Background: Most cases of thyroid cancer will have an excellent prognosis. There is emerging data to show we are over-treating many patients with low-risk thyroid cancer. The role of active surveillance (AS) as an alternative to surgery in the management of low-risk PTC is well established. Despite the growing body of evidence to support the option of AS, many clinicians do not feel comfortable in selecting appropriate patients.
Aims:
1) To determine if the application of a clinical support tool (CST) can identify patients who are appropriate for active surveillance
2) To assess whether the CST increases the number of patients with thyroid nodules <2cm that are managed with active surveillance?
Method: Our team will lead a randomised non-blinded cross-sectional multicentre study to evaluate the role of a clinical support tool in helping clinicians decide whether their patient is suitable for active surveillance.
Patients aged 18+ with a thyroid nodule <2cm with Bethesda III, V or VI biopsy result are eligible for inclusion. Clinicians will be block randomised in 1:1 fashion to receive either a modified clinical support tool (mCST) – control group or the clinical support tool (CST) – intervention group. The mCST will provide information about outcomes for active surveillance (including risk of nodule growth, metastases and death) and the CST will provide this information as well as whether the patient will be suitable for active surveillance based on data entered into the tool. Patients will decide their treatment in consultation with their clinician and their outcomes will be followed over time.
Outcomes: The following metrics will be assessed; rates of disease progression, rates of disease recurrence, patient quality of life outcomes (assessed through validated questionnaires EORTC QLQ C30 and THY34), and clinician acceptability of the tool. We anticipate the study duration of 36 months.