The EMIRATES Study
ConditionDifferentiated Thyroid Cancer (DTC)
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients will be identified from the Thyroid MDT lists at the respective study centres by the local head and neck surgical team (patient's direct care team)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 2 trial groupsGroup A: Control arm
Group B: PDA arm
Trial outcomes
Primary outcomes
1
Recruitment rate
Successful recruitment rate of all eligible patients: the percentage of eligible patients who agree to participate out of all eligible patients screened and its 95% confidence interval.
Time frame
From enrolment for 9 monthsSecondary outcomes
1
Percentage of participants in PDA arm who use the PDA-TC
Percentage of participants in PDA arm who use the PDA-TC to assist with the decision making process for their cancer treatment.
Time frame
From enrolment for 9 months2
Difference of the overall score of the decisional conflict scale
The difference of the overall score of the decisional conflict scale after the consultation with and without the use of PDA-TC. The decisional conflict scale is a 5-point scale with 16 items and the lower the score, the better the outcome. This questionnaire is completed after the initial and second consultation. The satisfaction with decision scale is a 5-point scale with 6 items and the higher the score, the better the outcome. This questionnaire is completed after the second consultation. The preparation for decision making scale is a 5-point scale with 10 items and the higher the score, the better the outcome. The questionnaire is taken after the second consultation.
Time frame
From enrolment for 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal Marsden NHS Foundation Trust
Lead sponsor
Wrightington, Wigan and Leigh NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov