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

March 28, 2024 updated by: University of Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Naykky Singh Ospina
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Victor Montori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Counseling using the electronic conversation aid
Behavioral: Counseling using the electronic conversation aid
Patients receive counseling about thyroid biopsy with the use of the conversation aid.
Active Comparator: Control Group
Routine counseling only
Behavioral: counseling by routine care
Patients receive counseling by routine care without the use of the conversation aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients for feasibility
Time Frame: at 6 months of follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Naykky Singh Ospina, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202000837-N
  • 1K08CA248972-01 (U.S. NIH Grant/Contract)
  • 5K08CA248972-02 (U.S. NIH Grant/Contract)
  • OCR34613 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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