frame>
      <description>Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire -Endometrial Cancer Module (EORTC QLQ-EN24). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">148</enrollment>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (web-based health platform plus online healthcare professional support), followed by an 8-week maintenance period (web-based platform alone).&#xD;
  At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>My Viva Plan (www.myvivaplan.com)</intervention_name>
      <description>A web-based platform based on preventive self-care that contains tools to monitor nutrition, physical activity, and mental wellbeing will be accessed daily for 24 weeks.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online healthcare professional support</intervention_name>
      <description>Individual and group sessions with a Registered Dietitian, Qualified Exercise professional, and Mental Health Professional for 16 weeks.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years old&#xD;
  &#xD;
            -  History of endometrial cancer (low-grade, early stage).&#xD;
  &#xD;
            -  1 month to 5 years post-surgery and completion of adjuvant treatment.&#xD;
  &#xD;
            -  BMI ≥30 and ≤45 kg/m2.&#xD;
  &#xD;
            -  Able to speak, read and understand English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recurrent or metastatic disease.&#xD;
  &#xD;
            -  Weight fluctuations (±5 kg) within the previous 3 months.&#xD;
  &#xD;
            -  Type 1 diabetes; uncontrolled thyroid disorder or type 2 diabetes.&#xD;
  &#xD;
            -  Taking medications that may alter energy metabolism, body weight and composition.&#xD;
  &#xD;
            -  Self-report &gt;90 moderate-intensity min/week of aerobic physical activity on average&#xD;
               over the past three months.&#xD;
  &#xD;
            -  Potential safety risk with exercise or maximal exercise testing, or physical or&#xD;
               mobility limitations impacting ability to perform physical activity.&#xD;
  &#xD;
            -  Self-report following a structured hypocaloric or a restrictive diet in the past three&#xD;
               months, or self-report currently following a vegan diet but for no more than two&#xD;
               years.&#xD;
  &#xD;
            -  Self-reported history of an eating disorder diagnosed by a physician.&#xD;
  &#xD;
            -  Contraindications for imaging tests, such as pacemakers, pregnancy, and magnetic&#xD;
               implants.&#xD;
        </textblock>
      </criteria>
      <gender>Female</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>Carla Prado, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alberta</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lourdes Ramirez, MSc</last_name>
      <phone>780-492-1151</phone>
      <email>resilience.trial@ualberta.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Toronto</name>
        <address>
          <city>Toronto</city>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Amy A Kirkham, PhD</last_name>
        <phone>416-946-4069</phone>
        <email>amy.kirkham@utoronto.ca</email>
      </contact>
      <investigator>
        <last_name>Amy A Kirkham, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alberta</investigator_affiliation>
      <investigator_full_name>Carla Prado</investigator_full_name>
      <investigator_title>Professor / Campus Alberta Innovates Program (CAIP) Chair in Nutrition, Food and Health</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial 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>
  
  
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/NCT06038032
  org study id: HREBA.CC-23-0209
  nct id: NCT06038032
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  RESILIENCE is 24-week randomized controlled trial that assesses the efficacy of a web-based
        health platform, combined with online support from healthcare professionals, to enhance waist
        circumference and other vital health outcomes in endometrial cancer survivors.
  Background: Individuals diagnosed with endometrial cancer are at an increased risk of cardiac
        complications post-treatment, particularly if having overweight or a pronounced waist size.
        Adopting healthy habits-like nutritious eating, regular physical activity, and effective
        stress management-can mitigate these risks and bolster overall health. However, many cancer
        survivors find it challenging to consistently adhere to these health and wellness
        recommendations.
  
        Objective: This study aims to determine the efficacy of a web-based health platform, enriched
        with professional guidance, in facilitating healthier lifestyles for endometrial cancer
        survivors. This would encompass enhancements in nutrition, physical activity levels, and
        mindfulness practices.
  
        Study Design:
  
        Group 1 (Intervention Group): Participants will engage with the web-based health platform
        daily for the initial 16 weeks with expert guidance. Subsequently, participants will navigate
        the platform independently for the next 8 weeks.
  
