Naturopathic-pharmacological Consultation in Hematology

Hematologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982262
• Other study ID #: 0149-20-BNZ
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Bnai Zion Medical Center
• Contact: Dana Weizer
• Phone: 972543295952
• Email: dana.weizer[@]b-zion.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Other:
• Naturopathic-pharmacological consultation
The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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