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

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Other: No intervention.

• Registration Number: NCT05909020
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2023-03-17
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	No intervention.	Approximately 150 adults referred for suspected HNC will be recruited.
Staff	No intervention.	Approximately 15 ENT and Maxillofacial) clinicians will be recruited.

Primary Outcome Measures

Name	Time	Method
Inventory and specification for the SYmptom iNput Clinical (SYNC) system	September 2022 - August 2023	To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system

Secondary Outcome Measures

Name	Time	Method
To further explore the current suspected HNC pathway and the language used when discussing symptoms.	September 2022 - August 2023	To understand how clinicians decide subsequent steps for patients referred with suspected HNC, the language patients and clinicians use to describe symptoms and patients' and clinicians' views and experiences of the current diagnostic process for HNC. with a focus on what would work for EVEREST-HN study.

Trial Locations

Locations (4)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

Luton & Dunstable University Hospital; 🇬🇧 Luton, United Kingdom

Oxford NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom