xml: <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/NCT05971056</url>
    </required_header>
    <id_info>
      <org_study_id>202306162</org_study_id>
      <nct_id>NCT05971056</nct_id>
    </id_info>
    <brief_title>Providing Cancer Care Closer to Home for Patients With Multiple Myeloma</brief_title>
    <official_title>A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Washington University School of Medicine</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>
        There is very limited data on the utilization of National Cancer Institute Comprehensive&#xD;
        Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards&#xD;
        to providing chemotherapy at facilities closer to patients' home. These &quot;satellite&#xD;
        chemotherapy infusion centers&quot;, typically community-based treatment locations at community&#xD;
        hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by&#xD;
        patients who utilize their services and reduce their travel times and expenses. In these&#xD;
        studies patients still remained in the care of their current provider and site and are&#xD;
        required to travel to the site for clinical visits and other appointments. It is currently&#xD;
        unknown if patients are willing to transfer their care to a different provider to alleviate&#xD;
        travel burden. In addition, although increased travel burden has been lower quality of life&#xD;
        in cross-sectional studies, no data exists suggesting that these reducing travel burden can&#xD;
        improve these outcomes intra-patient, to the knowledge of the investigators.&#xD;
  &#xD;
        The patient roles of the multiple myeloma clinical providers at the Siteman primary location&#xD;
        have grown in recent years. The providers have determined a need to refer some patients to&#xD;
        the satellite sites to relieve congestion at the site while also hopefully improving the&#xD;
        clinical experience for those patients. This study is a natural experiment of this process.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of eligible participants who successfully transfer to the provider at a satellite location</measure>
      <time_frame>At time of transfer decision (day 1)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Types of candidacy that providers use for transfer of care to satellite sites</measure>
      <time_frame>At time of transfer decision (day 1)</time_frame>
      <description>Qualitative data collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire</measure>
      <time_frame>Through completion of follow-up (estimated to be 6 months)</time_frame>
      <description>Explore differences in participant experience between those that elect to transfer to a satellite site and those who decline to transfer.&#xD;
  The Modified Treatment Burden Questionnaire will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 3 questions with answers ranging from 0 (not a problem) to 10 (big problem). The higher the score the more treatment burden the participant experienced.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction</measure>
      <time_frame>Through completion of follow-up (estimated to be 6 months)</time_frame>
      <description>Explore differences in participant satisfaction between those that elect to transfer to a satellite site and those who decline to transfer.&#xD;
  The Questionnaire on the Quality of Physician-Patient Interaction will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 14 questions with answers ranging from 1 (do not agree) to 5 (I fully agree). The higher the score the higher the quality of the physician-patient interactions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity</measure>
      <time_frame>Through completion of follow-up (estimated to be 6 months)</time_frame>
      <description>Explore differences in participant financial toxicity between those that elect to transfer to a satellite site and those who decline to transfer.&#xD;
  The Comprehensive Score for Financial Toxicity will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 11 questions with answers ranging from 0 (not at all) to 4 (very much). The higher the score the less financial toxicity the participant experienced.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Care transition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No care transition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Care transition</intervention_name>
      <description>Cancer care is transitioned to a satellite site.</description>
      <arm_group_label>Care transition</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No care transition</intervention_name>
      <description>Cancer care is not transitioned to a satellite site.</description>
      <arm_group_label>No care transition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Eligibility Criteria&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Diagnosed with multiple myeloma&#xD;
  &#xD;
            -  Receiving care from a provider within the Division of Oncology at the primary Siteman&#xD;
               Cancer Center site&#xD;
  &#xD;
            -  Resides within the catchment area of a Siteman Cancer Center satellite site&#xD;
  &#xD;
            -  Able to read, speak, and understand English&#xD;
  &#xD;
            -  Willing to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Fiala, Ph.D., MSW</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mark Fiala, Ph.D. MSW</last_name>
      <phone>314-273-2783</phone>
      <email>mfiala@wustl.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mark Fiala, Ph.D., MSW</last_name>
        <phone>314-273-2783</phone>
        <email>mfiala@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Mark Fiala, Ph.D., MSW</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.siteman.wustl.edu</url>
      <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>access to care</keyword>
    <keyword>travel burden</keyword>
    <keyword>financial toxicity</keyword>
    <keyword>patient satisfaction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971056
  org study id: 202306162
  nct id: NCT05971056
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is very limited data on the utilization of National Cancer Institute Comprehensive
        Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards
        to providing chemotherapy at facilities closer to patients' home. These "satellite
        chemotherapy infusion centers", typically community-based treatment locations at community
        hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by
        patients who utilize their services and reduce their travel times and expenses. In these
        studies patients still remained in the care of their current provider and site and are
        required to travel to the site for clinical visits and other appointments. It is currently
        unknown if patients are willing to transfer their care to a different provider to alleviate
        travel burden. In addition, although increased travel burden has been lower quality of life
        in cross-sectional studies, no data exists suggesting that these reducing travel burden can
        improve these outcomes intra-patient, to the knowledge of the investigators.
  
        The patient roles of the multiple myeloma clinical providers at the Siteman primary location
        have grown in recent years. The providers have determined a need to refer some patients to
        the satellite sites to relieve congestion at the site while also hopefully improving the
        clinical experience for those patients. This study is a natural experiment of this process.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Proportion of eligible participants who successfully transfer to the provider at a satellite location
  time frame: At time of transfer decision (day 1)
  measure: Types of candidacy that providers use for transfer of care to satellite sites
  time frame: At time of transfer decision (day 1)
  description: Qualitative data collection
  measure: Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire
  time frame: Through completion of follow-up (estimated to be 6 months)
  description: Explore differences in participant experience between those that elect to transfer to a satellite site and those who decline to transfer.
  The Modified Treatment Burden Questionnaire will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 3 questions with answers ranging from 0 (not a problem) to 10 (big problem). The higher the score the more treatment burden the participant experienced.
  measure: Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction
  time frame: Through completion of follow-up (estimated to be 6 months)
  description: Explore differences in participant satisfaction between those that elect to transfer to a satellite site and those who decline to transfer.
  The Questionnaire on the Quality of Physician-Patient Interaction will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 14 questions with answers ranging from 1 (do not agree) to 5 (I fully agree). The higher the score the higher the quality of the physician-patient interactions.
  measure: Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity
  time frame: Through completion of follow-up (estimated to be 6 months)
  description: Explore differences in participant financial toxicity between those that elect to transfer to a satellite site and those who decline to transfer.
  The Comprehensive Score for Financial Toxicity will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 11 questions with answers ranging from 0 (not at all) to 4 (very much). The higher the score the less financial toxicity the participant experienced.
  arm group label: Care transition
  arm group type: Experimental
  description: -At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
  arm group label: No care transition
  arm group type: Active Comparator
  description: -At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
  intervention type: Other
  intervention name: Care transition
  description: Cancer care is transitioned to a satellite site.
  arm group label: Care transition
  intervention type: Other
  intervention name: No care transition
  description: Cancer care is not transitioned to a satellite site.
  arm group label: No care transition
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mark Fiala, Ph.D., MSW
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Mark Fiala, Ph.D. MSW
  phone: 314-273-2783
  email: mfiala@wustl.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://www.siteman.wustl.edu
  description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No