AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Thyroid Cancer Clinical Trial

Official title:

Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463719
• Other study ID #: IRB202000837-N
• Secondary ID: 1K08CA248972-015
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults >18 years old presenting for evaluation of a thyroid nodule

Exclusion Criteria:

• Patients with hyperthyroidism

• Patients with previous biopsy of the nodule of interest

• Pregnant patients

• Prisoners

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Behavioral:
• Counseling using the electronic conversation aid
Patients receive counseling about thyroid biopsy with the use of the conversation aid.
• counseling by routine care
Patients receive counseling by routine care without the use of the conversation aid

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible patients for feasibility	Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).	at 6 months of follow up