Decision Aid and Thyroid Nodules Management

Sponsor

Stony Brook University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05264857

Collaborator

(none)

134

Enrollment

Location

Arm

55.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Behavioral: Thyroid Nodule Management Education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer

Actual Study Start Date :

Feb 8, 2022

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thyroid nodule information	Behavioral: Thyroid Nodule Management Education Participants will receive information about thyroid nodules and their management

Arm

Intervention/Treatment

Experimental: Thyroid nodule information

Behavioral: Thyroid Nodule Management Education

Participants will receive information about thyroid nodules and their management

Outcome Measures

Primary Outcome Measures

Rate of congruence between informed values and treatment choice [6 months from surgery or surgical consultation date]
Percent of patients with congruence between treatment option and informed values based on a survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

History of thyroid surgery
History of thyroid cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook University Cancer Center	Stony Brook	New York	United States	11794

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator: Lukasz Czerwonka, MD, Lukasz.Czerwonka@stonybrookmedicine.edu

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lukasz Czerwonka, Head and Neck Surgeon, Stony Brook University

ClinicalTrials.gov Identifier:

NCT05264857

Other Study ID Numbers:

SBU-DECISION-AID-THYROID

First Posted:

Mar 3, 2022

Last Update Posted:

Mar 3, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Nodule

Thyroid Diseases

Study Results

No Results Posted as of Mar 3, 2022