The EMIRATES Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

This pilot study will take place in thyroid outpatient clinics. It will have two study arms running in consecutive order: first, a Control arm where standard care will take place without PDA-TC, then a Patient Decision Aid (PDA) arm where the PDA-TC is implemented into the clinical practice. Within each arm, eligible patients will attend two thyroid cancer outpatient clinical consultations during which the patient will make a shared decision with their clinicians regarding surgical treatment between hemithyroidectomy and total thyroidectomy. In the PDA arm, the PDA TC pamphlet will be introduced to study participants after the initial clinical consultation. The participants will be encouraged to read and digest information related to the disease and treatment options on PDA-TC before returning for their second consultation where a treatment decision will be made together with their clinicians. Participants will be asked to complete the Decisional Conflict Scale questionnaire after each consultation in both study arms. The patient will also complete a Satisfaction with Decision Scale questionnaire and a Preparation for Decision Making Scale questionnaire after the second consultation in both arms.

Eligibility criteria

Qualifiers

Aged over 18

Both genders

Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or

Confirmed following diagnostic hemithyroidectomy

Disqualifiers

Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)

Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.

Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases

Patients who are diagnosed with thyroid cancer which is of a familial disease

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

15 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Royal Marsden NHS Foundation Trust

Lead sponsor

Wrightington, Wigan and Leigh NHS Foundation Trust

Collaborator