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/NCT05982262</url>
    </required_header>
    <id_info>
      <org_study_id>0149-20-BNZ</org_study_id>
      <nct_id>NCT05982262</nct_id>
    </id_info>
    <brief_title>Naturopathic-pharmacological Consultation in Hematology</brief_title>
    <official_title>Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bnai Zion Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bnai Zion Medical Center</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 goal of this cross-sectional study is to learn about the effect of a&#xD;
        naturopathic-pharmacologic consultation in patients with hematologic conditions. The main&#xD;
        question it aims to answer is whether such consultation can improve the safety of dietary and&#xD;
        herbal supplements' use among these patients.&#xD;
  &#xD;
        Participants will be asked to answer basic questions and fill-out questionnaire before and&#xD;
        after meeting the consultation team. Some patients will be prescribed dietary and herbal&#xD;
        supplements that may help relief some of the symptoms they describe, in a safe way and&#xD;
        without interacting with the drugs they are taking.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">June 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2027</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of the use of DHS in patients with a hematological disease through naturopathic counseling</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Number of potential interactions prevented by the consultation in each patient, as well as the incidence of DHS-related safety events. The Naranjo and adapted Drug Interaction Probability Scales (DIPS) will be used to assess the causality of such events with the specific dietary supplements. Since 2% of hospitalizations have been shown to be caused by DHS-related interactions, the intervention will be judged as safe if the incidence of severe adverse events at least possibly caused by the DHS will be under 2%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of prescribed dietary and herbal supplements (DHS)</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-physician communication around the use of DHS</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Asking the patient whether the topic has been brought up with the treating hematologist and checking the documentation of the use of DHS in the medical charts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Direct question asked after each meeting ranking in a 1-5 Likert scale the satisfaction of the patient from the consultation: from 1 (not satisfied at all) to 5 (maximal satisfaction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance with hematological treatment</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Relative dose intensity (RDI) of the prescribed hematological drugs both before and after intervention: The term of dose intensity (DI) is used to define the drug dose delivered per time unit and is expressed as mg/m2 per week. A delay in the sequence of treatment cycles decreases the DI in the same proportion as a reduction of dose. Average relative DI corresponds to the mean DI of combined agents and is expressed as a fraction of a similar combination selected as a standard</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling</measure>
      <time_frame>From enrollment to the end of intervention, up to 1 year</time_frame>
      <description>Semi-structured in-depth interviews will be conducted with patients who are interested in participating in the qualitative arm (10-15 patients) and the staff members involved (medical staff, nursing staff, naturopath, clinical pharmacist). The goal is to describe the process of building the naturopathic-pharmacological consultation and evaluate the satisfaction of the staff and patients</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hematologic Diseases</condition>
    <arm_group>
      <arm_group_label>Patients with hematological conditions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Naturopathic-pharmacological consultation</intervention_name>
      <description>The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.</description>
      <arm_group_label>Patients with hematological conditions</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Followed up for a hematological condition&#xD;
  &#xD;
            2. Ability to fill simple questionnaires in Hebrew, Russian or Arabic&#xD;
  &#xD;
            3. Indication for consultation:&#xD;
  &#xD;
                 1. Patient's request to expand knowledge about the use of DHS&#xD;
  &#xD;
                 2. Patient using DHS&#xD;
  &#xD;
                 3. Patient's desire to start using DHS&#xD;
  &#xD;
                 4. Patient that is interested in hearing about the use of DHS for his/her health&#xD;
                    condition&#xD;
  &#xD;
                 5. Medical or nursing team's recommendation to take DHS for medical treatment or to&#xD;
                    improve compliance with conventional treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#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>Ilana Levy Yurkovski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bnai Zion Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dana Weizer</last_name>
      <phone>972543295952</phone>
      <email>dana.weizer@b-zion.org.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bnai Zion Medical Center</name>
        <address>
          <city>Haifa</city>
          <zip>3339419</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miriam Goldberg</last_name>
        <phone>972-48359351</phone>
        <email>miriam.goldberg@b-zion.org.il</email>
      </contact>
      <investigator>
        <last_name>Ilana Levy Yurkovski, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ohad Cohen Naznin</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yael Gross Geva</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tamar Tadmor, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Elad Schiff, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Samuel Attias, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dietary supplements</keyword>
    <keyword>Herbal supplements</keyword>
    <keyword>Hematology</keyword>
    <keyword>Safety</keyword>
    <keyword>Consultation</keyword>
    <keyword>Naturopath</keyword>
    <keyword>Clinical pharmacist</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hematologic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 5, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT05982262/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05982262
  org study id: 0149-20-BNZ
  nct id: NCT05982262
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this cross-sectional study is to learn about the effect of a
        naturopathic-pharmacologic consultation in patients with hematologic conditions. The main
        question it aims to answer is whether such consultation can improve the safety of dietary and
        herbal supplements' use among these patients.
  
        Participants will be asked to answer basic questions and fill-out questionnaire before and
        after meeting the consultation team. Some patients will be prescribed dietary and herbal
        supplements that may help relief some of the symptoms they describe, in a safe way and
        without interacting with the drugs they are taking.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Safety of the use of DHS in patients with a hematological disease through naturopathic counseling
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Number of potential interactions prevented by the consultation in each patient, as well as the incidence of DHS-related safety events. The Naranjo and adapted Drug Interaction Probability Scales (DIPS) will be used to assess the causality of such events with the specific dietary supplements. Since 2% of hospitalizations have been shown to be caused by DHS-related interactions, the intervention will be judged as safe if the incidence of severe adverse events at least possibly caused by the DHS will be under 2%.
  measure: Efficacy of prescribed dietary and herbal supplements (DHS)
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing.
  measure: Patient-physician communication around the use of DHS
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Asking the patient whether the topic has been brought up with the treating hematologist and checking the documentation of the use of DHS in the medical charts
  measure: Patient satisfaction
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Direct question asked after each meeting ranking in a 1-5 Likert scale the satisfaction of the patient from the consultation: from 1 (not satisfied at all) to 5 (maximal satisfaction)
  measure: Compliance with hematological treatment
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Relative dose intensity (RDI) of the prescribed hematological drugs both before and after intervention: The term of dose intensity (DI) is used to define the drug dose delivered per time unit and is expressed as mg/m2 per week. A delay in the sequence of treatment cycles decreases the DI in the same proportion as a reduction of dose. Average relative DI corresponds to the mean DI of combined agents and is expressed as a fraction of a similar combination selected as a standard
  measure: Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling
  time frame: From enrollment to the end of intervention, up to 1 year
  description: Semi-structured in-depth interviews will be conducted with patients who are interested in participating in the qualitative arm (10-15 patients) and the staff members involved (medical staff, nursing staff, naturopath, clinical pharmacist). The goal is to describe the process of building the naturopathic-pharmacological consultation and evaluate the satisfaction of the staff and patients
  arm group label: Patients with hematological conditions
  arm group type: Experimental
  description: Patients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria
  intervention type: Other
  intervention name: Naturopathic-pharmacological consultation
  description: The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.
  arm group label: Patients with hematological conditions
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ilana Levy Yurkovski, MD
  role: Principal Investigator
  affiliation: Bnai Zion Medical Center
  last name: Dana Weizer
  phone: 972543295952
  email: dana.weizer@b-zion.org.il
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Hematologic Diseases
  sharing ipd: No
  provided document: 