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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05909020

Collaborator

University of Leeds (Other)

165

Enrollment

Locations

5.5

Anticipated Duration (Months)

41.3

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: No intervention.

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 Design

Study Type:

Observational

Anticipated Enrollment :

165 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 17, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients Approximately 150 adults referred for suspected HNC will be recruited.	Other: No intervention. No intervention.
Staff Approximately 15 ENT and Maxillofacial) clinicians will be recruited.	Other: No intervention. No intervention.

Arm

Intervention/Treatment

Patients

Approximately 150 adults referred for suspected HNC will be recruited.

Other: No intervention.

No intervention.

Staff

Approximately 15 ENT and Maxillofacial) clinicians will be recruited.

Other: No intervention.

No intervention.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Leeds Teaching Hospitals NHS Trust	Leeds	United Kingdom
2	Liverpool University Hospitals NHS Foundation Trust	Liverpool	United Kingdom
3	Luton & Dunstable University Hospital	Luton	United Kingdom
4	Oxford NHS Foundation Trust	Oxford	United Kingdom

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust
University of Leeds

Investigators

Study Chair: Vinidh Paleri, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT05909020

Other Study ID Numbers:

CCR5683

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jun 18, 2023