NCT06342739

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Gabriella Pravettoni

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

March 23, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations