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Naturopathic-pharmacological Consultation in Hematology

Primary Purpose

Hematologic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Naturopathic-pharmacological consultation
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematologic Diseases focused on measuring Dietary supplements, Herbal supplements, Hematology, Safety, Consultation, Naturopath, Clinical pharmacist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Followed up for a hematological condition Ability to fill simple questionnaires in Hebrew, Russian or Arabic Indication for consultation: Patient's request to expand knowledge about the use of DHS Patient using DHS Patient's desire to start using DHS Patient that is interested in hearing about the use of DHS for his/her health condition Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment. Exclusion Criteria: None

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with hematological conditions

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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)
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
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

Full Information

First Posted
July 16, 2023
Last Updated
October 9, 2023
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05982262
Brief Title
Naturopathic-pharmacological Consultation in Hematology
Official Title
Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
Dietary supplements, Herbal supplements, Hematology, Safety, Consultation, Naturopath, Clinical pharmacist

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with hematological conditions
Arm Type
Experimental
Arm 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(s)
Naturopathic-pharmacological consultation
Intervention Description
The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.
Primary Outcome Measure Information:
Title
Safety of the use of DHS in patients with a hematological disease through naturopathic counseling
Description
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.
Time Frame
From enrollment to the end of intervention, up to 1 year
Secondary Outcome Measure Information:
Title
Efficacy of prescribed dietary and herbal supplements (DHS)
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.
Time Frame
From enrollment to the end of intervention, up to 1 year
Title
Patient-physician communication around the use of DHS
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
Time Frame
From enrollment to the end of intervention, up to 1 year
Title
Patient satisfaction
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)
Time Frame
From enrollment to the end of intervention, up to 1 year
Title
Compliance with hematological treatment
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
Time Frame
From enrollment to the end of intervention, up to 1 year
Title
Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling
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
Time Frame
From enrollment to the end of intervention, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Followed up for a hematological condition Ability to fill simple questionnaires in Hebrew, Russian or Arabic Indication for consultation: Patient's request to expand knowledge about the use of DHS Patient using DHS Patient's desire to start using DHS Patient that is interested in hearing about the use of DHS for his/her health condition Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment. Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Weizer
Phone
972543295952
Email
dana.weizer@b-zion.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Levy Yurkovski, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Goldberg
Phone
972-48359351
Email
miriam.goldberg@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Ilana Levy Yurkovski, MD
First Name & Middle Initial & Last Name & Degree
Ohad Cohen Naznin
First Name & Middle Initial & Last Name & Degree
Yael Gross Geva
First Name & Middle Initial & Last Name & Degree
Tamar Tadmor, MD
First Name & Middle Initial & Last Name & Degree
Elad Schiff, MD
First Name & Middle Initial & Last Name & Degree
Samuel Attias, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Naturopathic-pharmacological Consultation in Hematology

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