Evaluating the Impact of an Integrative Oncology Training Program for Healthcare Providers

September 12, 2024 updated by: Eran Ben-Arye, Carmel Medical Center

Evaluating the Impact of an Integrative Oncology Training Program for Physicians, Nurses, and Medical Educators on Knowledge, Attitudes, and Implementation of Learned Clinical Skills

The goal of this study is to learn about the short- and long-term effects of two medical education approaches to teaching integrative oncology (IO) in a multi-disciplinary group of healthcare providers attending a national IO training. The main question it aims to answer is: Does active medical education approach focusing on IO-related skills is associated with better training outcomes compared to clerkship-based observation of IO clinics? Participants (trainees) will answer online survey questions about their knowledge, attitudes, and clinical proficiencies along the training process.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is conducted within a multi-centered, prospective, controlled and randomized format, using a mixed quantitative and qualitative methodology. Participants eligible for study inclusion are healthcare providers (HCPs, nurses, physicians, para-medical, or complementary medicine practitioners), age ≥ 18 years enrolling in a structured IO training program. Trainees are randomly allocated to either the Enhanced IO Training arm (Group A) or Standard IO Training arm of the study (Group B). Participants in both study arms undergo 110-hour online section of the IO training course, followed by 170-hour practical training.

Those in the Enhanced IO Training arm undergo practical training, based on the five-item competency curriculum adapted from the list of knowledge, skills, and ability-related competencies recommended by the Society for Integrative Oncology. The five-item competency-based curriculum include the following two clinical implementation competencies:

  • Anxiety relief using a mind-body modality (e.g., breathing, relaxation, guided imagery)
  • Improving pain with touch modalities (e.g., acupressure, acupuncture, reflexology), including use of acupressure points with established effectiveness in the reduction of cancer pain Participants in the Standard IO training group (Group B) will observe from the side during the IO practitioner-patient interaction.

The practical section of the training program will include two mentoring days, the first scheduled at the beginning of the 110-hour theory-based IO training, the second at the conclusion of this training. Participants in both study groups will be exposed during the two mentoring days to between 3-5 clinical IO therapeutic interactions with patients admitted to the oncology center.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 30243
        • Lin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthcare providers (nurses, physicians, para-medical, or complementary medicine practitioners) who have applied to and been accepted for the integrative oncology training program

Exclusion Criteria:

  • Healthcare providers who were not received a letter of support from the medical administrator stating commitment to allocate at least 5 hours weekly post-training to enable the trainee practicing integrative oncology care in the medical center.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced competency curriculum-based training
Trainees allocated to this arm undergo practical training, based on the five-item competency curriculum adapted from the list of knowledge, skills, and ability-related competencies recommended by the Society for Integrative Oncology.
Behavioral: Supportive Care
Competency-based training purposed to alleviate anxiety relief using a mind-body modality and improve pain with touch modalities (e.g., acupressure)
Experimental: Standard training arm
Trainees in this arm will observe from the side practitioner-patient interaction in integrative oncology setting of care
Behavioral: Supportive Care
Competency-based training purposed to alleviate anxiety relief using a mind-body modality and improve pain with touch modalities (e.g., acupressure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integrative oncology competency assessment
Time Frame: At each of the two assessment points, competencies will be assessed at the beginning of the training and 6 hours later.
Integrative oncology clinical competencies will be assessed while scoring five-item competency list provided (knowledge, skill, ability, and two clinical implementation-related competencies), using a visual analogue scale ranging between 1 (very low) and 5 (very high). Competencies will be assessed at two assessment points: 1. At the beginning of the training; 2. Following 9 months, following conclusion of the training.
At each of the two assessment points, competencies will be assessed at the beginning of the training and 6 hours later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative assessment of trainees narratives
Time Frame: 18 months
Qualitative assessment of trainees' narrative reflections will include open questions on their perspectives regarding any changes they experienced in their knowledge, skills, and ability-related competencies regarding integrative oncology. Qualitative analysis of the trainees' narratives will be conducted using ATLAS.ti software for systematic coding.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Collaborators

Israel Cancer Association
Advot Fund of Reality Group

Investigators

  • Principal Investigator: Eran Ben-Arye, MD, Carmel Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEC-050623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided at this point

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medical Education

Clinical Trials on Supportive Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe