Menu
Not yet recruiting NCT07536412

Decision Aid Efficacy in Low Risk Thyroid Cancer

No phase Interventional Differentiated Thyroid Cancer (DTC) Papillary Thyroid Microcarcinoma Papillary Thyroid Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision Aid.
Who it may be relevant to
Registry conditions: Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma, Papillary Thyroid Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Maryland, Baltimore — Baltimore

Identifiers

NCT: NCT07536412 · UMaryland-HP-00115411

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