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

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04472026
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 90
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 59.5
• Patients Per Site: 45
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodules; Thyroid Cancer	Behavioral: Counseling using the electronic conversation aid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
• Actual Study Start Date: Jul 16, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Intervention group Counseling using the electronic conversation aid

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.

Outcome Measures

Primary Outcome Measures

1. Qualitative analysis of the patient and clinician experience using the conversation aid [Up to 4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610
2	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• University of Florida
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Naykky Singh Ospina, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04472026
• Other Study ID Numbers: IRB202000837; 1K08CA248972-01; 5K08CA248972-02
• First Posted: Jul 15, 2020
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Florida: thyroid nodules; shared decision making
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Nodule; Thyroid Diseases

Study Results

No Results Posted as of Oct 22, 2021