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

NCT04472026 | Completed Results DMC

• 2 other identifiers: IRB202000837K08CA248972
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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

Conditions

Thyroid Nodules; Thyroid Cancer

Keywords

thyroid nodules; shared decision making

Outcome Measures

Primary Outcomes (1)

• 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 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)

Study Arms (1)

Intervention group

EXPERIMENTAL

Counseling using the electronic conversation aid

Behavioral: Counseling using the electronic conversation aid

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with hyperthyroidism
• Patients with previous biopsy of the nodule of interest
• Pregnant patients
• Prisoners

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Naykky Singh Ospina
• Organization: University Of Florida

naykky.singhospina@medicine.ufl.edu

352) 273-8656

Study Officials

• Naykky Singh Ospina

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: July 16, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)