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NCT06322160Completed

The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway.

Status (registry)
Completed
Study type
Observational
Enrollment
19 (actual)
First submitted
6 Feb 2024
Start date
3 May 2023
Primary completion date
3 Sept 2024
Lead sponsor
Royal Marsden NHS Foundation Trust
NCT number
NCT06322160

What you commit to

  • Study type: Observational
  • Participants enrolled: 19
  • From 3 May 2023 to the primary completion date, 3 Sept 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with hyper- or hypothyroidism who is a candidate for surgery
  • Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.

Other illness

  • Patients who are diagnosed with tumour with adverse features this includes:
    • Tumour with poor differentiated cytology or variants with bad prognosis (tall cell, columnar cell, Hurthle cell, solid variant)
    • Tumour, which is multifocal, bilateral, with extrathyroidal extension, with perineural or lymphovascular invasion.
    • Tumour with clinically or radiologically involved nodes or distant metastases
    • Tumour which is of a familial disease
  • Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease
  • Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent
  • Consultant surgeons who diagnose and/or manage low-risk well-differentiated thyroid cancer for less than ten patients per year.

Other

  • Patient who is either Pregnant or breast-feeding
  • Patient who is not able to read write and speak English.

Who the study is looking for

  • 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
  • Consultant head and neck and thyroid surgeons who directly involve in the diagnosis and/or management of low-risk well-differentiated thyroid cancer (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm for at least ten patients per year.
  • Both genders
  • Able to communicate in spoken and written English

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCLH
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Guys & St Thomas
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.