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NCT06855680

The EMIRATES Study

StatusUnknown
PhaseNot specified
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Recruiting
  2. Minor Study description expanded, about 2 wordsv2
  3. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Recruitment rate
Timeframe: From enrolment for 9 months

Secondary (2)

Percentage of participants in PDA arm who use the PDA-TC
Difference of the overall score of the decisional conflict scale

Arms and interventions

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.

Sites

1 site in 1 country

  • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation TrustWigan, United Kingdom