The EMIRATES Study

NCT06855680 | Recruiting

• 1 other identifier: CCR5869
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Differentiated Thyroid Cancer (DTC)

Outcome Measures

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.

  From enrolment for 9 months

Secondary Outcomes (2)

• Percentage of participants in PDA arm who use the PDA-TC

  From enrolment for 9 months

• Difference of the overall score of the decisional conflict scale

  From enrolment for 9 months

Study Arms (2)

Control arm

Control arm will follow standard clinical practice. Patients with newly diagnosed low-risk DTC will be recruited to attend two outpatient clinical appointments as part of their standard thyroid cancer care pathway. In the initial consultation, thyroid cancer clinicians will discuss with patient the available treatment options (i.e. total thyroidectomy and hemithyroidectomy) for the low-risk DTC and their associated risks and benefits. Instead of making the treatment decision straight away, patients will be allowed to a week to digest the information and to consider the options. A week later, patients will return for the second outpatient consultation where they will decide on the treatment with their clinicians.

PDA arm

In the PDA arm, the study procedure will be the same as in control arm except that the PDA-TC pamphlet will be introduced to patient after the first outpatient clinical consultation. Patients are allowed to take the PDA-TC home to read and digest the information before returning for their second outpatient consultation a week later. The data collection timing and measures in the PDA arm will remain the same as in the control arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• Aged over 18
• Both genders
• Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:
• Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade \[see appendix for the Thy classification\] or
• Confirmed following diagnostic hemithyroidectomy
• Able to communicate in spoken and written English

You may not qualify if:

• 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
• Patient who is either Pregnant or breast-feeding
• Patient with hyper- or hypothyroidism who is a candidate for surgery
• Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease
• Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.
• Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent
• Patient who is not able to read write and speak English

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Wrightington, Wigan and Leigh NHS Foundation Trust: collaborator

Study Sites (1)

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Wigan, United Kingdom

RECRUITING

Central Study Contacts

Wanding Yang

CONTACT

02073528171; Wanding.Yang@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: March 4, 2025
• Study Start: June 19, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 14, 2025
• Last Updated: March 21, 2025

Record last verified: 2024-10

Locations

GB (1)