NCT07536412

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2029

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 2, 2026

Last Update Submit

April 11, 2026

Conditions

Differentiated Thyroid Cancer (DTC)Papillary Thyroid MicrocarcinomaPapillary Thyroid Carcinoma

Keywords

decisiondecision aidthyroid cancerpapillary thyroid microcarcinomadecision readinessdecisional conflictovertreatment

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict

    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 Outcomes (3)

  • Decision Anxiety

    (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

    (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

    After receiving decision aid (approx Day 1 to Day 30)

Study Arms (1)

All Participants

EXPERIMENTAL

All participants receive the intervention (decision aid)

Other: Decision Aid

Interventions

Decision AidOTHER

Decision aid developed by Pitt \& Saucke (2020) called CQUPLE (chart \& question prompt list)

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Papillary Thyroid MicrocarcinomaThyroid Cancer, PapillaryThyroid Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Yinin Hu, MD

CONTACT

630-854-0191yinin.hu@som.umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 17, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2029

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)