Decision Aid and Thyroid Nodules Management

Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule
• Intervention / Treatment: Behavioral: Thyroid Nodule Management Education

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Flores; Phone Number: 631-444-9044; Email: Carla.GomezjuradoFlores@stonybrookmedicine.edu
• Study Contact Backup: Name: Caterina Vacchi-Suzzi; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Cancer Center
      • Contact: Carla Flores; Phone Number: 631-444-9044; Email: Carla.GomezjuradoFlores@stonybrookmedicine.edu
      • Contact: Caterina Vacchi-Suzzi; Phone Number: 6312162993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Lukasz Czerwonka, MD, Lukasz.Czerwonka@stonybrookmedicine.edu

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Anticipated): September 30, 2026
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: SBU-DECISION-AID-THYROID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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