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NCT Number: NCT05982262

Naturopathic-pharmacological Consultation in Hematology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location status: Recruiting

Location contact

Elad Schiff, MD

SUB_INVESTIGATOR

Ilana Levy Yurkovski, MD

PRINCIPAL_INVESTIGATOR

Miriam Goldberg

CONTACT

[email protected]

972-48359351

Ohad Cohen Naznin

SUB_INVESTIGATOR

Samuel Attias, PhD

SUB_INVESTIGATOR

Tamar Tadmor, MD

SUB_INVESTIGATOR

Yael Gross Geva

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Followed up for a hematological condition
  • Ability to fill simple questionnaires in Hebrew, Russian or Arabic
  • Indication for consultation:
  • Patient's request to expand knowledge about the use of DHS
  • Patient using DHS
  • Patient's desire to start using DHS
  • Patient that is interested in hearing about the use of DHS for his/her health condition
  • Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.

Exclusion criteria

None

Treatment and study plan

Naturopathic-pharmacological consultation

Other

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

Primary outcomes

  1. Safety of the use of DHS in patients with a hematological disease through naturopathic counseling

    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.

Secondary outcomes

  1. Efficacy of prescribed dietary and herbal supplements (DHS)

    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.

  2. Patient-physician communication around the use of DHS

    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

  3. Patient satisfaction

    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)

  4. Compliance with hematological treatment

    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

  5. Qualitative evaluation of the staff and patients from naturopathic-pharmacological counseling

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Weizer

CONTACT

[email protected]

972543295952

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 8, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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