<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/NCT02194387</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0230</org_study_id>
    <secondary_id>NCI-2015-00095</secondary_id>
    <secondary_id>2014-0230</secondary_id>
    <nct_id>NCT02194387</nct_id>
  </id_info>
  <brief_title>Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members</brief_title>
  <official_title>Pilot Tests to Optimize the Delivery of Energy Balance Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies different types of energy balance interventions to see how&#xD;
      well they work in increasing the physical activity levels of breast cancer gene-positive&#xD;
      patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or&#xD;
      family members of cancer survivors who are at high risk for cancer. Increasing exercise and&#xD;
      eating healthy foods may help reduce the risk of cancer. Studying how well different types of&#xD;
      interventions work in motivating cancer survivors or high-risk family members to increase&#xD;
      exercise and healthy food choices may help doctors plan the most effective motivational&#xD;
      program for cancer prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach&#xD;
      to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I)&#xD;
      II. To explore the feasibility of using the MOST approach to optimize energy balance&#xD;
      interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive&#xD;
      individuals and their family members. (Pilot II) III. To explore the feasibility of using the&#xD;
      MOST approach to optimize energy balance interventions in a sample of CLL (chronic&#xD;
      lymphocytic leukemia) patients. (Pilot III)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To develop preliminary estimates of effect size and outcome variability for use in&#xD;
      planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and&#xD;
      outcome variability for use in planning future studies. (Pilot II) III. To develop&#xD;
      preliminary estimates of effect size and outcome variability for use in planning future&#xD;
      studies. (Pilot III)&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To examine relationship between individual-level (e.g., distress) and family-level (e.g.,&#xD;
      shared mutation status) variables that are specific to high-risk families and the&#xD;
      effectiveness of energy balance interventions. (Pilot II)&#xD;
&#xD;
      OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups&#xD;
      using a randomized factorial design.&#xD;
&#xD;
      TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week&#xD;
      for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant&#xD;
      responds) from a coach trained in motivational interviewing.&#xD;
&#xD;
      TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and&#xD;
      exercise recommendations daily 1-3 times per day or no text messages.&#xD;
&#xD;
      SOCIAL NETWORKING: Participants are invited to an online forum for study participants&#xD;
      available for 16 weeks or do not receive an invitation for social networking.&#xD;
&#xD;
      SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1&#xD;
      day per week on a website or smartphone application (app).&#xD;
&#xD;
      After completion of study, patients are followed up at 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 17, 2014</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in waist circumference (Pilot I)</measure>
    <time_frame>Baseline to 4 months post-intervention</time_frame>
    <description>Expressed as the mean difference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist circumference (Pilot II)</measure>
    <time_frame>Baseline to 4 months post-intervention</time_frame>
    <description>Expressed as the mean difference.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">337</enrollment>
  <condition>Body Mass Index 25 or Greater</condition>
  <condition>BRCA1 Gene Mutation</condition>
  <condition>BRCA2 Gene Mutation</condition>
  <condition>Breast Carcinoma</condition>
  <condition>Cancer Survivor</condition>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Fatigue</condition>
  <condition>Health Status Unknown</condition>
  <condition>Lynch Syndrome</condition>
  <condition>Ovarian Carcinoma</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.&#xD;
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.&#xD;
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.&#xD;
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Record dietary intake 4-7 days per week</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>intervention, dietary</other_name>
    <other_name>Nutrition Intervention</other_name>
    <other_name>Nutrition Interventions</other_name>
    <other_name>Nutritional Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Record dietary intake 1 day per week</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>intervention, dietary</other_name>
    <other_name>Nutrition Intervention</other_name>
    <other_name>Nutrition Interventions</other_name>
    <other_name>Nutritional Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Receive email coaching</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Participate in social networking</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive telephone coaching</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive text messages</description>
    <arm_group_label>Supportive care (energy balance interventions)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR &lt; 150 minutes of&#xD;
             moderate to vigorous exercise per week OR &lt; 5 servings of fruit and vegetables per day&#xD;
&#xD;
          -  PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised&#xD;
             exercise&#xD;
&#xD;
          -  PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and&#xD;
             receive text messages&#xD;
&#xD;
          -  PILOTS I, II AND III: Able to read and write English&#xD;
&#xD;
          -  PILOTS I, II AND III: Have access to internet&#xD;
&#xD;
          -  PILOT II: BRCA positive OR Lynch syndrome positive individuals&#xD;
&#xD;
          -  PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members&#xD;
             of BRCA-positive individuals OR Lynch syndrome positive individuals&#xD;
&#xD;
          -  PILOT III: CLL survivors&#xD;
&#xD;
          -  PILOT III: Has experienced fatigue within the past seven days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other&#xD;
             assistive device&#xD;
&#xD;
          -  PILOTS I, II AND III: Women who are pregnant (by self-report)&#xD;
&#xD;
          -  PILOTS I, II AND III: Less than 3 months post-surgery&#xD;
&#xD;
          -  PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Karen M Basen-Engquist</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>M D Anderson Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 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>Carcinoma</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Syndrome</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/NCT02194387
org study id: 2014-0230
secondary id: NCI-2015-00095
secondary id: 2014-0230
nct id: NCT02194387
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies different types of energy balance interventions to see how
      well they work in increasing the physical activity levels of breast cancer gene-positive
      patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or
      family members of cancer survivors who are at high risk for cancer. Increasing exercise and
      eating healthy foods may help reduce the risk of cancer. Studying how well different types of
      interventions work in motivating cancer survivors or high-risk family members to increase
      exercise and healthy food choices may help doctors plan the most effective motivational
      program for cancer prevention.
PRIMARY OBJECTIVES:

      I. To explore the feasibility of using the multi-phase optimization strategy (MOST) approach
      to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I)
      II. To explore the feasibility of using the MOST approach to optimize energy balance
      interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive
      individuals and their family members. (Pilot II) III. To explore the feasibility of using the
      MOST approach to optimize energy balance interventions in a sample of CLL (chronic
      lymphocytic leukemia) patients. (Pilot III)

      SECONDARY OBJECTIVES:

      I. To develop preliminary estimates of effect size and outcome variability for use in
      planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and
      outcome variability for use in planning future studies. (Pilot II) III. To develop
      preliminary estimates of effect size and outcome variability for use in planning future
      studies. (Pilot III)

      EXPLORATORY OBJECTIVES:

      I. To examine relationship between individual-level (e.g., distress) and family-level (e.g.,
      shared mutation status) variables that are specific to high-risk families and the
      effectiveness of energy balance interventions. (Pilot II)

      OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups
      using a randomized factorial design.

      TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week
      for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant
      responds) from a coach trained in motivational interviewing.

      TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and
      exercise recommendations daily 1-3 times per day or no text messages.

      SOCIAL NETWORKING: Participants are invited to an online forum for study participants
      available for 16 weeks or do not receive an invitation for social networking.

      SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1
      day per week on a website or smartphone application (app).

      After completion of study, patients are followed up at 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in waist circumference (Pilot I)
time frame: Baseline to 4 months post-intervention
description: Expressed as the mean difference.
measure: Change in waist circumference (Pilot II)
time frame: Baseline to 4 months post-intervention
description: Expressed as the mean difference.
arm group label: Supportive care (energy balance interventions)
arm group type: Experimental
description: TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.
intervention type: Dietary Supplement
intervention name: Dietary Intervention
description: Record dietary intake 4-7 days per week
arm group label: Supportive care (energy balance interventions)
other name: Dietary Modification
other name: intervention, dietary
other name: Nutrition Intervention
other name: Nutrition Interventions
other name: Nutritional Interventions
intervention type: Dietary Supplement
intervention name: Dietary Intervention
description: Record dietary intake 1 day per week
arm group label: Supportive care (energy balance interventions)
other name: Dietary Modification
other name: intervention, dietary
other name: Nutrition Intervention
other name: Nutrition Interventions
other name: Nutritional Interventions
intervention type: Other
intervention name: Internet-Based Intervention
description: Receive email coaching
arm group label: Supportive care (energy balance interventions)
intervention type: Other
intervention name: Internet-Based Intervention
description: Participate in social networking
arm group label: Supportive care (energy balance interventions)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive care (energy balance interventions)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive care (energy balance interventions)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive telephone coaching
arm group label: Supportive care (energy balance interventions)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive text messages
arm group label: Supportive care (energy balance interventions)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karen M Basen-Engquist
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: M D Anderson Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Overweight
mesh term: Syndrome