<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/NCT01694225</url>
  </required_header>
  <id_info>
    <org_study_id>BCC-BRE-12-Adherence</org_study_id>
    <nct_id>NCT01694225</nct_id>
  </id_info>
  <brief_title>Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors</brief_title>
  <official_title>Estimating the Adherence Rate of a Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James Graham Brown Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to establish the feasibility of using a monthly bubble package to improve&#xD;
      compliance rates among women prescribed adjuvant endocrine therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses Bubble packaging to provide a cost effective way to improve compliance and&#xD;
      help direct further interventions to ensure adherence in women on anti-estrogen therapy for&#xD;
      breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 28, 2018</completion_date>
  <primary_completion_date type="Actual">January 28, 2018</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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>bubble package for monthly prescription</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use of bubble packaging for monthly prescription</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bubble packaging for monthly prescription</intervention_name>
    <description>Monthly bubble packaging among women prescribed anti-estrogens</description>
    <arm_group_label>bubble package for monthly prescription</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Estrogen receptor positive (&gt; 1% estrogen expression) by immunohistochemistry&#xD;
&#xD;
          -  Invasive breast cancer (stage I, II, III) or DCIS considered for adjuvant endocrine&#xD;
             therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic disease (stage IV)&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients are unable to fill prescriptions at the BCC pharmacy due to insurance&#xD;
             limitations or personal preference&#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>Elizabeth C Riley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>James Graham Brown Cancer Center- U of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James Graham Brown Cancer Center-University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Elizabeth Riley</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Anti-estrogen therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan for public sharing of individual participant data</ipd_description>
  </patient_data>
  <!-- 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/NCT01694225
org study id: BCC-BRE-12-Adherence
nct id: NCT01694225
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to establish the feasibility of using a monthly bubble package to improve
      compliance rates among women prescribed adjuvant endocrine therapy.
This study uses Bubble packaging to provide a cost effective way to improve compliance and
      help direct further interventions to ensure adherence in women on anti-estrogen therapy for
      breast cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
arm group label: bubble package for monthly prescription
arm group type: Experimental
description: use of bubble packaging for monthly prescription
intervention type: Other
intervention name: bubble packaging for monthly prescription
description: Monthly bubble packaging among women prescribed anti-estrogens
arm group label: bubble package for monthly prescription
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth C Riley, MD
role: Principal Investigator
affiliation: James Graham Brown Cancer Center- U of Louisville
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Elizabeth Riley
investigator title: Associate Professor
mesh term: Breast Neoplasms
sharing ipd: No
ipd description: no plan for public sharing of individual participant data