<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/NCT01728506</url>
  </required_header>
  <id_info>
    <org_study_id>VCC 1109</org_study_id>
    <nct_id>NCT01728506</nct_id>
  </id_info>
  <brief_title>An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors</brief_title>
  <acronym>iWEB</acronym>
  <official_title>An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effectiveness of a behavioral weight loss and&#xD;
      exercise intervention delivered via the internet at different cancer centers in New England.&#xD;
      The investigators hypothesize that participants will lose 7% of their body weight. The&#xD;
      research is being done because many women who are treated for breast cancer are overweight&#xD;
      and treatment for breast cancer is often accompanied by weight gain. Individuals who are&#xD;
      overweight may be more likely to have their breast cancer come back. Also women who exercise&#xD;
      at least three hours a week seem to have less chance of their cancer coming back. The&#xD;
      investigators hope to identify an effective weight loss and exercise intervention for breast&#xD;
      cancer survivors that can be easily accessed by many people.&#xD;
&#xD;
      This study is designed to determine the feasibility of conducting a distantly&#xD;
      delivered-weight loss and exercise intervention for patients who have been treated for breast&#xD;
      cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral&#xD;
      weight loss and exercise intervention delivered to overweight/obese breast cancer survivors&#xD;
      in three New England locations.&#xD;
&#xD;
      Participants will be recruited from three New England Cancer Centers - the Vermont Cancer&#xD;
      Center, Norris Cotton Cancer Center at Dartmouth University and the University of&#xD;
      Massachusetts Cancer Center. Participants from each center will undergo baseline assessments&#xD;
      that include diet assessment, body measurements (height, weight, etc), a physical activity&#xD;
      assessment and be asked to complete a series of questionnaires.&#xD;
&#xD;
      Patients that meet the minimum requirements will be enrolled on the study. They will&#xD;
      participate in weekly on-line &quot;chats&quot; about behavioral and diet modifications led by a&#xD;
      qualified facilitator. Participants will also engage in increasing amounts of aerobic&#xD;
      activity (typically walking) throughout the course of the intervention. The intervention&#xD;
      lasts 6 months. At the end of those 6 months, participants will have the same assessments&#xD;
      that were collected at baseline. Following the collection of those assessments, participants&#xD;
      will have completed the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>Change from baseline fesability at 6 months</time_frame>
    <description>Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in diet measures</measure>
    <time_frame>Change from baseline diet measures at 6 months</time_frame>
    <description>Efficacy will be measured using total calories and fat grams before and after the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in anthropometric measures</measure>
    <time_frame>Change from baseline anthropometrics at 6 months</time_frame>
    <description>Change in Weight, BMI, body fat percentage before and after the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in active energy expenditure (ie exercise)</measure>
    <time_frame>Change from baseline active energy expenditure at 6 months</time_frame>
    <description>exercise will be measured using an accelerometer before and after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory biomarkers</measure>
    <time_frame>Change from baseline inflammatory biomarkers at 6 months</time_frame>
    <description>Change in Il-6, hsCRP before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin resistance markers</measure>
    <time_frame>Change from baseline insulin resistance markers at 6 months</time_frame>
    <description>Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Weight Loss &amp; Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm intervention of a 24 week weight loss and exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss and Exercise</intervention_name>
    <description>Internet delivered, behaviorally based weight loss and exercise intervention</description>
    <arm_group_label>Weight Loss &amp; Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  breast cancer diagnosis&#xD;
&#xD;
          -  Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast&#xD;
             cancer 2-12 months prior to study initiation&#xD;
&#xD;
          -  BMI between 27 and 50&#xD;
&#xD;
          -  patient self-report of ability to walk for 10 minutes without interruption or pain&#xD;
&#xD;
          -  access to computer and the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  metastatic disease&#xD;
&#xD;
          -  prior receipt of chemotherapy for other malignancy&#xD;
&#xD;
          -  pregnancy at the time of study entry&#xD;
&#xD;
          -  limited food choices due to celiac sprue or inflammatory bowel disease&#xD;
&#xD;
          -  illiteracy&#xD;
&#xD;
          -  non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim L Dittus, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Hannover</city>
        <state>New Hampshire</state>
        <zip>03755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unviersity of Vermont/Fletcher Allen Health Care</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>May 15, 2015</last_update_submitted>
  <last_update_submitted_qc>May 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Kim Dittus</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>breast cancer survivor</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01728506
org study id: VCC 1109
nct id: NCT01728506
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to test the effectiveness of a behavioral weight loss and
      exercise intervention delivered via the internet at different cancer centers in New England.
      The investigators hypothesize that participants will lose 7% of their body weight. The
      research is being done because many women who are treated for breast cancer are overweight
      and treatment for breast cancer is often accompanied by weight gain. Individuals who are
      overweight may be more likely to have their breast cancer come back. Also women who exercise
      at least three hours a week seem to have less chance of their cancer coming back. The
      investigators hope to identify an effective weight loss and exercise intervention for breast
      cancer survivors that can be easily accessed by many people.

      This study is designed to determine the feasibility of conducting a distantly
      delivered-weight loss and exercise intervention for patients who have been treated for breast
      cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral
      weight loss and exercise intervention delivered to overweight/obese breast cancer survivors
      in three New England locations.

      Participants will be recruited from three New England Cancer Centers - the Vermont Cancer
      Center, Norris Cotton Cancer Center at Dartmouth University and the University of
      Massachusetts Cancer Center. Participants from each center will undergo baseline assessments
      that include diet assessment, body measurements (height, weight, etc), a physical activity
      assessment and be asked to complete a series of questionnaires.

      Patients that meet the minimum requirements will be enrolled on the study. They will
      participate in weekly on-line "chats" about behavioral and diet modifications led by a
      qualified facilitator. Participants will also engage in increasing amounts of aerobic
      activity (typically walking) throughout the course of the intervention. The intervention
      lasts 6 months. At the end of those 6 months, participants will have the same assessments
      that were collected at baseline. Following the collection of those assessments, participants
      will have completed the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility
time frame: Change from baseline fesability at 6 months
description: Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.
measure: Change in diet measures
time frame: Change from baseline diet measures at 6 months
description: Efficacy will be measured using total calories and fat grams before and after the intervention
measure: Change in anthropometric measures
time frame: Change from baseline anthropometrics at 6 months
description: Change in Weight, BMI, body fat percentage before and after the intervention
measure: Change in active energy expenditure (ie exercise)
time frame: Change from baseline active energy expenditure at 6 months
description: exercise will be measured using an accelerometer before and after the intervention
measure: Change in inflammatory biomarkers
time frame: Change from baseline inflammatory biomarkers at 6 months
description: Change in Il-6, hsCRP before and after the intervention
measure: Change in insulin resistance markers
time frame: Change from baseline insulin resistance markers at 6 months
description: Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention
arm group label: Weight Loss & Exercise
arm group type: Experimental
description: Single arm intervention of a 24 week weight loss and exercise intervention.
intervention type: Behavioral
intervention name: Weight Loss and Exercise
description: Internet delivered, behaviorally based weight loss and exercise intervention
arm group label: Weight Loss & Exercise
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kim L Dittus, MD PhD
role: Principal Investigator
affiliation: University of Vermont
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Kim Dittus
investigator title: Assistant Professor
mesh term: Breast Neoplasms
mesh term: Weight Loss