Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma, Papillary Thyroid Microcarcinoma
Conditions
Keywords
decision, decision aid, thyroid cancer, papillary thyroid microcarcinoma, decision readiness, decisional conflict, overtreatment
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.
Interventions
OTHERDecision Aid
Decision aid developed by Pitt \& Saucke (2020) called CQUPLE (chart \& question prompt list)
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Decisional conflict will be quantified with the Decisional Conflict Scale (DCS). Range: 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 \[not at all anxious\]. |
| 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 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 \["have already made a decision and am unlikely to change my mind"\]. |
| Decision Aid Acceptability | 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 \[highest level of preparation for decision-making\]. |
Countries
United States
Contacts
CONTACTYinin Hu, MD
Outcome results
None listed