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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
RECRUITING
Wigan
Contact Information
Primary
Wanding Yang
Wanding.Yang@rmh.nhs.uk
02073528171
Time Frame
Start Date: 2024-06-19
Estimated Completion Date: 2025-10-14
Participants
Target number of participants: 15
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Wrightington, Wigan and Leigh NHS Foundation Trust
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov