<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/NCT03007641</url>
  </required_header>
  <id_info>
    <org_study_id>16-8003</org_study_id>
    <nct_id>NCT03007641</nct_id>
  </id_info>
  <brief_title>Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient</brief_title>
  <official_title>Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Comprehensive Cancer Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to enhance the care of older metastatic breast cancer (MBC)&#xD;
      patients by increasing awareness among oncology providers as to the unique aspects of care&#xD;
      required for older patients. The goal of the study is to educate providers on the utility of&#xD;
      geriatric assessment in guiding therapy of older metastatic breast cancer patients. The&#xD;
      investigators will also assess the feasibility and benefit of incorporating geriatric&#xD;
      self-assessments into clinical practice. The study will include three phases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older oncology patients pose a significant treatment challenge due to poor chemotherapy&#xD;
      tolerance as a result of underlying co-morbidities, lack of social support, and diminished&#xD;
      functional reserve. Oncologists are faced with the challenge of differentiating between&#xD;
      patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's&#xD;
      biologic rather than chronologic age.&#xD;
&#xD;
      A significant challenge that surrounds the treatment of the older metastatic breast cancer&#xD;
      (MBC) patient in particular, lies in the lack of evidence based clinical data to guide the&#xD;
      oncologist in determination of a treatment plan. This is a result of under representation of&#xD;
      older patients in clinical trials. Due to these challenges a thorough evaluation of the older&#xD;
      patient is recommended prior to initiation of anti-cancer therapy.&#xD;
&#xD;
      The purpose of this research study is to enhance the care of the older MBC patient by&#xD;
      increasing awareness among oncology providers as to the unique aspects of care required for&#xD;
      older patients. The goal of the study is to educate providers on the utility of geriatric&#xD;
      assessment in guiding therapy of older metastatic breast cancer patients. The investigators&#xD;
      will also assess the feasibility and benefit of incorporating geriatric self-assessments into&#xD;
      clinical practice. The study will include three phases:&#xD;
&#xD;
        1. Needs assessments - to understand the population of older metastatic breast cancer&#xD;
           patients seen in routine practice at community centers, and assess their treatment&#xD;
           approach.&#xD;
&#xD;
        2. Educational programming about management of older metastatic breast cancer patients, and&#xD;
           geriatric assessment of these patients.&#xD;
&#xD;
        3. Active testing of the use of geriatric assessment in clinical practice.&#xD;
&#xD;
      The ultimate goal is to develop an educational curriculum that could be implemented at other&#xD;
      community oncology sites beyond the participants on this study. This type of educational&#xD;
      intervention can be applied to other disease sites in the future. During the study period we&#xD;
      will identify the specific gaps that exist in each practice and develop an educational&#xD;
      intervention to match these gaps. Our hope is that all involved practices will benefit from&#xD;
      incorporating a geriatric assessment into their practice and will find it feasible to use the&#xD;
      tools provided. These data are of high importance to the oncologic community and would be&#xD;
      hypothesis-generating for future clinical trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">April 23, 2019</completion_date>
  <primary_completion_date type="Actual">April 23, 2019</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of geriatric abnormalities detected</measure>
    <time_frame>18 months</time_frame>
    <description>Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of treatment plan changes</measure>
    <time_frame>18 months</time_frame>
    <description>Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider perception</measure>
    <time_frame>18 months</time_frame>
    <description>Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Provider Didactic Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1 - Providers complete a needs assessment questionnaire.&#xD;
Phase 2 - Providers participate in an hour long didactic session, and begin enrolling eligible metastatic breast cancer (MBC) patients. Enrolled MBC patients complete a comprehensive geriatric assessment (CGA). Providers complete a treatment plan questionnaire and a CGA utility questionnaire.&#xD;
Phase 3 - Providers are administered a final questionnaire evaluating their overall view of this educational intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Didactic session</intervention_name>
    <description>This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.</description>
    <arm_group_label>Provider Didactic Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Geriatric Assessment</intervention_name>
    <description>The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.</description>
    <arm_group_label>Provider Didactic Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of metastatic breast cancer (MBC)&#xD;
&#xD;
          -  Ongoing active therapy for MBC&#xD;
&#xD;
          -  Ability to sign informed consent, and complete a self-assessment evaluation.&#xD;
&#xD;
          -  Life expectancy &gt;3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No evidence of MBC&#xD;
&#xD;
          -  Inability to read and understand English&#xD;
&#xD;
          -  Not on active therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AtlantiCare Cancer Care Institute</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pottstown Memorial Medical Center</name>
      <address>
        <city>Pottstown</city>
        <state>Pennsylvania</state>
        <zip>19464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Confluence Health</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2020</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>
  <!-- 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/NCT03007641
org study id: 16-8003
nct id: NCT03007641
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to enhance the care of older metastatic breast cancer (MBC)
      patients by increasing awareness among oncology providers as to the unique aspects of care
      required for older patients. The goal of the study is to educate providers on the utility of
      geriatric assessment in guiding therapy of older metastatic breast cancer patients. The
      investigators will also assess the feasibility and benefit of incorporating geriatric
      self-assessments into clinical practice. The study will include three phases.
Older oncology patients pose a significant treatment challenge due to poor chemotherapy
      tolerance as a result of underlying co-morbidities, lack of social support, and diminished
      functional reserve. Oncologists are faced with the challenge of differentiating between
      patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's
      biologic rather than chronologic age.

