Thyroid NoduleNCT06342739
Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations
An observational study of Thyroid Nodule, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2022to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of benign thyroid nodule with a scheduled consultation with endocrinologist and/or surgeon and/or radiologist to discuss treatment options related to benign thyroid nodule at European Institute of Oncology
Who may be able to join
- Specifically, to be eligible for the inclusion in this study, each patient has to fulfill all these criteria:
- diagnosis of benign thyroid nodule;
- scheduled consultation with endocrinologist and/or surgeon and/or radiologist to discuss treatment options related to benign thyroid nodule;
- ≥18 years old at the time of recruitment;
- proper understanding of Italian language;
- fluent Italian speaker;
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- able to comply to requested procedures to obtain audio-video recording.
- Each professional has to fulfill these criteria:
- proper understanding of Italian language;
- fluent Italian speaker;
- able to comply to requested procedures to obtain audio-video recording.
Who cannot join
- Patients with diagnosed mental or neurological disorder that could impair the participation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Gabriella Pravettoni
About this study
Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules.
Read the detailed description
Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. Endocrinologist and/or surgeon and/or radiologist involved in the consultation will be recruited as well.
Before the scheduled consultation with endocrinologist, surgeon or radiologist, benign thyroid nodules patients will be screened for eligibility by a researcher and a physician from the Interventional Radiology Unit.
If patients meet all the inclusion criteria, they will be contacted by the researcher and proposed to participate. The day of the consultations, researcher will meet participants face to face, they will answer any questions should arise and will ask them to sign the informed consent form.
Benign thyroid nodules patients have a specific clinical pathway, in which they may have consultations with endocrinologists, and/or with surgeon, and/or with radiologists. Patients will be recruited before their first consultation and then, if they are scheduled to have other consultations with other professionals, will be recruited as well for the following consultations.
- Conditions
- Thyroid Nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign thyroid nodules group | Participants with benign thyroid nodules involved in a consultation with endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction
The primary endpoint of our research is to test the predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction with tha analysis of audio and video recording file.
Variables analyzed from audio recording will be use of words, verbal synchrony, empathic communication; variables analyzed from video recording will be facial emotion expression and facial emotion expression synchrony
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start23 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342739
- Sponsor's protocol ID
- IEO 1595
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations
- ClinicalTrials.gov ID
- NCT06342739
- Acronym / sponsor ID
- IEO 1595
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Apr 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.
Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules.
Detailed description
Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. Endocrinologist and/or surgeon and/or radiologist involved in the consultation will be recruited as well.
Before the scheduled consultation with endocrinologist, surgeon or radiologist, benign thyroid nodules patients will be screened for eligibility by a researcher and a physician from the Interventional Radiology Unit.
If patients meet all the inclusion criteria, they will be contacted by the researcher and proposed to participate. The day of the consultations, researcher will meet participants face to face, they will answer any questions should arise and will ask them to sign the informed consent form.
Benign thyroid nodules patients have a specific clinical pathway, in which they may have consultations with endocrinologists, and/or with surgeon, and/or with radiologists. Patients will be recruited before their first consultation and then, if they are scheduled to have other consultations with other professionals, will be recruited as well for the following consultations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benign thyroid nodules group | – | –Participants with benign thyroid nodules involved in a consultation with endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of benign thyroid nodule with a scheduled consultation with endocrinologist and/or surgeon and/or radiologist to discuss treatment options related to benign thyroid nodule at European Institute of Oncology
Key inclusion criteria (11 listed)
- Specifically, to be eligible for the inclusion in this study, each patient has to fulfill all these criteria:
- diagnosis of benign thyroid nodule;
- scheduled consultation with endocrinologist and/or surgeon and/or radiologist to discuss treatment options related to benign thyroid nodule;
- ≥18 years old at the time of recruitment;
- proper understanding of Italian language;
Key exclusion criteria (1 listed)
- Patients with diagnosed mental or neurological disorder that could impair the participation will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction
Time frame: 1 month
The primary endpoint of our research is to test the predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction with tha analysis of audio and video recording file. Variables analyzed from audio recording will be use of words, verbal synchrony, empathic communication; variables analyzed from video recording will be facial emotion expression and facial emotion expression synchrony
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
Gabriella Pravettoni principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by European Institute of Oncology at 1 site in Italy.
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 11 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 2 Apr 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 Italy. 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?
Contact Gabriella Pravettoni (+390257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.