        Group 2 (Control Group): Participants will initially be provided with standard publicly
        accessible health information. After the primary 24-week period, participants will gain
        access to the web-based wellness platform.
  
        Common Elements: Both groups will have access to general health information and will benefit
        from supportive calls. To monitor their physical activity, all participants will be equipped
        with an activity tracker.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change from baseline in waist circumference at week 16.
  time frame: Baseline to week 16
  description: Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.
  measure: Change from baseline in waist circumference at week 24.
  time frame: Baseline and week 24
  description: Waist circumference will be measured in centimeters (cm) using an inelastic tape at the level of the iliac crest at the end of normal expiration.
  measure: Change from baseline in body weight (in kg) at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Weight will be measured in kilograms (kg) in triplicate following standardized procedures; average values will be used for analysis.
  measure: Change from baseline in fat mass by DXA at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Percentage fat mass will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique.
  measure: Change from baseline in appendicular lean soft tissue by DXA at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Appendicular lean soft tissue will be measured using dual-energy x-ray absorptiometry (DXA), which is a precise and reliable technique. Appendicular lean soft tissue will be adjusted for body weight.
  measure: Change from baseline in metabolic syndrome by Z score calculation at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Metabolic syndrome severity Z score will be calculated using waist circumference, blood pressure, high-density lipoprotein cholesterol, triglycerides, and fasting glucose data in sex- and ethnicity-specific equations.
  measure: Change from baseline in cardiovascular risk based on the Framingham risk score at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: 10-year cardiovascular risk will be estimated using sex-specific Framingham risk score based on traditional risk factors. Risk is low if the score is less than 10% and high if it is 20% or higher.
  measure: Change from baseline in handgrip muscle strength at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Handgrip strength will be evaluated using a hydraulic handgrip dynamometer.
  measure: Change from baseline in cardiorespiratory fitness by a cardiopulmonary exercise testing (CPET) at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Peak oxygen uptake will be measured by gold standard cardiopulmonary exercise testing.
  measure: Change from baseline in health-related life improvement by the QLQ-C30 at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.
  measure: Change from baseline in health-related life improvement by the QLQ-EN24 at weeks 16 and 24.
  time frame: Baseline, week 16, and week 24
  description: Participants will complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire -Endometrial Cancer Module (EORTC QLQ-EN24). Score ranges from 0 to 100. Higher scores on symptoms and single-items indicate a higher level of symptoms.
  arm group label: Intervention group
  arm group type: Experimental
  description: Participants will receive the intervention for 24 weeks. The first 16 weeks will involve an intensive behavioral program (web-based health platform plus online healthcare professional support), followed by an 8-week maintenance period (web-based platform alone).
  At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.
  arm group label: Control group
  arm group type: No Intervention
  description: At baseline, participants will receive handouts with publicly available health information; they will also wear an activity monitor and receive support telephone calls for the 24 weeks.
  intervention type: Behavioral
  intervention name: My Viva Plan (www.myvivaplan.com)
  description: A web-based platform based on preventive self-care that contains tools to monitor nutrition, physical activity, and mental wellbeing will be accessed daily for 24 weeks.
  arm group label: Intervention group
  intervention type: Behavioral
  intervention name: Online healthcare professional support
  description: Individual and group sessions with a Registered Dietitian, Qualified Exercise professional, and Mental Health Professional for 16 weeks.
  arm group label: Intervention group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carla Prado, PhD
  role: Principal Investigator
  affiliation: University of Alberta
  last name: Lourdes Ramirez, MSc
  phone: 780-492-1151
  email: resilience.trial@ualberta.ca
  facility: 
  contact: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Alberta
  investigator full name: Carla Prado
  investigator title: Professor / Campus Alberta Innovates Program (CAIP) Chair in Nutrition, Food and Health
  mesh term: Endometrial Neoplasms
  sharing ipd: No