AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

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. This entry (Aim 1) has an associated study (Aim 2) registered under NCT04463719

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Key information

Conditions

Thyroid Nodules Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling using the electronic conversation aid

Behavioral

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.

Primary outcomes

Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid

Time frame: Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians)

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jul 15, 2020
Registry last updated: Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed