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/NCT06030427</url>
    </required_header>
    <id_info>
      <org_study_id>23-004890</org_study_id>
      <secondary_id>NCI-2023-06407</secondary_id>
      <secondary_id>23-004890</secondary_id>
      <nct_id>NCT06030427</nct_id>
    </id_info>
    <brief_title>A Virtual Mindfulness and Weight Management Program to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors</brief_title>
    <official_title>A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        This clinical trial tests how well a virtual mindfulness and weight management program to&#xD;
        mitigate risk of relapse and improve well being for obese cancer survivors in community&#xD;
        practice and rural areas. Obesity has been linked to increased risk for certain kinds of&#xD;
        cancer and is the second highest modifiable risk factor for cancer. It is also well&#xD;
        documented that having a cancer diagnosis and treatment is a stressful experience. It is&#xD;
        hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the&#xD;
        virtual positive health habits group focused on weight management can improve wellbeing and&#xD;
        distress. Virtual care options continue to extend the reach of medical providers to cancer&#xD;
        survivors, particularly those in the rural setting. A virtual behavioral weight management&#xD;
        program with an integrated mindfulness component may improve mood, coping strategies, stress&#xD;
        management, and weight loss among community practice and rural obese cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To assess if a 12-week virtual weight management program with a mindfulness component will&#xD;
        improve well-being of obese cancer patients with a specific focus on self-reported measures&#xD;
        of depression and anxiety.&#xD;
  &#xD;
        II. To assess if a mindfulness component added to the virtual behavioral weight management&#xD;
        will promote weight loss, improve mood, and increase physical activity.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients participate in a virtual behavioral weight management program with an integrated&#xD;
        mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to&#xD;
        help improve mood, coping strategies, stress management, and weight loss. Patents also&#xD;
        receive patient education handouts, view behavioral educational PowerPoint presentations over&#xD;
        30 minutes, and wear a Fitbit on study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>General anxiety disorder-7 (GAD-7)</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire (PHQ)-8</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of virtual mindfulness and weight management program</measure>
      <time_frame>12 weeks</time_frame>
      <description>Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Assessed by change in body weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition parameter</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily activity levels</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily activity levels</measure>
      <time_frame>Baseline; 12 weeks</time_frame>
      <description>Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
    <condition>Malignant Solid Neoplasm</condition>
    <condition>Obesity-Related Malignant Neoplasm</condition>
    <arm_group>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Dietary Intervention</intervention_name>
      <description>Participate in weight management program</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Educational Intervention</intervention_name>
      <description>Receive patient education handouts</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
      <other_name>Education for Intervention</other_name>
      <other_name>Intervention by Education</other_name>
      <other_name>Intervention through Education</other_name>
      <other_name>Intervention, Educational</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Health Promotion and Education</intervention_name>
      <description>View behavioral educational PowerPoint presentation</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Internet-Based Intervention</intervention_name>
      <description>Complete virtual behavioral weight management with an integrated mindfulness component program</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interview</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Medical Device Usage and Evaluation</intervention_name>
      <description>Wear Fitbit</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Relaxation</intervention_name>
      <description>Complete mindfulness components</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
      <other_name>MBSR</other_name>
      <other_name>Mindful Meditation</other_name>
      <other_name>Mindfulness Meditation</other_name>
      <other_name>Mindfulness-Based Stress Reduction</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Performance Testing</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
      <other_name>Physical Fitness Testing</other_name>
      <other_name>Physical Function Testing</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Supportive care (virtual mindfulness and weight management)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 or over&#xD;
  &#xD;
            -  Identified stage I or stage II cancer in remission&#xD;
  &#xD;
            -  Body mass index (BMI) of 30 or greater&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status scale score of 2 or less&#xD;
  &#xD;
            -  English as a primary language&#xD;
  &#xD;
            -  Has access to a device with a camera (computer, tablet, or video capable phone) that&#xD;
               has wifi and reliable internet access&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to provide consent&#xD;
  &#xD;
            -  ECOG performance status scale score of 3 or above&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Howell, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic Health System-Franciscan Healthcare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Moua Torgerson</last_name>
      <phone>608-392-9142</phone>
      <email>torgerson.moua@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lisa Howell, Ph.D.</last_name>
      <phone>507-284-3985</phone>
      <email>Howell.Lisa@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic Health System-Franciscan Healthcare</name>
        <address>
          <city>La Crosse</city>
          <state>Wisconsin</state>
          <zip>54601</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lisa Howell, Ph.D.</last_name>
        <phone>507-284-3985</phone>
        <email>Howell.Lisa@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Moua Torgerson</last_name>
        <phone>608-392-9142</phone>
        <email>torgerson.moua@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Lisa Howell, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06030427
  org study id: 23-004890
  secondary id: NCI-2023-06407
  secondary id: 23-004890
  nct id: NCT06030427
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial tests how well a virtual mindfulness and weight management program to
        mitigate risk of relapse and improve well being for obese cancer survivors in community
        practice and rural areas. Obesity has been linked to increased risk for certain kinds of
        cancer and is the second highest modifiable risk factor for cancer. It is also well
        documented that having a cancer diagnosis and treatment is a stressful experience. It is
        hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the
        virtual positive health habits group focused on weight management can improve wellbeing and
        distress. Virtual care options continue to extend the reach of medical providers to cancer
        survivors, particularly those in the rural setting. A virtual behavioral weight management
        program with an integrated mindfulness component may improve mood, coping strategies, stress
        management, and weight loss among community practice and rural obese cancer survivors.
  PRIMARY OBJECTIVES:
  
