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/NCT05965206</url>
    </required_header>
    <id_info>
      <org_study_id>Study00002683</org_study_id>
      <nct_id>NCT05965206</nct_id>
    </id_info>
    <brief_title>Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic</brief_title>
    <official_title>Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cedars-Sinai Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cedars-Sinai Medical Center</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>
        The purpose of this study is to determine the impact of pharmacists on reducing&#xD;
        chemotherapy-related side effects by providing education before and after patients receive&#xD;
        intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers.&#xD;
  &#xD;
        Participants will be interviewed via telephone within 7 business days after receiving&#xD;
        intravenous chemotherapy from the outpatient cancer center infusion clinic.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study involves participation at a single timepoint only.&#xD;
  &#xD;
        Participants who consented to participate and are considered eligible will be interviewed by&#xD;
        a pharmacist via phone at approximately 7 business days after receiving intravenous&#xD;
        chemotherapy infusion. Phone call will be made between the hours of 9am - 6pm on Monday -&#xD;
        Saturday. Calls are anticipated to last between 15 to 20 minutes. Participants will be asked&#xD;
        if they have experienced any adverse events since the infusion, whether or not they have had&#xD;
        any barriers taking supportive care medications, and if the patient understands how to manage&#xD;
        potential adverse events. If applicable, participants will be provided further education on&#xD;
        optimizing adverse events, guided on proper medication administration times, and will be&#xD;
        provided with non-pharmacological clinical pearls to minimize chemotherapy-related side&#xD;
        effects and optimize supportive care management.&#xD;
  &#xD;
        If unable to reach the participant or caregiver after three attempts, the participant will be&#xD;
        considered ineligible. Participants can decline participation at any time during the phone&#xD;
        call.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Hospital admission related to chemotherapy within 30-day post treatment</measure>
      <time_frame>30 days after receiving the first intravenous chemotherapy</time_frame>
      <description>Number of hospital admission related to chemotherapy</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <description>Participants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Follow-up phone interview</intervention_name>
      <description>Follow-up phone interview within 7 business days after receiving intravenous chemotherapy</description>
      <arm_group_label>Intervention group</arm_group_label>
      <other_name>Follow-up call</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult cancer patients who initiated treatment with intravenous chemotherapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Diagnosed with cancer and is receiving treatment with intravenous chemotherapy&#xD;
  &#xD;
            -  Treatment initiated at Cedars-Sinai Cancer Samuel Oschin Cancer Center (SOCC) or&#xD;
               Cedars-Sinai Cancer Beverly Hills (CSCBH)&#xD;
  &#xD;
            -  English-speaking or lives with English-speaking person&#xD;
  &#xD;
            -  Access to a working phone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received follow-up calls through other specialty pharmacy program&#xD;
  &#xD;
            -  History of infusion related reactions&#xD;
  &#xD;
            -  Declined participation on follow-up interview&#xD;
  &#xD;
            -  Age less than 18 years old&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Electronic health record flagged for research opt out&#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>Suwicha Limvorasak, PharmD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cedars-Sinai Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suwicha Limvorasak, PharmD</last_name>
      <phone>310-423-0634</phone>
      <email>suwicha.limvorasak@cshs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jennie Kittipha, PharmD</last_name>
      <phone>310-423-0633</phone>
      <email>jennie.kittipha@cshs.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cedars-Sinai Medical Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90048</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Suwicha Limvorasak, PharmD</last_name>
        <phone>310-423-0634</phone>
        <email>suwicha.limvorasak@cshs.org</email>
      </contact>
      <investigator>
        <last_name>Jennie Kittipha, PharmD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Patel SD, Nguyen PAA, Bachler M, Atkinson B. Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. Am J Health Syst Pharm. 2017 Jun 1;74(11 Supplement 2):S42-S46. doi: 10.2146/ajhp160805.</citation>
      <PMID>28506976</PMID>
    </reference>
    <reference>
      <citation>Nguyen PAA, Enwere E, Gautreaux S, Lin H, Tverdek F, Lu M, Cao H, Chase J, Roux R. Impact of a pharmacy-driven transitions-of-care program on postdischarge healthcare utilization at a national comprehensive cancer center. Am J Health Syst Pharm. 2018 Sep 15;75(18):1386-1393. doi: 10.2146/ajhp170747. Epub 2018 Jul 31.</citation>
      <PMID>30065061</PMID>
    </reference>
    <results_reference>
      <citation>Cebollero J, LaFollette JA, Walton SM, Adams Curry M. Evaluation of a Pharmacist-Developed, Nurse-Driven Protocol for Management of Parenteral Anticancer Therapy Infusion Reactions in an Ambulatory Infusion Center. J Oncol Pharm Pract. 2023 Jun;29(4):802-809. doi: 10.1177/10781552221079855. Epub 2022 Feb 14.</citation>
      <PMID>35164607</PMID>
    </results_reference>
    <results_reference>
      <citation>Crannage AJ, Hennessey EK, Challen LM, Stevens AM, Berry TM. Implementation of a Discharge Education Program to Improve Transitions of Care for Patients at High Risk of Medication Errors. Ann Pharmacother. 2020 Jun;54(6):561-566. doi: 10.1177/1060028019896377. Epub 2019 Dec 21.</citation>
      <PMID>31868004</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Suwicha Limvorasak</investigator_full_name>
      <investigator_title>PharmD</investigator_title>
    </responsible_party>
    <keyword>Pharmacist</keyword>
    <keyword>Follow up clinic</keyword>
    <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/NCT05965206
  org study id: Study00002683
  nct id: NCT05965206
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine the impact of pharmacists on reducing
        chemotherapy-related side effects by providing education before and after patients receive
        intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers.
  
        Participants will be interviewed via telephone within 7 business days after receiving
        intravenous chemotherapy from the outpatient cancer center infusion clinic.
  The study involves participation at a single timepoint only.
  
        Participants who consented to participate and are considered eligible will be interviewed by
        a pharmacist via phone at approximately 7 business days after receiving intravenous
        chemotherapy infusion. Phone call will be made between the hours of 9am - 6pm on Monday -
        Saturday. Calls are anticipated to last between 15 to 20 minutes. Participants will be asked
        if they have experienced any adverse events since the infusion, whether or not they have had
        any barriers taking supportive care medications, and if the patient understands how to manage
        potential adverse events. If applicable, participants will be provided further education on
        optimizing adverse events, guided on proper medication administration times, and will be
        provided with non-pharmacological clinical pearls to minimize chemotherapy-related side
        effects and optimize supportive care management.
  
        If unable to reach the participant or caregiver after three attempts, the participant will be
        considered ineligible. Participants can decline participation at any time during the phone
        call.
  observational model: Cohort
  time perspective: Prospective
  measure: Hospital admission related to chemotherapy within 30-day post treatment
  time frame: 30 days after receiving the first intravenous chemotherapy
  description: Number of hospital admission related to chemotherapy
  arm group label: Intervention group
  description: Participants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion
  arm group label: Control group
  description: Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion
  intervention type: Behavioral
  intervention name: Follow-up phone interview
  description: Follow-up phone interview within 7 business days after receiving intravenous chemotherapy
  arm group label: Intervention group
  other name: Follow-up call
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Suwicha Limvorasak, PharmD
  role: Principal Investigator
  affiliation: Cedars-Sinai Medical Center
  last name: Suwicha Limvorasak, PharmD
  phone: 310-423-0634
  email: suwicha.limvorasak@cshs.org
  last name: Jennie Kittipha, PharmD
  phone: 310-423-0633
  email: jennie.kittipha@cshs.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  citation: Patel SD, Nguyen PAA, Bachler M, Atkinson B. Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. Am J Health Syst Pharm. 2017 Jun 1;74(11 Supplement 2):S42-S46. doi: 10.2146/ajhp160805.
  PMID: 28506976
  citation: Nguyen PAA, Enwere E, Gautreaux S, Lin H, Tverdek F, Lu M, Cao H, Chase J, Roux R. Impact of a pharmacy-driven transitions-of-care program on postdischarge healthcare utilization at a national comprehensive cancer center. Am J Health Syst Pharm. 2018 Sep 15;75(18):1386-1393. doi: 10.2146/ajhp170747. Epub 2018 Jul 31.
  PMID: 30065061
  citation: Cebollero J, LaFollette JA, Walton SM, Adams Curry M. Evaluation of a Pharmacist-Developed, Nurse-Driven Protocol for Management of Parenteral Anticancer Therapy Infusion Reactions in an Ambulatory Infusion Center. J Oncol Pharm Pract. 2023 Jun;29(4):802-809. doi: 10.1177/10781552221079855. Epub 2022 Feb 14.
  PMID: 35164607
  citation: Crannage AJ, Hennessey EK, Challen LM, Stevens AM, Berry TM. Implementation of a Discharge Education Program to Improve Transitions of Care for Patients at High Risk of Medication Errors. Ann Pharmacother. 2020 Jun;54(6):561-566. doi: 10.1177/1060028019896377. Epub 2019 Dec 21.
  PMID: 31868004
  responsible party type: Principal Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Suwicha Limvorasak
  investigator title: PharmD
  sharing ipd: No