<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/NCT03818087</url>
  </required_header>
  <id_info>
    <org_study_id>18-634</org_study_id>
    <nct_id>NCT03818087</nct_id>
  </id_info>
  <brief_title>Elevate! : An Elderly Breast Cancer Cohort Study</brief_title>
  <official_title>Elevate! : Improving Outcomes for Older Patients With Breast Cancer:a Longitudinal Cohort and Patient Engagement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Susan G. Komen Breast Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is focused on understanding how the investigators can improve upon breast cancer&#xD;
      and health outcomes for older participants with breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is focused on understanding how the investigators can improve upon breast cancer&#xD;
      and health outcomes for older participants with breast cancer, a group of participants who&#xD;
      often have low risk cancers, but who may do worse than younger participants with the same&#xD;
      kind of cancers. Researchers want to better understand the experiences, barriers, and changes&#xD;
      in physical function older participants with breast cancer have.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adjuvant treatment recommendations</measure>
    <time_frame>7 years</time_frame>
    <description>Report treatment recommendations made to patients enrolled on the cohort</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to hormonal therapy</measure>
    <time_frame>7 years</time_frame>
    <description>We will survey patients on adherence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to treatment and adherence</measure>
    <time_frame>7 years</time_frame>
    <description>We will survey patients on the reasons for adherence and poor adherence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment patterns by age and other characteristics</measure>
    <time_frame>7 years</time_frame>
    <description>We will examine treatment receipt and patterns by subtype of disease</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Elevate</arm_group_label>
    <description>Participants over the age of 70 years old with early-stage breast cancer will be recruited.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Observational cohort</intervention_name>
    <description>Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.</description>
    <arm_group_label>Elevate</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Archival tissue will be collected from participant's prior surgeries and procedures. Some&#xD;
      participants undergoing breast surgery during the five years of participation may have a&#xD;
      sample of fresh tissue taken for research purposes in the operating room. Blood will be&#xD;
      collected at registration and at serial timepoints over a period of five years.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Age 70 or older at the time of diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 70 or older at the time of diagnosis (as indicated by the date of breast biopsy)&#xD;
&#xD;
          -  No more than 67 patients (1/3) will be aged 70-74, with the remaining patients on&#xD;
             study ages 75 or older&#xD;
&#xD;
          -  Any gender is eligible&#xD;
&#xD;
          -  Invasive, non-metastatic breast cancer at diagnosis&#xD;
&#xD;
          -  Those with prior diagnoses of pre-invasive (DCIS) or invasive breast cancer are&#xD;
             eligible as long as their current diagnosis is felt by the treating provider to&#xD;
             represent a NEW non-metastatic primary invasive breast cancer (e.g. someone with a&#xD;
             nodal recurrence from prior disease are not eligible but those with a new&#xD;
             contralateral breast cancer 3 years after a first breast cancer would be eligible)&#xD;
&#xD;
          -  Any breast cancer subtype is allowed&#xD;
&#xD;
          -  Breast cancer-diagnosing biopsy within 90 days of enrollment&#xD;
&#xD;
          -  Receiving or will receive medical oncology care (+/- surgical and radiation oncology&#xD;
             treatments) at the participating center: DFCI/satellites and affiliate sites&#xD;
&#xD;
          -  Patients must be able to understand, speak, and read English or assign a designated&#xD;
             caregiver/proxy for the duration of the study who understands, speaks, and reads&#xD;
             English and who is willing to assist with filling out the survey components which do&#xD;
             not have a validated, translated version. This is because the surveys are not readily&#xD;
             available in multiple languages as a whole, although some components (such as the&#xD;
             Geriatric Assessment and PROs are readily available in multiple languages).&#xD;
&#xD;
          -  If a patient scores 11 or higher on the baseline Orientation-Memory-Concentration Test&#xD;
             done at baseline (Appendix E), a proxy/designee must then be assigned to help the&#xD;
             patient fill out the questionnaires for the duration of the study in order to&#xD;
             participate. The treating provider will also be notified about the cognitive&#xD;
             impairment.&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathological or clinical stage 0, IV disease&#xD;
&#xD;
          -  Those with nodal or metastatic recurrences at the time of enrollment&#xD;
&#xD;
          -  Unable to speak and read English AND no designee who speaks and reads English, as&#xD;
             above&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel A Freedman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel A. Freedman, MD, MPH</last_name>
    <phone>617-632-3800</phone>
    <email>rafreedman@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Northern Light Cancer Care</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Sinclair, DO</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel A Freedman, MD, MPH</last_name>
      <phone>617-632-3800</phone>
      <email>rafreedman@partners.org</email>
    </contact>
    <investigator>
      <last_name>Rachel A Freedman, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lifespan Cancer Institute</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Anne Fenton, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Rachel Freedman, MD, MPH</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</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>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to: [contact information for Sponsor- Investigator or designee].</ipd_access_criteria>
  </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/NCT03818087
org study id: 18-634
nct id: NCT03818087
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is focused on understanding how the investigators can improve upon breast cancer
      and health outcomes for older participants with breast cancer.
This study is focused on understanding how the investigators can improve upon breast cancer
      and health outcomes for older participants with breast cancer, a group of participants who
      often have low risk cancers, but who may do worse than younger participants with the same
      kind of cancers. Researchers want to better understand the experiences, barriers, and changes
      in physical function older participants with breast cancer have.
observational model: Cohort
time perspective: Prospective
measure: Adjuvant treatment recommendations
time frame: 7 years
description: Report treatment recommendations made to patients enrolled on the cohort
measure: Adherence to hormonal therapy
time frame: 7 years
description: We will survey patients on adherence
measure: Barriers to treatment and adherence
time frame: 7 years
description: We will survey patients on the reasons for adherence and poor adherence
measure: Treatment patterns by age and other characteristics
time frame: 7 years
description: We will examine treatment receipt and patterns by subtype of disease
arm group label: Elevate
description: Participants over the age of 70 years old with early-stage breast cancer will be recruited.
intervention type: Behavioral
intervention name: Observational cohort
description: Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
arm group label: Elevate
Archival tissue will be collected from participant's prior surgeries and procedures. Some
      participants undergoing breast surgery during the five years of participation may have a
      sample of fresh tissue taken for research purposes in the operating room. Blood will be
      collected at registration and at serial timepoints over a period of five years.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel A Freedman, MD, MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
last name: Rachel A. Freedman, MD, MPH
phone: 617-632-3800
email: rafreedman@partners.org
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Rachel Freedman, MD, MPH
investigator title: Primary Investigator
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
ipd access criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].