Sponsor study identifier
observational
15
1 country
1
Study Start
June 19, 2024
Actual (reported)Primary Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2024
Actual (reported)October 3, 2024
Actual (reported)March 4, 2025
Actual (reported)October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
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)
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom
First Submitted
October 3, 2024
First Posted
March 4, 2025
Study Start
June 19, 2024
Actual (reported)Primary Completion
October 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
October 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 21, 2025
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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