Naturopathic-pharmacological Consultation in Hematology

Sponsor
Bnai Zion Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05982262
Collaborator
(none)
100
1
1
59.6
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Naturopathic-pharmacological consultation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
Actual Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Safety of the use of DHS in patients with a hematological disease through naturopathic counseling [From enrollment to the end of intervention, up to 1 year]

    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%.

Secondary Outcome Measures

  1. Efficacy of prescribed dietary and herbal supplements (DHS) [From enrollment to the end of intervention, up to 1 year]

    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.

  2. Patient-physician communication around the use of DHS [From enrollment to the end of intervention, up to 1 year]

    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

  3. Patient satisfaction [From enrollment to the end of intervention, up to 1 year]

    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)

  4. Compliance with hematological treatment [From enrollment to the end of intervention, up to 1 year]

    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

  5. Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling [From enrollment to the end of intervention, up to 1 year]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Followed up for a hematological condition

  2. Ability to fill simple questionnaires in Hebrew, Russian or Arabic

  3. Indication for consultation:

  4. Patient's request to expand knowledge about the use of DHS

  5. Patient using DHS

  6. Patient's desire to start using DHS

  7. Patient that is interested in hearing about the use of DHS for his/her health condition

  8. Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.

Exclusion Criteria:

None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bnai Zion Medical Center Haifa Israel 3339419

Sponsors and Collaborators

  • Bnai Zion Medical Center

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT05982262
Other Study ID Numbers:
  • 0149-20-BNZ
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bnai Zion Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2023