Differentiated Thyroid Cancer (DTC)NCT07536412
Decision Aid Efficacy in Low Risk Thyroid Cancer
A study testing Decision Aid in people with Differentiated Thyroid Cancer (DTC) and Papillary Thyroid Microcarcinoma, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma, Papillary Thyroid Carcinoma
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 15 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low-risk thyroid cancer or thyroid nodule suspicious for malignancy
- English-speaking
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21210
Yinin Hu, MD, 630-854-0191, yinin.hu@som.umaryland.edu
About this study
Official title: 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.
- Conditions
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma, Papillary Thyroid Carcinoma
- Being tested
- Decision Aid
- Keywords
- decision, decision aid, thyroid cancer, papillary thyroid microcarcinoma, decision readiness, decisional conflict, overtreatment
- Medical subject headings
- Papillary Thyroid Microcarcinoma, Thyroid Cancer, Papillary, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Decision aid developed by Pitt \& Saucke (2020) called CQUPLE (chart \& question prompt list)
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants receive the intervention (decision aid) Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
Decisional conflict will be quantified with the Decisional Conflict Scale (DCS). Range: 0 [no decisional conflict] to 100 [extremely high decisional conflict]
Measured: (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 outcomes (3)
Decision Anxiety
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].
Measured: (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
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"].
Measured: (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
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].
Measured: After receiving decision aid (approx Day 1 to Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid Cancer (DTC)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinin Hu, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536412
- Sponsor's protocol ID
- UMaryland-HP-00115411
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Patient-facing Decision Aid in Reducing Decision Anxiety and Improving Decision Readiness in Low Risk Thyroid Cancer
- ClinicalTrials.gov ID
- NCT07536412
- Acronym / sponsor ID
- UMaryland-HP-00115411
- Conditions
- Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma, Papillary Thyroid Carcinoma
- Keywords
- decision, decision aid, thyroid cancer, papillary thyroid microcarcinoma, decision readiness, decisional conflict, overtreatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Other: Decision AidAll participants receive the intervention (decision aid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low-risk thyroid cancer or thyroid nodule suspicious for malignancy
- English-speaking
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidDecision aid developed by Pitt \& Saucke (2020) called CQUPLE (chart \& question prompt list) | Other | All Participants |
Primary outcome
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]
3 secondary outcomes
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)
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 Aid Acceptability
Time frame: After receiving decision aid (approx Day 1 to Day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Differentiated Thyroid Cancer (DTC) and Papillary Thyroid Microcarcinoma, run by University of Maryland, Baltimore at 1 site 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinin Hu, MD (630-854-0191, yinin.hu@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.