Bnai Zion Medical Center
Haifa, 3339419, Israel
Location status: Recruiting
NCT Number: NCT05982262
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Haifa, 3339419, Israel
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None
The naturopathic-pharmacological consultation includes a naturopath and a clinical pharmacist and will consist of at least two meetings.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Interested in participating?
Request InfoBnai Zion Medical Center
Other Gov
Naturopathic-pharmacological Consultation on the Use of Dietary Supplements in Patients With Hematological Diseases
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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