Naturopathic-pharmacological Consultation in Hematology

Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Diseases
• Intervention / Treatment: Other: Naturopathic-pharmacological consultation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Weizer; Phone Number: 972543295952; Email: dana.weizer@b-zion.org.il

Study Locations

• Israel
  • Haifa, Israel, 3339419
    • Recruiting
    • Bnai Zion Medical Center
    • Contact: Miriam Goldberg; Phone Number: 972-48359351; Email: miriam.goldberg@b-zion.org.il
    • Principal Investigator: Ilana Levy Yurkovski, MD
    • Sub-Investigator: Ohad Cohen Naznin
    • Sub-Investigator: Yael Gross Geva
    • Sub-Investigator: Tamar Tadmor, MD
    • Sub-Investigator: Elad Schiff, MD
    • Sub-Investigator: Samuel Attias, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Followed up for a hematological condition
2. Ability to fill simple questionnaires in Hebrew, Russian or Arabic

3. Indication for consultation:

   1. Patient's request to expand knowledge about the use of DHS
   2. Patient using DHS
   3. Patient's desire to start using DHS
   4. Patient that is interested in hearing about the use of DHS for his/her health condition
   5. Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with hematological conditions; Patients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria	Other: Naturopathic-pharmacological consultation; The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the use of DHS in patients with a hematological disease through naturopathic counseling	Number of potential interactions with moderate to major level of significance prevented by the naturopathic consultation in each patient, as well as the incidence of DHS-related safety events. The Naranjo and modified Food and Drug Administration algorithm will be used to assess the causality of such events with the specific dietary supplements, and only side effects at least possibly caused by the DHS according to these scales will be considered.	From enrollment to the end of intervention, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of prescribed dietary and herbal supplements (DHS)	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.	From enrollment to the end of intervention, up to 1 year
Patient-physician communication around the use of DHS	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	From enrollment to the end of intervention, up to 1 year
Patient satisfaction	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)	From enrollment to the end of intervention, up to 1 year
Compliance with hematological treatment	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	From enrollment to the end of intervention, up to 1 year
Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling	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	From enrollment to the end of intervention, up to 1 year

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Hematology; Clinical pharmacist; Dietary supplements; Consultation; Herbal supplements; Naturopath
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 0149-20-BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No