Naturopathic-pharmacological Consultation in Hematology

Not Applicable

Recruiting

• Conditions: Hematologic Diseases
• Interventions: Other: Naturopathic-pharmacological consultation

• Registration Number: NCT05982262
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-30
• Study First Posted: 2023-08-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with hematological conditions	Naturopathic-pharmacological consultation	Patients will be referred by the medical or nursing staff of the Hematology Unit at the Bnai Zion Medical Center according to inclusion criteria

Primary Outcome Measures

Name	Time	Method
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 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

Name	Time	Method
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.
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
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)
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
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

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel