Naturopathic-pharmacological Consultation in Hematology
ConditionHematologic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBnai Zion Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Followed up for a hematological condition
Ability to fill simple questionnaires in Hebrew, Russian or Arabic
Patient's request to expand knowledge about the use of DHS
Patient using DHS
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Naturopathic-pharmacological consultation
Other interventionThe naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients with hematological conditionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of intervention, up to 1 yearSecondary outcomes
1
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.
Time frame
From enrollment to the end of intervention, up to 1 year2
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
Time frame
From enrollment to the end of intervention, up to 1 year3
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)
Time frame
From enrollment to the end of intervention, up to 1 year4
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
Time frame
From enrollment to the end of intervention, up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov