<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/NCT03761940</url>
  </required_header>
  <id_info>
    <org_study_id>18/0059</org_study_id>
    <nct_id>NCT03761940</nct_id>
  </id_info>
  <brief_title>Health Status of Women With Breast Cancer</brief_title>
  <acronym>OSTaRa</acronym>
  <official_title>An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales&#xD;
      for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost&#xD;
      utility analysis, QALY data is required. This can either be collected within trial or&#xD;
      published data can be used.&#xD;
&#xD;
      In the United Kingdom (UK) there is no up to date QALY data for women with early breast&#xD;
      cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to&#xD;
      date QALY data for women in this cohort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Each subject will complete an EQ5D questionnaire, to allow Quality of Life to be calculated. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Women With Early Breast Cancer</condition>
  <condition>Breast Conserving Surgery</condition>
  <condition>Radiotherapy</condition>
  <arm_group>
    <arm_group_label>Disease free</arm_group_label>
    <description>Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires are disease free.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local recurrences</arm_group_label>
    <description>Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with local recurrence and may be undergoing treatment for this.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distant disease</arm_group_label>
    <description>Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with distant disease and may be undergoing treatment for this.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mastectomy</arm_group_label>
    <description>Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have undergone a mastectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EQ5D questionnaire and a demographic questionnaire</intervention_name>
    <description>questionnaires</description>
    <arm_group_label>Disease free</arm_group_label>
    <arm_group_label>Distant disease</arm_group_label>
    <arm_group_label>Local recurrences</arm_group_label>
    <arm_group_label>Mastectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who satisfy the inclusion exclusion criteria can be selected either from&#xD;
        clinic notes, MDT records, or at clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Over 18 year of age&#xD;
&#xD;
          -  Has had breast cancer, treated with both breast conserving surgery and radiotherapy.&#xD;
&#xD;
          -  Is willing to complete an EQ5D and a demographic questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not speak sufficiently to complete a study questionnaires.&#xD;
&#xD;
          -  Has not already been approached to complete an OSTaRa questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Chris Brew-Graves, MSc</last_name>
    <phone>02076799280</phone>
    <email>c.brew-graves@ucl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>SITU</last_name>
    <email>situ.ostara@ucl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Great Western Hospitals NHS Foundation Trust</name>
      <address>
        <city>Swindon</city>
        <state>Wiltshire</state>
        <zip>SN3 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nathan Coombs</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The OSTaRa study team will adhere to SITU's data sharing policy.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Once the study has been published</ipd_time_frame>
    <ipd_access_criteria>Apply to SITU requesting the study data set. Send your request to situ.trial@ucl.ac.uk</ipd_access_criteria>
    <ipd_url>http://www.ucl.ac.uk/situ</ipd_url>
  </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/NCT03761940
org study id: 18/0059
nct id: NCT03761940
lead sponsor: 
has dmc: No
The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales
      for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost
      utility analysis, QALY data is required. This can either be collected within trial or
      published data can be used.

      In the United Kingdom (UK) there is no up to date QALY data for women with early breast
      cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to
      date QALY data for women in this cohort.
observational model: Other
time perspective: Cross-Sectional
measure: Questionnaire
time frame: 12 months
description: Each subject will complete an EQ5D questionnaire, to allow Quality of Life to be calculated. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value.
arm group label: Disease free
description: Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires are disease free.
arm group label: Local recurrences
description: Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with local recurrence and may be undergoing treatment for this.
arm group label: Distant disease
description: Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with distant disease and may be undergoing treatment for this.
arm group label: Mastectomy
description: Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have undergone a mastectomy.
intervention type: Other
intervention name: EQ5D questionnaire and a demographic questionnaire
description: questionnaires
arm group label: Disease free
arm group label: Distant disease
arm group label: Local recurrences
arm group label: Mastectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Chris Brew-Graves, MSc
phone: 02076799280
email: c.brew-graves@ucl.ac.uk
last name: SITU
email: situ.ostara@ucl.ac.uk
facility: 
status: Recruiting
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: The OSTaRa study team will adhere to SITU's data sharing policy.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Once the study has been published
ipd access criteria: Apply to SITU requesting the study data set. Send your request to situ.trial@ucl.ac.uk
ipd url: http://www.ucl.ac.uk/situ