<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/NCT03824145</url>
  </required_header>
  <id_info>
    <org_study_id>27600</org_study_id>
    <nct_id>NCT03824145</nct_id>
  </id_info>
  <brief_title>Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer</brief_title>
  <acronym>EDC</acronym>
  <official_title>Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Loyola University Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical College of Wisconsin</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>
      This multi-site study is being conducted to examine dietary and activity patterns, body&#xD;
      composition, blood and quality of life in breast cancer patients. The study will recruit 176&#xD;
      women with MBC in Milwaukee (n=88) and Chicago (n=88).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims/Objectives&#xD;
&#xD;
      AAim 1. To examine the efficacy of the Every Day Counts intervention in producing significant&#xD;
      post-intervention changes in multidimensional QOL in women with MBC.&#xD;
&#xD;
      Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater&#xD;
      improvements in multidimensional QOL compared to women randomized to the attention control&#xD;
      (n=88).&#xD;
&#xD;
      Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body&#xD;
      composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.&#xD;
&#xD;
      Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including&#xD;
      body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.&#xD;
&#xD;
      Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation&#xD;
      and/or Metabolomics are altered with the EDC intervention.&#xD;
&#xD;
      Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p)&#xD;
      that regulate inflammation and/or Metabolomics will be related to QOL improvements and can&#xD;
      identify women more likely to respond to lifestyle changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2022</start_date>
  <completion_date type="Anticipated">February 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2027</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Attention Control</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention adherence</measure>
    <time_frame>4 months</time_frame>
    <description>Number of lifestyle coaching sessions completed out of a possible total of 16 sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention retention</measure>
    <time_frame>4 months</time_frame>
    <description>Number of women who complete the 4-month data collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention retention</measure>
    <time_frame>8 months</time_frame>
    <description>Number of women who complete the 8-month data collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Change from baseline to 4 months</time_frame>
    <description>Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>change from baseline to 8 months</time_frame>
    <description>Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>change from baseline to 4 months</time_frame>
    <description>Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>change from baseline to 8 months</time_frame>
    <description>Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Inflammation - C-Reactive Protein</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Insulin Resistance - Insulin</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Insulin Resistance- Glucose</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Insulin Resistance- C-Peptide</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Adipokine Dysregulation - Adiponectin</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Adipokine Dysregulation - Leptin</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarker Inflammation - Interleukin 6</measure>
    <time_frame>Change from baseline to 4 month</time_frame>
    <description>Analyzed by EVE technologies using standard ELISA kits</description>
  </secondary_outcome>
  <other_outcome>
    <measure>nRNA and Metabolomics - exploratory</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes:&#xD;
1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The attention control participants will receive a home/work organization intervention:&#xD;
Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter.&#xD;
Virtual or weekly phone calls- with a home organization coach with standard prompts.&#xD;
Text messages supporting home/work organization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes.</description>
    <arm_group_label>Immediate Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>The attention control participants will receive a home/work organization intervention:</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥ 18 years), female&#xD;
&#xD;
          -  Confirmed Metastatic Breast Cancer&#xD;
&#xD;
          -  Patients clinically stable with treated brain metastases are eligible&#xD;
&#xD;
          -  Written documentation from their oncologist permitting study participation&#xD;
&#xD;
          -  Determined to be &quot;clinically stable&quot; by their medical oncologist (i.e., no&#xD;
             unintentional weight loss, no new symptoms or change in performance status for the&#xD;
             past 4 weeks, no clinical [including laboratory] or radiologic evidence of disease&#xD;
             progression, no recent or planned change in anti-neoplastic therapies, no reports of&#xD;
             severe pain [≥ Grade 3 per the NCI CTCAE)&#xD;
&#xD;
          -  Life expectancy &gt;6 months&#xD;
&#xD;
             -Written documentation from their oncologist permitting study participation&#xD;
&#xD;
          -  Access to a mobile phone&#xD;
&#xD;
          -  Understand/speak English fluently.&#xD;
&#xD;
          -  Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented&#xD;
             by questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet the above criteria.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melinda Stolley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen OConnell, MSW</last_name>
    <phone>414-955-2114</phone>
    <email>kaoconnell@mcw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen O'Connell, MSW</last_name>
      <phone>414-955-2114</phone>
      <email>kaoconnell@mcw.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Melinda Stolley</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT03824145
org study id: 27600
nct id: NCT03824145
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This multi-site study is being conducted to examine dietary and activity patterns, body
      composition, blood and quality of life in breast cancer patients. The study will recruit 176
      women with MBC in Milwaukee (n=88) and Chicago (n=88).
Aims/Objectives

      AAim 1. To examine the efficacy of the Every Day Counts intervention in producing significant
      post-intervention changes in multidimensional QOL in women with MBC.

      Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater
      improvements in multidimensional QOL compared to women randomized to the attention control
      (n=88).

      Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body
      composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.

      Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including
      body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.

      Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation
      and/or Metabolomics are altered with the EDC intervention.

      Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p)
      that regulate inflammation and/or Metabolomics will be related to QOL improvements and can
      identify women more likely to respond to lifestyle changes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Attention Control
primary purpose: Supportive Care
masking: None (Open Label)
measure: Intervention adherence
time frame: 4 months
description: Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
measure: Intervention retention
time frame: 4 months
description: Number of women who complete the 4-month data collection
measure: Intervention retention
time frame: 8 months
description: Number of women who complete the 8-month data collection
measure: Change in Quality of Life
time frame: Change from baseline to 4 months
description: Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better.
measure: Change in Quality of Life
time frame: change from baseline to 8 months
description: Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better.
measure: Body composition
time frame: change from baseline to 4 months
description: Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
measure: Body composition
time frame: change from baseline to 8 months
description: Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
measure: Serum Biomarker Inflammation - C-Reactive Protein
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Insulin Resistance - Insulin
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Insulin Resistance- Glucose
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Insulin Resistance- C-Peptide
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Adipokine Dysregulation - Adiponectin
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Adipokine Dysregulation - Leptin
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: Serum Biomarker Inflammation - Interleukin 6
time frame: Change from baseline to 4 month
description: Analyzed by EVE technologies using standard ELISA kits
measure: nRNA and Metabolomics - exploratory
time frame: Baseline to 3 months
description: MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer.
arm group label: Immediate Intervention
arm group type: Experimental
description: The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes:
1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating.
arm group label: Attention Control
arm group type: Other
description: The attention control participants will receive a home/work organization intervention:
Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter.
Virtual or weekly phone calls- with a home organization coach with standard prompts.
Text messages supporting home/work organization.
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes.
arm group label: Immediate Intervention
intervention type: Behavioral
intervention name: Attention Control
description: The attention control participants will receive a home/work organization intervention:
arm group label: Attention Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Melinda Stolley, PhD
role: Principal Investigator
affiliation: Principal Investigator
last name: Kathleen OConnell, MSW
phone: 414-955-2114
email: kaoconnell@mcw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Melinda Stolley
investigator title: Professor
mesh term: Breast Neoplasms