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

NCT ID: NCT04463719

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-20

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Nodules Thyroid Cancer

Keywords

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thyroid nodules shared decision making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention group

Counseling using the electronic conversation aid

Group Type EXPERIMENTAL

Counseling using the electronic conversation aid

Intervention Type BEHAVIORAL

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

Control Group

Routine counseling only

Group Type ACTIVE_COMPARATOR

counseling by routine care

Intervention Type BEHAVIORAL

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

Interventions

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Counseling using the electronic conversation aid

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

Intervention Type BEHAVIORAL

counseling by routine care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naykky Singh Ospina

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K08CA248972-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5K08CA248972-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR34613

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202000837-N

Identifier Type: -

Identifier Source: org_study_id