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

NCT06322160 | Completed

• 1 other identifier: 5714
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• To explore patients' and clinicians' view and experience of the current decision-making process for low risk differentiated thyroid cancer

  • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics through the interviews conducted. Qualitative study rather than assessment.

  through study completion, an average of 1 year

• • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics.

  • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics.

  End of study

Study Arms (2)

No use of PCI-TC in clinical consultations

In this phase we aim to explore the views of the current decision-making process in thyroid cancer treatment. The patients will be approached for interview within 14 days after their consultations where the treatment decisions for their low risk differentiated thyroid cancer are made. There is no time restriction to approach clinicians for interview.

Other: Interview

User experience of PCI-TC in thyroid cancer outpatient clinic setting

First, the clinicians will be trained on how to use the PCI-TC in their outpatient clinics. A new group of patients will then be identified and recruited for the phase two study. Patients from this new group will be given the PCI-TC in a quiet area just off the waiting area prior to the consultation. They will be asked to tick items on the PCI-TC list which they wish to discuss. The clinicians will conduct the consultation using the ticked PCI-TC as a guide and discuss with patients regarding the treatment plan for their thyroid cancer. The patients will be approached for interview within 14 days after their consultations. The clinicians will be approached for interview after all recruited patients in phase two study have had their consultation regarding their cancer treatment.

Other: Interview

Interventions

Interview OTHER

Interview with individual participant will take place via online videoconferencing MS Teams

No use of PCI-TC in clinical consultations; User experience of PCI-TC in thyroid cancer outpatient clinic setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We also aim to include 4 consultants head and neck and thyroid surgeons in the study centres. Patients who have been diagnosed with low risk differentiated thyroid carcinoma.

You may qualify if:

• 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

You may not qualify if:

• 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 either Pregnant or breast-feeding
• Patient with hyper- or hypothyroidism who is a candidate for surgery
• Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease
• Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.
• Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent
• Patient who is not able to read write and speak English.
• Consultant surgeons who diagnose and/or manage low-risk well-differentiated thyroid cancer for less than ten patients per year.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• ENT UK: collaborator

Study Sites (2)

Guys & St Thomas

London, United Kingdom

Location

UCLH

London, United Kingdom

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 20, 2024
• Study Start: May 3, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)