      A significant challenge that surrounds the treatment of the older metastatic breast cancer
      (MBC) patient in particular, lies in the lack of evidence based clinical data to guide the
      oncologist in determination of a treatment plan. This is a result of under representation of
      older patients in clinical trials. Due to these challenges a thorough evaluation of the older
      patient is recommended prior to initiation of anti-cancer therapy.

      The purpose of this research study is to enhance the care of the older MBC patient by
      increasing awareness among oncology providers as to the unique aspects of care required for
      older patients. The goal of the study is to educate providers on the utility of geriatric
      assessment in guiding therapy of older metastatic breast cancer patients. The investigators
      will also assess the feasibility and benefit of incorporating geriatric self-assessments into
      clinical practice. The study will include three phases:

        1. Needs assessments - to understand the population of older metastatic breast cancer
           patients seen in routine practice at community centers, and assess their treatment
           approach.

        2. Educational programming about management of older metastatic breast cancer patients, and
           geriatric assessment of these patients.

        3. Active testing of the use of geriatric assessment in clinical practice.

      The ultimate goal is to develop an educational curriculum that could be implemented at other
      community oncology sites beyond the participants on this study. This type of educational
      intervention can be applied to other disease sites in the future. During the study period we
      will identify the specific gaps that exist in each practice and develop an educational
      intervention to match these gaps. Our hope is that all involved practices will benefit from
      incorporating a geriatric assessment into their practice and will find it feasible to use the
      tools provided. These data are of high importance to the oncologic community and would be
      hypothesis-generating for future clinical trials.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of geriatric abnormalities detected
time frame: 18 months
description: Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.
measure: Percentage of treatment plan changes
time frame: 18 months
description: Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
measure: Provider perception
time frame: 18 months
description: Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.
arm group label: Provider Didactic Intervention
arm group type: Experimental
description: Phase 1 - Providers complete a needs assessment questionnaire.
Phase 2 - Providers participate in an hour long didactic session, and begin enrolling eligible metastatic breast cancer (MBC) patients. Enrolled MBC patients complete a comprehensive geriatric assessment (CGA). Providers complete a treatment plan questionnaire and a CGA utility questionnaire.
Phase 3 - Providers are administered a final questionnaire evaluating their overall view of this educational intervention.
intervention type: Behavioral
intervention name: Didactic session
description: This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.
arm group label: Provider Didactic Intervention
intervention type: Behavioral
intervention name: Comprehensive Geriatric Assessment
description: The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.
arm group label: Provider Didactic Intervention
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms