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NCT Number: NCT07536412

Decision Aid Efficacy 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.

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Key information

Conditions

Differentiated Thyroid Cancer (DTC) Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillary Thyroid Carcinoma Papillary Thyroid Microcarcinoma Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Decision Aid

Other

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

Primary outcomes

  1. 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]

Secondary outcomes

  1. 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].

  2. 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"].

  3. 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].

Study contacts

Contact information is provided by the study sponsor or research team.

Yinin Hu, MD

CONTACT

[email protected]

630-854-0191

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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