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NCT05909020 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05909020
Other study ID # CCR5683
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 17, 2023
Est. completion date November 30, 2023

Study information
Verified date October 2023
Source Royal Marsden NHS Foundation Trust
Contact Sarah Webb
Phone 0208 915 6666
Email EVEREST-HN@rmh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 165
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention.
No intervention.

Locations
Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Liverpool University Hospitals NHS Foundation Trust Liverpool
United Kingdom Luton & Dunstable University Hospital Luton
United Kingdom Oxford NHS Foundation Trust Oxford

Sponsors (2)
Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inventory and specification for the SYmptom iNput Clinical (SYNC) system To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system September 2022 - August 2023
Secondary To further explore the current suspected HNC pathway and the language used when discussing symptoms. 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. September 2022 - August 2023
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