Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni; Phone Number: +390257489731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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;
• 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.

Exclusion Criteria:

• Patients with diagnosed mental or neurological disorder that could impair the participation will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Nodule
• Other Study ID Numbers: IEO 1595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No