<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/NCT02189278</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00022895</org_study_id>
    <secondary_id>5K07CA138767</secondary_id>
    <nct_id>NCT02189278</nct_id>
  </id_info>
  <brief_title>Improving Adherence to Recommended Surveillance in Breast Cancer Survivors</brief_title>
  <official_title>Improving Adherence to Recommended Surveillance in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evidence-based guidelines recommend cancer surveillance procedures for breast cancer&#xD;
      survivors including physical examination, mammography, breast self-exam, and gynecologic&#xD;
      follow-up. The early detection of recurrent and new cancers can best be achieved through the&#xD;
      combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55%&#xD;
      of breast cancer survivors do not undergo these procedures as recommended. This study tests a&#xD;
      telephone-based psychosocial intervention aimed at improving adherence to recommended&#xD;
      surveillance in breast cancer survivors. The psychosocial intervention for improving&#xD;
      adherence is compared to treatment as usual.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">June 12, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surveillance adherence</measure>
    <time_frame>15 month follow-up</time_frame>
    <description>Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gynecologic exam adherence</measure>
    <time_frame>15 month follow-up</time_frame>
    <description>Receipt of recommended gynecologic exams (coded 0=no, 1=yes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast self-exam adherence</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Frequency of conducting breast self-exams assessed via patient report.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived benefits of surveillance</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Patient reported perceived benefits of breast cancer surveillance</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived barriers to breast cancer surveillance</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Patient reported perceived barriers to completing recommended breast cancer surveillance</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Psychosocial Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Intervention</intervention_name>
    <description>Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.</description>
    <arm_group_label>Psychosocial Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 years of age or older&#xD;
&#xD;
          -  Diagnosis of Stage I to IIIA breast cancer&#xD;
&#xD;
          -  Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or&#xD;
             radiation therapy)&#xD;
&#xD;
          -  No diagnosis of recurrent breast cancer or a new primary cancer&#xD;
&#xD;
          -  Able to provide meaningful consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 21 years of age&#xD;
&#xD;
          -  Unable to provide meaningful consent&#xD;
&#xD;
          -  Surgically treated with bilateral mastectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca A Shelby, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 2, 2018</last_update_submitted>
  <last_update_submitted_qc>October 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Surveillance</keyword>
  <keyword>Mammography</keyword>
  <keyword>Adherence</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/NCT02189278
org study id: Pro00022895
secondary id: 5K07CA138767
nct id: NCT02189278
lead sponsor: 
collaborator: 
has dmc: Yes
Evidence-based guidelines recommend cancer surveillance procedures for breast cancer
      survivors including physical examination, mammography, breast self-exam, and gynecologic
      follow-up. The early detection of recurrent and new cancers can best be achieved through the
      combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55%
      of breast cancer survivors do not undergo these procedures as recommended. This study tests a
      telephone-based psychosocial intervention aimed at improving adherence to recommended
      surveillance in breast cancer survivors. The psychosocial intervention for improving
      adherence is compared to treatment as usual.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Surveillance adherence
time frame: 15 month follow-up
description: Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
measure: Gynecologic exam adherence
time frame: 15 month follow-up
description: Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
measure: Breast self-exam adherence
time frame: 6 month follow-up
description: Frequency of conducting breast self-exams assessed via patient report.
measure: Perceived benefits of surveillance
time frame: 6 month follow-up
description: Patient reported perceived benefits of breast cancer surveillance
measure: Perceived barriers to breast cancer surveillance
time frame: 6 month follow-up
description: Patient reported perceived barriers to completing recommended breast cancer surveillance
arm group label: Psychosocial Intervention
arm group type: Experimental
description: Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
arm group label: Treatment as usual
arm group type: No Intervention
description: Treatment as usual control.
intervention type: Behavioral
intervention name: Psychosocial Intervention
description: Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
arm group label: Psychosocial Intervention
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca A Shelby, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms