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Trial Title: EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem

NCT ID: NCT05909020

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: No intervention.
Description: No intervention.
Arm group label: Patients
Arm group label: Staff

Summary: Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway? Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

Detailed description: The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.

Criteria for eligibility:

Study pop:
Patients Recruitment will aim for variation in age, ethnicity, socio-economic status, presenting symptoms. Clinicians Clinical staff involved in HNC diagnosis. Varying in seniority (consultant, registrar) and specialty (ENT, maxillofacial)

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: Patients: - Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC - Participants willing and able to give informed consent for participation in the study. Clinicians: - Staff at participating sites involved in the diagnostic pathway for people with suspected HNC. Exclusion Criteria: - Individuals who do not meet the inclusion criteria.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Leeds Teaching Hospitals NHS Trust

Address:
City: Leeds
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Unknown Unknown

Investigator:
Last name: James Moor
Email: Principal Investigator

Facility:
Name: Liverpool University Hospitals NHS Foundation Trust

Address:
City: Liverpool
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Shirley Pringle

Investigator:
Last name: Katharine Davies
Email: Principal Investigator

Facility:
Name: Luton & Dunstable University Hospital

Address:
City: Luton
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Nithin George

Investigator:
Last name: Chrysostomos Tornari
Email: Principal Investigator

Facility:
Name: Oxford NHS Foundation Trust

Address:
City: Oxford
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Iqbal Mohammed

Investigator:
Last name: Stuart Winter
Email: Principal Investigator

Start date: March 17, 2023

Completion date: November 30, 2023

Lead sponsor:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Collaborator:
Agency: University of Leeds
Agency class: Other

Source: Royal Marsden NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05909020

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