RecruitingNCT06855680

The EMIRATES Study

The EMIRATES Study - Development and Evaluation of Thyroid Cancer Patient Decision Aid (PDA-TC) - Pilot Study


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

15 participants

Start Date

Jun 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether people with low-risk, small papillary or follicular thyroid cancer can safely avoid having the entire thyroid removed, opting instead for less invasive management after partial removal. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with a low-risk, well-differentiated thyroid cancer (papillary or follicular) measuring 1–4 cm - The diagnosis was made either before surgery (via fine needle biopsy) or confirmed after a partial thyroid removal - You can speak and write English **You may NOT be eligible if:** - Your thyroid cancer has aggressive features (e.g., tall cell, Hurthle cell, or solid variants) - Your cancer is multifocal (in more than one spot), bilateral (both sides), or has spread beyond the thyroid gland - You have involved lymph nodes or distant spread - You have a family history of thyroid cancer - You are pregnant or breastfeeding - You have thyroid hormone problems requiring surgery - You have other types of thyroid cancer (e.g., medullary or anaplastic) - You previously had a thyroidectomy for other reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Wigan, United Kingdom

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NCT06855680