<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/NCT03257917</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-170504005</org_study_id>
    <nct_id>NCT03257917</nct_id>
  </id_info>
  <brief_title>Understanding Value in Metastatic Breast Cancer</brief_title>
  <official_title>Understanding Out-of-pocket Expenses and Patient Time Spent on Healthcare in Metastatic Breast Cancer Patients (Understanding Value in Metastatic Breast Cancer)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses&#xD;
      and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this&#xD;
      objective, MBC patients will be asked to participate in a short, 37-question survey asking&#xD;
      questions about the financial burden, OOP expenses, and opportunity costs related to their&#xD;
      cancer care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treating physician, PI or study coordinator will inform eligible MBC patients about the&#xD;
      study via a letter (Appendix B) during or prior to their regular clinic visits in a waiting&#xD;
      area. Prior to the survey administration, study coordinator will obtain all necessary&#xD;
      signatures on the ICF from interested study participants in the private clinic room or&#xD;
      infusion area. The survey (Appendix A) will consist of 37 survey questions, which should take&#xD;
      patients less than 30 minutes to complete during their regularly scheduled clinic visit.&#xD;
      Study participants will have the option of taking incomplete surveys home, completing, and&#xD;
      mailing it back to us using stamped, self-addressed envelopes provided during their clinic&#xD;
      visit. All consented participants will also be given the option to complete the survey over&#xD;
      the phone with a study coordinator. Participants will be requested to provide their&#xD;
      preferable times and days for a phone call with a coordinator. The study coordinator will&#xD;
      call the patient and administer the same survey that would be given during a clinic visit. If&#xD;
      participants prefer completing the survey in the clinic a research coordinator will remain in&#xD;
      the room and will verbally facilitate the completion of the survey. Participants will be&#xD;
      compensated in the form of merchandise at the time they agree to participate (the photo of&#xD;
      sample merchandise is attached). Surveys will be collected by the study coordinator and&#xD;
      stored in secure, locked rooms at the UAB Comprehensive Cancer Center, where the study&#xD;
      coordinators will double-key enter de-identified survey responses into an encrypted, password&#xD;
      protected, electronic database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 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>Post-cancer diagnosis cost</measure>
    <time_frame>2 years</time_frame>
    <description>based on a validated survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time loss experienced by patients with metastatic breast cancer.</measure>
    <time_frame>2 years</time_frame>
    <description>based on a validated survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?</measure>
    <time_frame>2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does treatment type (chemotherapy vs. hormone therapy) influence the total cost of care or financial burden?</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>What is the trajectory of financial burden or total cost of care over time (year pre-MBC diagnosis vs. post-MBC diagnosis)?</measure>
    <time_frame>2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does financial burden or total cost of care influence treatment adherence?</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does clinical trial participation influence the total cost of care or financial burden?</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does financial burden or total cost of care influence perception of or preference for shared decision-making?</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the cost experienced by patients with metastatic breast cancer.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the productivity loss experienced by patients with metastatic breast cancer.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Understanding value in Metastatic Breast Cancer</intervention_name>
    <description>The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants will be derived from Metastatic Breast Cancer patients receiving care at&#xD;
        UAB Kirklin Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All female MBC patients 18 years of age and older who have received treatment within&#xD;
             the past two years at UAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers, patients residing in nursing homes or receiving hospice care&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gabrielle B Rocque, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 22, 2019</last_update_submitted>
  <last_update_submitted_qc>August 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Gabrielle Rocque</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Financial Burden</keyword>
  <keyword>Out of Pocket expenses</keyword>
  <keyword>Time spent on Healthcare</keyword>
  <keyword>Metastatic 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>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/NCT03257917
org study id: IRB-170504005
nct id: NCT03257917
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses
      and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this
      objective, MBC patients will be asked to participate in a short, 37-question survey asking
      questions about the financial burden, OOP expenses, and opportunity costs related to their
      cancer care
The treating physician, PI or study coordinator will inform eligible MBC patients about the
      study via a letter (Appendix B) during or prior to their regular clinic visits in a waiting
      area. Prior to the survey administration, study coordinator will obtain all necessary
      signatures on the ICF from interested study participants in the private clinic room or
      infusion area. The survey (Appendix A) will consist of 37 survey questions, which should take
      patients less than 30 minutes to complete during their regularly scheduled clinic visit.
      Study participants will have the option of taking incomplete surveys home, completing, and
      mailing it back to us using stamped, self-addressed envelopes provided during their clinic
      visit. All consented participants will also be given the option to complete the survey over
      the phone with a study coordinator. Participants will be requested to provide their
      preferable times and days for a phone call with a coordinator. The study coordinator will
      call the patient and administer the same survey that would be given during a clinic visit. If
      participants prefer completing the survey in the clinic a research coordinator will remain in
      the room and will verbally facilitate the completion of the survey. Participants will be
      compensated in the form of merchandise at the time they agree to participate (the photo of
      sample merchandise is attached). Surveys will be collected by the study coordinator and
      stored in secure, locked rooms at the UAB Comprehensive Cancer Center, where the study
      coordinators will double-key enter de-identified survey responses into an encrypted, password
      protected, electronic database.
observational model: Cohort
time perspective: Cross-Sectional
measure: Post-cancer diagnosis cost
time frame: 2 years
description: based on a validated survey
measure: Time loss experienced by patients with metastatic breast cancer.
time frame: 2 years
description: based on a validated survey
measure: Do patient characteristics (sociodemographics, cancer characteristics, health status, healthcare utilization) influence the total cost of care or financial burden?
time frame: 2 Years
measure: Does treatment type (chemotherapy vs. hormone therapy) influence the total cost of care or financial burden?
time frame: 2 years
measure: What is the trajectory of financial burden or total cost of care over time (year pre-MBC diagnosis vs. post-MBC diagnosis)?
time frame: 2 Years
measure: Does financial burden or total cost of care influence treatment adherence?
time frame: 2 years
measure: Does clinical trial participation influence the total cost of care or financial burden?
time frame: 2 years
measure: Does financial burden or total cost of care influence perception of or preference for shared decision-making?
time frame: 2 years
measure: Describe the cost experienced by patients with metastatic breast cancer.
time frame: 2 years
measure: Describe the productivity loss experienced by patients with metastatic breast cancer.
time frame: 2 years
intervention type: Other
intervention name: Understanding value in Metastatic Breast Cancer
description: The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 90 Years
last name: Gabrielle B Rocque, MD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Gabrielle Rocque
investigator title: Assistant Professor
mesh term: Breast Neoplasms
sharing ipd: No