Integrative OncologyNCT06598020
Evaluating the Impact of an Integrative Oncology Training Program for Healthcare Providers
A study testing Supportive Care in people with Integrative Oncology and Medical Education, run by Carmel Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Integrative Oncology, Medical Education, Palliative Care
- What is being tested?
- Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthcare providers (nurses, physicians, para-medical, or complementary medicine practitioners) who have applied to and been accepted for the integrative oncology training program
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Integrative Oncology, Medical Education, Palliative Care
- Being tested
- Supportive Care
- Keywords
- Medical education, Integrative oncology, Oncology, Supportive care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareBehavioural
Competency-based training purposed to alleviate anxiety relief using a mind-body modality and improve pain with touch modalities (e.g., acupressure)
| Study group | Role | What they receive |
|---|---|---|
| Enhanced competency curriculum-based training | Experimental | 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. Receives: Behavioral: Supportive Care |
| Standard training arm | Experimental | Trainees in this arm will observe from the side practitioner-patient interaction in integrative oncology setting of care Receives: Behavioral: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrative oncology competency assessment
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.
Measured: At each of the two assessment points, competencies will be assessed at the beginning of the training and 6 hours later.
Secondary outcomes (1)
Qualitative assessment of trainees narratives
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Integrative OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Advot Fund of Reality Group, Israel Cancer Association
- Responsible party
- Principal investigator, Eran Ben-Arye, Technion, Israel Institute of Technology
- Investigators
- Eran Ben-Arye, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598020
- Sponsor's protocol ID
- TEC-050623
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this point
Publications
Witt CM, Balneaves LG, Carlson LE, Cohen M, Deng G, Fouladbakhsh JM, Kinney AY, Mehta A, Mailman J, Pole L, Rogge AA, O'Toole C, Zick SM, Helmer SM. Education Competencies for Integrative Oncology-Results of a Systematic Review and an International and Interprofessional Consensus Procedure. J Cancer Educ. 2022 Jun;37(3):499-507. doi: 10.1007/s13187-020-01829-8.
PubMed 32783117
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of an Integrative Oncology Training Program for Physicians, Nurses, and Medical Educators on Knowledge, Attitudes, and Implementation of Learned Clinical Skills
- ClinicalTrials.gov ID
- NCT06598020
- Acronym / sponsor ID
- TEC-050623
- Conditions
- Integrative Oncology, Medical Education, Palliative Care
- Keywords
- Medical education, Integrative oncology, Oncology, Supportive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Advot Fund of Reality Group, Israel Cancer Association
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced competency curriculum-based training | Experimental | Behavioral: Supportive CareTrainees 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. |
| Standard training arm | Experimental | Behavioral: Supportive CareTrainees in this arm will observe from the side practitioner-patient interaction in integrative oncology setting of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers (nurses, physicians, para-medical, or complementary medicine practitioners) who have applied to and been accepted for the integrative oncology training program
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareCompetency-based training purposed to alleviate anxiety relief using a mind-body modality and improve pain with touch modalities (e.g., acupressure) | Behavioural | Enhanced competency curriculum-based training, Standard training arm |
Primary outcome
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.
1 secondary outcome
Qualitative assessment of trainees narratives
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32783117Witt CM, Balneaves LG, Carlson LE, Cohen M, Deng G, Fouladbakhsh JM, Kinney AY, Mehta A, Mailman J, Pole L, Rogge AA, O'Toole C, Zick SM, Helmer SM. Education Competencies for Integrative Oncology-Results of a Systematic Review and an International and Interprofessional Consensus Procedure. J Cancer Educ. 2022 Jun;37(3):499-507. doi: 10.1007/s13187-020-01829-8.
- Individual participant dataSharing planned: Undecided. Undecided at this point
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Ben-Arye, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with Integrative Oncology and Medical Education, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06598020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.