        I. To assess if a 12-week virtual weight management program with a mindfulness component will
        improve well-being of obese cancer patients with a specific focus on self-reported measures
        of depression and anxiety.
  
        II. To assess if a mindfulness component added to the virtual behavioral weight management
        will promote weight loss, improve mood, and increase physical activity.
  
        OUTLINE:
  
        Patients participate in a virtual behavioral weight management program with an integrated
        mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to
        help improve mood, coping strategies, stress management, and weight loss. Patents also
        receive patient education handouts, view behavioral educational PowerPoint presentations over
        30 minutes, and wear a Fitbit on study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: General anxiety disorder-7 (GAD-7)
  time frame: Baseline; 12 weeks
  description: Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety).
  measure: Patient Health Questionnaire (PHQ)-8
  time frame: Baseline; 12 weeks
  description: Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression).
  measure: Feasibility of virtual mindfulness and weight management program
  time frame: 12 weeks
  description: Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12.
  measure: Body weight
  time frame: Baseline; 12 weeks
  description: Assessed by change in body weight
  measure: Body composition parameter
  time frame: Baseline; 12 weeks
  description: Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes.
  measure: Daily activity levels
  time frame: Baseline; 12 weeks
  description: Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)
  measure: Daily activity levels
  time frame: Baseline; 12 weeks
  description: Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.
  arm group label: Supportive care (virtual mindfulness and weight management)
  arm group type: Experimental
  description: Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.
  intervention type: Behavioral
  intervention name: Behavioral Dietary Intervention
  description: Participate in weight management program
  arm group label: Supportive care (virtual mindfulness and weight management)
  intervention type: Other
  intervention name: Educational Intervention
  description: Receive patient education handouts
  arm group label: Supportive care (virtual mindfulness and weight management)
  other name: Education for Intervention
  other name: Intervention by Education
  other name: Intervention through Education
  other name: Intervention, Educational
  intervention type: Other
  intervention name: Health Promotion and Education
  description: View behavioral educational PowerPoint presentation
  arm group label: Supportive care (virtual mindfulness and weight management)
  intervention type: Other
  intervention name: Internet-Based Intervention
  description: Complete virtual behavioral weight management with an integrated mindfulness component program
  arm group label: Supportive care (virtual mindfulness and weight management)
  intervention type: Other
  intervention name: Interview
  description: Ancillary studies
  arm group label: Supportive care (virtual mindfulness and weight management)
  intervention type: Other
  intervention name: Medical Device Usage and Evaluation
  description: Wear Fitbit
  arm group label: Supportive care (virtual mindfulness and weight management)
  intervention type: Behavioral
  intervention name: Mindfulness Relaxation
  description: Complete mindfulness components
  arm group label: Supportive care (virtual mindfulness and weight management)
  other name: MBSR
  other name: Mindful Meditation
  other name: Mindfulness Meditation
  other name: Mindfulness-Based Stress Reduction
  intervention type: Other
  intervention name: Physical Performance Testing
  description: Ancillary studies
  arm group label: Supportive care (virtual mindfulness and weight management)
  other name: Physical Fitness Testing
  other name: Physical Function Testing
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Supportive care (virtual mindfulness and weight management)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lisa Howell, Ph.D.
  role: Principal Investigator
  affiliation: Mayo Clinic Health System-Franciscan Healthcare
  last name: Moua Torgerson
  phone: 608-392-9142
  email: torgerson.moua@mayo.edu
  last name: Lisa Howell, Ph.D.
  phone: 507-284-3985
  email: Howell.Lisa@mayo.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Neoplasms