Decision Aid Efficacy in Low Risk Thyroid Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Low-risk thyroid cancer or thyroid nodule suspicious for malignancy

English-speaking

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Decision Aid

    Other intervention

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

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: All ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Decisional Conflict

Decisional conflict will be quantified with the Decisional Conflict Scale (DCS). Range: 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]

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 outcomes

1

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 \[not at all anxious\].

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)
2

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 \["have already made a decision and am unlikely to change my mind"\].

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)
3

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 \[highest level of preparation for decision-making\].

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

Other outcomes

Sponsors and contacts

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