AIM1: 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: NCT04472026
• Other study ID #: IRB202000837
• Secondary ID: K08CA248972
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2020
• 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 when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• 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
This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process.

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	Qualitative analysis of the patient and clinician experience using the conversation aid	The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid.	Up to 4 weeks