<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/NCT02992730</url>
  </required_header>
  <id_info>
    <org_study_id>Sheppard_WHIP_Study</org_study_id>
    <nct_id>NCT02992730</nct_id>
  </id_info>
  <brief_title>Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer</brief_title>
  <acronym>WHIP</acronym>
  <official_title>Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.&#xD;
      Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer&#xD;
      deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive&#xD;
      tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,&#xD;
      this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are&#xD;
      more likely to die from their breast cancer as ER positive White women. Preliminary data&#xD;
      suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.&#xD;
      To date, no study has systematically examined psychosocial, healthcare, and biological&#xD;
      factors that predict adherence to hormonal therapy in Black women with breast cancer. To&#xD;
      begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of&#xD;
      422 ER positive Black breast cancer patients recruited from health maintenance organizations&#xD;
      (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific&#xD;
      aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,&#xD;
      etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),&#xD;
      and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)&#xD;
      Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that&#xD;
      predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in&#xD;
      adherence to hormonal therapy which is novel and will increase knowledge about this genetic&#xD;
      factor in Blacks. The study is focused on the time-period (first 3 years) when women appear&#xD;
      to be the most vulnerable to terminating treatment prematurely. A better understanding of&#xD;
      predictors of adherence in Black women may help target interventions and ultimately improve&#xD;
      potentially avoidable adverse breast cancer outcomes in this underserved group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will employ the Adherence Model of Behavior to identify clinical, psychosocial,&#xD;
      and healthcare delivery predictors of longitudinal hormonal therapy adherence in women with&#xD;
      (hormone receptor) HR positive breast cancer. This study is significant because: (1) most&#xD;
      breast cancers in Blacks and Whites are HR positive (~75%)1,27; (2) hormonal therapy is&#xD;
      recommend for all women with HR positive cancer since it reduces recurrence and mortality;&#xD;
      (3) women who adhere to hormonal therapy have lower mortality than those who do not28; (4)&#xD;
      adherence to hormonal therapy is suboptimal, even in HMO settings; (5) current guidelines&#xD;
      recommend at least 5 years of hormonal therapy6; (6) along with Whites, investigators will&#xD;
      examine adherence behaviors in Blacks, a group reported to have poorer outcomes than Whites,&#xD;
      even among HR positive cases of similar stage;) past studies have documented poor adherence&#xD;
      but few have systematically examined reasons for non-adherence. Overall, our results will be&#xD;
      clinically useful and will inform interventions and pharmacogenetics research. For instance,&#xD;
      if investigators find that communication strongly influences adherence, investigators can&#xD;
      develop and implement patient self-efficacy or physician reminder-based interventions to&#xD;
      enhance communication about adherence between patients and clinicians in HMOs. If&#xD;
      investigators find that different factors predict adherence in Blacks versus Whites,&#xD;
      investigators can develop tailored interventions. The PI has extensive experience developing&#xD;
      tailored interventions to improve communication and uptake of chemotherapy in Blacks and&#xD;
      Latinas.The next sections highlight the background that supports the significance of our&#xD;
      research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to hormonal therapy at 36 months post initiation - Survey</measure>
    <time_frame>Baseline to end of followup - 3 years.</time_frame>
    <description>Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy.&#xD;
Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Factors - Medical Record Review</measure>
    <time_frame>Baseline to the end of follow-up - 3 years.</time_frame>
    <description>Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">630</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Women Diagnosed with Breast Cancer</arm_group_label>
    <description>Observational - Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>Women Diagnosed with Breast Cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva Sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants for this study are ER positive women over the age of 21 diagnosed with breast&#xD;
        cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-recurrent invasive breast cancer (AJCC Stages I-IV)&#xD;
&#xD;
          -  Any race&#xD;
&#xD;
          -  English or Spanish speaking and/or reading&#xD;
&#xD;
          -  Initiated hormonal therapy within 12 months of definitive diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HR Negative&#xD;
&#xD;
          -  Under the age of 21&#xD;
&#xD;
          -  Non-English or Spanish Speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication Adherence</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>
  </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/NCT02992730
org study id: Sheppard_WHIP_Study
nct id: NCT02992730
lead sponsor: 
has dmc: No
Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death.
      Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer
      deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive
      tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years,
      this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are
      more likely to die from their breast cancer as ER positive White women. Preliminary data
      suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity.
      To date, no study has systematically examined psychosocial, healthcare, and biological
      factors that predict adherence to hormonal therapy in Black women with breast cancer. To
      begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of
      422 ER positive Black breast cancer patients recruited from health maintenance organizations
      (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific
      aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values,
      etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects),
      and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3)
      Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that
      predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in
      adherence to hormonal therapy which is novel and will increase knowledge about this genetic
      factor in Blacks. The study is focused on the time-period (first 3 years) when women appear
      to be the most vulnerable to terminating treatment prematurely. A better understanding of
      predictors of adherence in Black women may help target interventions and ultimately improve
      potentially avoidable adverse breast cancer outcomes in this underserved group.
Investigators will employ the Adherence Model of Behavior to identify clinical, psychosocial,
      and healthcare delivery predictors of longitudinal hormonal therapy adherence in women with
      (hormone receptor) HR positive breast cancer. This study is significant because: (1) most
      breast cancers in Blacks and Whites are HR positive (~75%)1,27; (2) hormonal therapy is
      recommend for all women with HR positive cancer since it reduces recurrence and mortality;
      (3) women who adhere to hormonal therapy have lower mortality than those who do not28; (4)
      adherence to hormonal therapy is suboptimal, even in HMO settings; (5) current guidelines
      recommend at least 5 years of hormonal therapy6; (6) along with Whites, investigators will
      examine adherence behaviors in Blacks, a group reported to have poorer outcomes than Whites,
      even among HR positive cases of similar stage;) past studies have documented poor adherence
      but few have systematically examined reasons for non-adherence. Overall, our results will be
      clinically useful and will inform interventions and pharmacogenetics research. For instance,
      if investigators find that communication strongly influences adherence, investigators can
      develop and implement patient self-efficacy or physician reminder-based interventions to
      enhance communication about adherence between patients and clinicians in HMOs. If
      investigators find that different factors predict adherence in Blacks versus Whites,
      investigators can develop tailored interventions. The PI has extensive experience developing
      tailored interventions to improve communication and uptake of chemotherapy in Blacks and
      Latinas.The next sections highlight the background that supports the significance of our
      research.
observational model: Cohort
time perspective: Cross-Sectional
measure: Adherence to hormonal therapy at 36 months post initiation - Survey
time frame: Baseline to end of followup - 3 years.
description: Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy.
Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence.
measure: Clinical Factors - Medical Record Review
time frame: Baseline to the end of follow-up - 3 years.
description: Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy.
arm group label: Women Diagnosed with Breast Cancer
description: Observational - Usual Care
intervention type: Behavioral
intervention name: No Intervention
description: No Intervention
arm group label: Women Diagnosed with Breast Cancer
Saliva Sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No