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

University of Florida

Status: Completed

Conditions: Thyroid Cancer; Thyroid Nodules

Treatments: Behavioral: Counseling using the electronic conversation aid; Behavioral: counseling by routine care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04463719

5K08CA248972-02 (U.S. NIH Grant/Contract)

IRB202000837-N

1K08CA248972-01 (U.S. NIH Grant/Contract)

OCR34613 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Intervention group

Experimental group

Description:

Counseling using the electronic conversation aid

Treatment:

Behavioral: Counseling using the electronic conversation aid

Control Group

Active Comparator group

Description:

Routine counseling only

Treatment:

Behavioral: counseling by routine care