<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/NCT04504201</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 1954</org_study_id>
    <nct_id>NCT04504201</nct_id>
  </id_info>
  <brief_title>Patient-centered Communication About Healthy Weight in Early Breast Cancer</brief_title>
  <official_title>Clinic-based &quot;Patient-Centered Communication About Healthy Weight&quot; (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</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>
      Comorbidities in breast cancer survival account for 49% of overall survival difference&#xD;
      between black and white women. Many obesity-related comorbidities disproportionately affect&#xD;
      black women, therefore pointing to a need to address obesity related comorbidities in&#xD;
      survival disparities in early breast cancer patients. This study tinvestigates how messages&#xD;
      and messaging about healthy weight can be tailored for racially diverse breast cancer&#xD;
      survivors with obesity in order to ensure that clinic-based communications between patients&#xD;
      and their oncology provider are patient-centered and culturally sensitive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this research is to collect essential input for the future development of&#xD;
      a quality improvement intervention to foster &quot;Patient-Center Communication about Healthy&#xD;
      Weigh in clinical practice&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        1. Understand patient-centered perspectives on health weight communication with oncology&#xD;
           clinicians by conducting focus groups&#xD;
&#xD;
           Secondary Objective&#xD;
&#xD;
        2. Understand oncology clinician perspectives on patient center communications for healthy&#xD;
           weight interactions through semi-structured interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">September 29, 2020</completion_date>
  <primary_completion_date type="Actual">September 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feedback from patients regarding healthy weight communication through focus groups</measure>
    <time_frame>3 year</time_frame>
    <description>Summary of conversation based on 5A's Behavioral Change Model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feedback from oncology providers regarding healthy weight communication through semi-structured interview</measure>
    <time_frame>3 year</time_frame>
    <description>Provider suggestions on how to implement 5A's Behavioral change model into patient care</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Early Breast Cancer Patients</arm_group_label>
    <description>Early breast cancer patients (Stage I-III) who have completed primary treatment with a current Body mass index (BMI) over 30.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Oncology Clinicians</arm_group_label>
    <description>Oncology providers associated with community-based practices</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus Group</intervention_name>
    <description>Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.</description>
    <arm_group_label>Early Breast Cancer Patients</arm_group_label>
    <arm_group_label>Medical Oncology Clinicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Breast Cancer patients and Breast oncology providers will be eligible for this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Breast Cancer Cohort:&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  Diagnosed with early breast cancer, Stages I-III&#xD;
&#xD;
          -  Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years&#xD;
&#xD;
          -  Body mass Index of equal or greater than 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot understand and speak English&#xD;
&#xD;
        INclusion Criteria for Oncology provider cohort:&#xD;
&#xD;
          -  Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN&#xD;
&#xD;
          -  associated with community-based practices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten Nyrop, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</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>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/NCT04504201
org study id: LCCC 1954
nct id: NCT04504201
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comorbidities in breast cancer survival account for 49% of overall survival difference
      between black and white women. Many obesity-related comorbidities disproportionately affect
      black women, therefore pointing to a need to address obesity related comorbidities in
      survival disparities in early breast cancer patients. This study tinvestigates how messages
      and messaging about healthy weight can be tailored for racially diverse breast cancer
      survivors with obesity in order to ensure that clinic-based communications between patients
      and their oncology provider are patient-centered and culturally sensitive.
The overall goal of this research is to collect essential input for the future development of
      a quality improvement intervention to foster "Patient-Center Communication about Healthy
      Weigh in clinical practice

      Primary Objective:

        1. Understand patient-centered perspectives on health weight communication with oncology
           clinicians by conducting focus groups

           Secondary Objective

        2. Understand oncology clinician perspectives on patient center communications for healthy
           weight interactions through semi-structured interviews.
observational model: Cohort
time perspective: Prospective
measure: Feedback from patients regarding healthy weight communication through focus groups
time frame: 3 year
description: Summary of conversation based on 5A's Behavioral Change Model
measure: Feedback from oncology providers regarding healthy weight communication through semi-structured interview
time frame: 3 year
description: Provider suggestions on how to implement 5A's Behavioral change model into patient care
arm group label: Early Breast Cancer Patients
description: Early breast cancer patients (Stage I-III) who have completed primary treatment with a current Body mass index (BMI) over 30.
arm group label: Medical Oncology Clinicians
description: Oncology providers associated with community-based practices
intervention type: Other
intervention name: Focus Group
description: Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.
arm group label: Early Breast Cancer Patients
arm group label: Medical Oncology Clinicians
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Kirsten Nyrop, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms