Decision Aid Efficacy in Low Risk Thyroid Cancer

April 11, 2026 updated by: Yinin Hu, University of Maryland, Baltimore

Efficacy of a Patient-facing Decision Aid in Reducing Decision Anxiety and Improving Decision Readiness in Low Risk Thyroid Cancer

Low-risk thyroid cancer grows very slowly. More than 99% of patients with this cancer survive for at least 5 years. There are 3 main treatment options: remove the whole thyroid, remove just the part of the thyroid with the cancer in it, or leave the cancer in the thyroid and monitor it. Survival is similar across the 3 main treatment options. It can be difficult for patients to choose a treatment option, especially when feeling anxious about the cancer diagnosis. In this study, enrolled patients will receive a decision aid after finding out they have cancer but before meeting a surgeon. This decision aid is a pamphlet. It gives information about the treatment options and a list of questions for patients to ask their surgeons at their clinic visit. The investigators will test whether this aid changes patient decision anxiety and decision readiness.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low-risk thyroid cancer or thyroid nodule suspicious for malignancy
  • English-speaking

Exclusion Criteria:

  • Prior consultation with surgeon regarding the thyroid nodule / cancer in question
  • Cancer/nodule has high risk features (e.g. extrathyroidal extension on ultrasound)
  • History of thyroid cancer
  • History of thyroid surgery
  • Currently pregnant (per patient report)

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Participants
All participants receive the intervention (decision aid)
Other: Decision Aid
Decision aid developed by Pitt & Saucke (2020) called CQUPLE (chart & question prompt list)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: (1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)
Decisional conflict will be quantified with the Decisional Conflict Scale (DCS). Range: 0 [no decisional conflict] to 100 [extremely high decisional conflict]
(1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Anxiety
Time Frame: (1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)
Anxiety about decision-making will be measured using Spielberger's State Trait Anxiety Index (STAI) 6-item state form. Range: 4.09 [highly anxious] to -4.14 [not at all anxious].
(1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)
Decision Readiness
Time Frame: (1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)
Decision readiness will be measured with the Stage of Decision-making (Stage-DM) scale. Range: 1 ["haven't begun to think about the choices"] to 6 ["have already made a decision and am unlikely to change my mind"].
(1) Baseline, (2) after receiving decision aid (approx Day 1 to Day 30), and (3) after going to surgeon clinic appointment (approx Day 2 to Day 45)
Decision Aid Acceptability
Time Frame: After receiving decision aid (approx Day 1 to Day 30)
Decision aid acceptability will be measured with the Preparation for Decision-Making (Prep-DM) scale. Range: 0 [lowest level of preparation for decision-making] to 100 [highest level of preparation for decision-making].
After receiving decision aid (approx Day 1 to Day 30)

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

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 (Estimated)

May 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMaryland-HP-00115411

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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