| NCT ID | NCT06855680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Differentiated Thyroid Cancer (DTC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-06-19 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade \[see appendix for the Thy classification\] or 2. Confirmed following diagnostic hemithyroidectomy * Able to communicate in spoken and written English Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06855680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Differentiated Thyroid Cancer (DTC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855680 currently recruiting?
Yes, NCT06855680 is actively recruiting participants. Contact the research team at Wanding.Yang@rmh.nhs.uk for enrollment information.
Where is the NCT06855680 trial being conducted?
This trial is being conducted at Wigan, United Kingdom.
Who is sponsoring the NCT06855680 clinical trial?
NCT06855680 is sponsored by Royal Marsden NHS Foundation Trust. The trial plans to enroll 15 participants.
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