NCT05264857

Brief Summary

Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Feb 2022

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2022Sep 2027

Study Start

First participant enrolled

February 8, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

5.6 years

First QC Date

February 17, 2022

Last Update Submit

October 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of congruence between informed values and treatment choice

    Percent of patients with congruence between treatment option and informed values based on a survey

    6 months from surgery or surgical consultation date

Study Arms (1)

Thyroid nodule information

EXPERIMENTAL
Behavioral: Thyroid Nodule Management Education

Interventions

Participants will receive information about thyroid nodules and their management

Thyroid nodule information

Eligibility Criteria

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

You may qualify if:

  • Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
  • Thyroid nodule size less or equal to 2cm

You may not qualify if:

  • History of thyroid surgery
  • History of thyroid cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lukasz Czerwonka, MD

    Lukasz.Czerwonka@stonybrookmedicine.edu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head and Neck Surgeon

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 3, 2022

Study Start

February 8, 2022

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations