Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06322160 |
| Other study ID # |
5714 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Royal Marsden NHS Foundation Trust |
| Contact |
Wanding Dr Yang, MbCHB |
| Phone |
020 7352 8171 |
| Email |
IReC[@]rmh.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Differentiated thyroid carcinoma (DTC) is currently one of the most rapidly increasing
tumours. And it is predicted to continue to rise over the next 10 years (1). Surgery to
remove the entire thyroid gland remains the gold standard treatment for low-risk DTC with
(tumour size between 1cm to 4cm). The extent of thyroid resection for low-risk disease
however is controversial. Until recently, the standard of care has been a 'one size fits all'
approach of total-thyroidectomy (TT) for >1cm DTC. This treatment has afforded excellent
overall survival rate (98-99% at 10-year) and a low recurrence rate (2-8% at 7-year) (2).
However, based on recent studies, national guidelines (American Thyroid Association 2015 and
British Thyroid Association 2014) now propose hemithyroidectomy (HT) as potentially adequate
treatment in low-risk DTC (3,4). This is because TT does not appear to offer an overall
survival advantage over HT, and subject patients to life-long hormone replacement therapy and
perhaps an increased risk of postoperative complications. However, the recent change in
guidance is only based on retrospective and observational single-centre studies which are
subject to various types of bias (5). A clear "surgical equipoise" therefor exists for
managing low-risk thyroid cancer patients. When faced with this equipoise, where clinicians
are not sure and data are still equivocal, it is even more difficult for patients to
understand the issues and make a treatment choice that is best for their individual needs and
priorities. Due to the excellent prognosis, there is an ever-increasing pool of
cancer-survivors in whom long-term quality-of-life (QoL) is more important than cure rates.
Many thyroid cancer patients have severe anxiety and long-term problems resulting in low QoL.
Unfortunately, a recent National Patient Survey showed that existing clinical equipoise (and
resulting practice variation) has resulted in high levels of confusion, dissatisfaction, and
anxiety in patients with regards to treatment decision (6). Enabling better patient
decision-making to choose the best treatment choice should lead to an improved patient
experience, higher satisfaction, better QoL and reduced health burden on the NHS (7).
Patient concerns inventory (PCI) is a condition-specific prompt list which allows patient to
formulate an individualised record of their concerns, needs and priorities that can be used
as a structure to help guide out-patient consultations (8). Patients identify, in advance of
consultations, salient issues from a specifically designed questionnaire prompt list (PCI).
This allows clinicians to focus dialogue quickly on patients' main concerns and to address
issues that patients might be otherwise have been reluctant to discuss. The original PCI was
developed by Professor Simon Rogers, consultant oral and maxillofacial surgeon of Aintree
University Hospital, Liverpool, in 2009 to provide a patient focused approach to managing
head and neck cancer (8). Since then, PCIs have also been successfully developed in other
disciplines such as breast cancer (9), burns (10), rheumatology (11), stroke care and
diabetes.
Recently we have developed a thyroid-specific patient concerns inventory (PCI-TC) [see
Appendix for Thyroid Concerns Inventory] from literature review on the unmet needs of thyroid
cancer patients followed by two phases and six rounds of modified Delphi process within a
thyroid cancer multi-disciplinary team (MDT). We hope the use of PCI-TC at diagnosis will
help tease out patient's top concerns and expectations regarding their treatment and care
going forward, thus enhancing shared decision making (SDM), so that they are better informed
and have confidence in their treatment preferences/choices within the current equipoise.
