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Thyroid NodulesNCT04463719

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

A study testing Counseling using the electronic conversation aid and counseling by routine care in people with Thyroid Nodules and Thyroid Cancer, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Thyroid Nodules, Thyroid Cancer
What is being tested?
Counseling using the electronic conversation aid and counseling by routine care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
2 sitesUnited States
Study dates
20 Feb 2022to 30 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Florida

    Gainesville, Florida, 32610

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Being tested
Counseling using the electronic conversation aid, counseling by routine care
Keywords
thyroid nodules, shared decision making
Medical subject headings
Thyroid Nodule, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counseling using the electronic conversation aidBehavioural

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

  • counseling by routine careBehavioural

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

Study groups in NCT04463719
Study groupRoleWhat they receive
Intervention groupExperimentalCounseling using the electronic conversation aid
Receives: Behavioral: Counseling using the electronic conversation aid
Control GroupActive comparatorRoutine counseling only
Receives: Behavioral: counseling by routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: at 6 months of follow up

Secondary outcomes (16)

  1. Patient's Acceptance to Participate in the Study

    From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study

    Measured: first visit

  2. Adequate Randomization

    Proportion of patients that were randomized and completed the study

    Measured: initial clinical visit

  3. Completeness of Baseline Survey (Patients)

    Proportion of patients that completed the baseline survey

    Measured: baseline

  4. Patient Survey (6 Months)

    Proportion of patients that completed the 6 month survey

    Measured: 6 months

  5. Clinician Baseline Survey

    Measured: baseline

  6. Knowledge

    To assess knowledge transfer related to thyroid nodules, patients completed a 12-item questionnaire with Yes/No and "I don't know" response options, related to thyroid nodule knowledge. Higher score indicate increased number of correct answers.

    Measured: baseline

  7. Decisional Conflict

    Decisional conflicts reflects degree of conflict with the decision made. This construct was evaluated with a validated questionnaire that includes 16-items, with the total score transformed into a 1-100 scale, with higher scores indicating greater decisional conflict.

    Measured: baseline

  8. OPTION Score

    Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100)

    Measured: baseline

  9. Visit Duration

    Length of the clinical visit

    Measured: baseline

  10. Diagnostic Decision

    Proportion of patients undergoing thyroid biopsy

    Measured: baseline

  11. Fidelity

    Fidelity of use of the conversation aid during clinical visit, evaluating using 12 items during review of clinical visit. Higher percentage refers to higher number of items observed.

    Measured: baseline

  12. Risk Communication

    Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome.

    Measured: baseline

  13. Satisfaction With the Communication (Patient)

    Likert score, lower number more satisfied, 1-7

    Measured: baseline

  14. Satisfaction With the Visit (Clinician)

    Likert score, higher numbers better, 1-5 options

    Measured: baseline

  15. Worry About Thyroid Cancer

    Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot

    Measured: baseline

  16. Distress Due to Thyroid Nodule (6 Months)

    Impact of Event Scale evaluates distress with a new medical situation (new thyroid nodule in this case). The scale includes 6 items, with a score range from 0 to 24 points, with higher values indicating more distress.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start20 Feb 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04463719
Sponsor's protocol ID
IRB202000837-N
Other IDs
1K08CA248972-01, 5K08CA248972-02, OCR34613
Status last verified
Dec 2024
First submitted
6 Jul 2020
Last updated
10 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Algarin Perneth S, Patel U, Ortiz Rocha A, Barb D, Acosta G, Srihari A, Dziegielewski P, Castro MR, Dean D, Ryder M, Hargraves I, Bylund C, Roy A, Zhang Z, Montori VM, Brito JP, Singh Ospina NM. Evaluation of a conversation aid for patients with thyroid nodules considering a biopsy: pilot multicenter randomized control trial. Endocrine. 2026 Mar 9;91(1):92. doi: 10.1007/s12020-025-04517-z.

    PubMed 41801576

Questions about this trial

What is this clinical trial studying?

A study testing Counseling using the electronic conversation aid and counseling by routine care in people with Thyroid Nodules and Thyroid Cancer, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eligible Patients for Feasibility (time frame: at 6 months of follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04463719, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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