<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/NCT02256670</url>
  </required_header>
  <id_info>
    <org_study_id>1409014658</org_study_id>
    <nct_id>NCT02256670</nct_id>
  </id_info>
  <brief_title>Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial</brief_title>
  <official_title>Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial: Efficacy of a Text-messaging Application in Increasing Adherence With Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study to assess feasibility and patient acceptance of a text message cell phone&#xD;
      application for patients with stage I-III, hormone receptor positive breast cancer who start&#xD;
      adjuvant endocrine therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 75% of breast cancers express the estrogen and/or progesterone receptor&#xD;
      (hormone receptors). The standard of care for women with hormone receptor positive breast&#xD;
      cancer is five to ten years of adjuvant endocrine therapy with drugs such as tamoxifen or&#xD;
      aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant&#xD;
      endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival.&#xD;
      Unfortunately, it is estimated from large population databases that up to 35-40% of patients&#xD;
      may discontinue adjuvant endocrine therapy before completing the recommended 5 years for&#xD;
      various reasons, and non-adherence may reduce survival.&#xD;
&#xD;
      The current protocol is a pilot study in women with hormone receptor positive breast cancer&#xD;
      who are beginning adjuvant endocrine therapy, the purpose of which is to assess the&#xD;
      feasibility of a two-way text messaging application, with goals for a larger randomized&#xD;
      control study to assess if the application will increase adherence and therefore improve&#xD;
      disease free survival. This application includes daily text message medication reminders and&#xD;
      periodic assessment of side effects and barriers to medication adherence and simultaneously&#xD;
      offers assistance for treatment related issues. The investigators will collect information on&#xD;
      QOL and financial burden during the 3 month period and will correlate these metrics with&#xD;
      adherence. This larger randomized control study would be the first such interventional study&#xD;
      to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger&#xD;
      randomized control trial would provide the first longitudinal prospectively collected&#xD;
      information on QOL, financial burden and adherence over the entire 5-year treatment period in&#xD;
      the routine clinical practice setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Patient Acceptance of Text Message Program</measure>
    <time_frame>3 months</time_frame>
    <description>Using self-report surveys to assess feasibility and patient acceptance of text message program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to Endocrine Therapy</measure>
    <time_frame>3 months</time_frame>
    <description>Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking &gt; 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 months</time_frame>
    <description>Measure quality of life (QOL) and financial burden and correlate with medication adherence</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Text Message Application Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Message Application</intervention_name>
    <description>Two-way text messaging application addressing adherence with adjuvant endocrine therapy</description>
    <arm_group_label>Text Message Application Intervention</arm_group_label>
    <other_name>MedAdherence</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed stage I-III, estrogen and/or progesterone&#xD;
             receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom&#xD;
             adjuvant hormonal therapy is indicated following standard NCCN practice guidelines&#xD;
&#xD;
          -  Patients may enter the study before or within one month of starting endocrine&#xD;
             treatment&#xD;
&#xD;
          -  Patients with synchronous bilateral breast cancers are eligible if both tumors are&#xD;
             hormone receptor positive&#xD;
&#xD;
          -  Patient must be able to provide informed consent and agree to:&#xD;
&#xD;
          -  Complete questionnaires according to the pre-specified study design&#xD;
&#xD;
          -  Own a personal cell phone, agree to receive text messages on a monthly basis&#xD;
             (including any costs), and share their personal cell phone number to receive text&#xD;
             message reminder&#xD;
&#xD;
          -  sign consent to allow research staff to contact their pharmacies to determine&#xD;
             prescription refill dates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ductal carcinoma in situ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Mougalian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hormone Receptor Positive</keyword>
  <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/NCT02256670
org study id: 1409014658
nct id: NCT02256670
lead sponsor: 
has dmc: No
Pilot study to assess feasibility and patient acceptance of a text message cell phone
      application for patients with stage I-III, hormone receptor positive breast cancer who start
      adjuvant endocrine therapy.
Approximately 75% of breast cancers express the estrogen and/or progesterone receptor
      (hormone receptors). The standard of care for women with hormone receptor positive breast
      cancer is five to ten years of adjuvant endocrine therapy with drugs such as tamoxifen or
      aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant
      endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival.
      Unfortunately, it is estimated from large population databases that up to 35-40% of patients
      may discontinue adjuvant endocrine therapy before completing the recommended 5 years for
      various reasons, and non-adherence may reduce survival.

      The current protocol is a pilot study in women with hormone receptor positive breast cancer
      who are beginning adjuvant endocrine therapy, the purpose of which is to assess the
      feasibility of a two-way text messaging application, with goals for a larger randomized
      control study to assess if the application will increase adherence and therefore improve
      disease free survival. This application includes daily text message medication reminders and
      periodic assessment of side effects and barriers to medication adherence and simultaneously
      offers assistance for treatment related issues. The investigators will collect information on
      QOL and financial burden during the 3 month period and will correlate these metrics with
      adherence. This larger randomized control study would be the first such interventional study
      to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger
      randomized control trial would provide the first longitudinal prospectively collected
      information on QOL, financial burden and adherence over the entire 5-year treatment period in
      the routine clinical practice setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Acceptance of Text Message Program
time frame: 3 months
description: Using self-report surveys to assess feasibility and patient acceptance of text message program
measure: Adherence to Endocrine Therapy
time frame: 3 months
description: Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking > 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.
measure: Quality of Life
time frame: 3 months
description: Measure quality of life (QOL) and financial burden and correlate with medication adherence
arm group label: Text Message Application Intervention
arm group type: Experimental
description: The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.
intervention type: Behavioral
intervention name: Text Message Application
description: Two-way text messaging application addressing adherence with adjuvant endocrine therapy
arm group label: Text Message Application Intervention
other name: MedAdherence
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Mougalian, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms