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

NCT04463719 | Completed Results DMC

• 4 other identifiers: IRB202000837-N1K08CA248972-015K08CA248972-02OCR34613
• Study Type: interventional
• Target: 107
• 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. 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.

Conditions

Thyroid Nodules; Thyroid Cancer

Keywords

thyroid nodules; shared decision making

Outcome Measures

Primary Outcomes (1)

• Proportion of Eligible Patients for Feasibility

  Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up).

  at 6 months of follow up

Secondary Outcomes (16)

• Patient's Acceptance to Participate in the Study

  first visit

• Adequate Randomization

  initial clinical visit

• Completeness of Baseline Survey (Patients)

  baseline

• Patient Survey (6 Months)

  6 months

• Clinician Baseline Survey

  baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Counseling using the electronic conversation aid

Behavioral: Counseling using the electronic conversation aid

Control Group

ACTIVE COMPARATOR

Routine counseling only

Behavioral: counseling by routine care

Interventions

Counseling using the electronic conversation aid BEHAVIORAL

Patients receive counseling about thyroid biopsy with the use of the conversation aid.

Intervention group

counseling by routine care BEHAVIORAL

Patients receive counseling by routine care without the use of the conversation aid

Control 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) 273-8655

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: February 20, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)