Back to resultsDecision Aid and Thyroid Nodules Management
Primary Purpose
Thyroid Nodule
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thyroid Nodule Management Education
Sponsored by
About this trial
This is an interventional health services research trial for Thyroid Nodule
Eligibility Criteria
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
Sites / Locations
- Stony Brook University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thyroid nodule information
Arm Description
Outcomes
Primary Outcome Measures
Rate of congruence between informed values and treatment choice
Percent of patients with congruence between treatment option and informed values based on a survey
Secondary Outcome Measures
Full Information
NCT ID
NCT05264857
First Posted
February 17, 2022
Last Updated
April 19, 2023
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT05264857
Brief Title
Decision Aid and Thyroid Nodules Management
Official Title
Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thyroid nodule information
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Thyroid Nodule Management Education
Intervention Description
Participants will receive information about thyroid nodules and their management
Primary Outcome Measure Information:
Title
Rate of congruence between informed values and treatment choice
Description
Percent of patients with congruence between treatment option and informed values based on a survey
Time Frame
6 months from surgery or surgical consultation date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Flores
Phone
631-444-9044
Email
Carla.GomezjuradoFlores@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Vacchi-Suzzi
Phone
631-216-2993
Email
caterina.vacchi-suzzi@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Czerwonka, MD
Organizational Affiliation
Lukasz.Czerwonka@stonybrookmedicine.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Flores
Phone
631-444-9044
Email
Carla.GomezjuradoFlores@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Caterina Vacchi-Suzzi
Phone
6312162993
Email
caterina.vacchi-suzzi@stonybrookmedicine.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Decision Aid and Thyroid Nodules Management
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