EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem
October 2, 2023 updated by: Royal Marsden NHS Foundation Trust
EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
165
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Webb
- Phone Number: 0208 915 6666
- Email: EVEREST-HN@rmh.nhs.uk
Study Locations
-
-
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Leeds, United Kingdom
- Not yet recruiting
- Leeds Teaching Hospitals NHS Trust
-
Contact:
- Unknown Unknown
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Principal Investigator:
- James Moor
-
Liverpool, United Kingdom
- Recruiting
- Liverpool University Hospitals NHS Foundation Trust
-
Contact:
- Shirley Pringle
-
Principal Investigator:
- Katharine Davies
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Luton, United Kingdom
- Recruiting
- Luton & Dunstable University Hospital
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Contact:
- Nithin George
-
Principal Investigator:
- Chrysostomos Tornari
-
Oxford, United Kingdom
- Recruiting
- Oxford NHS Foundation Trust
-
Contact:
- Iqbal Mohammed
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Principal Investigator:
- Stuart Winter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Approximately 150 adults referred for suspected HNC will be recruited.
|
No intervention.
|
|
Staff
Approximately 15 ENT and Maxillofacial) clinicians will be recruited.
|
No intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inventory and specification for the SYmptom iNput Clinical (SYNC) system
Time Frame: September 2022 - August 2023
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To further explore the current suspected HNC pathway and the language used when discussing symptoms.
Time Frame: 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.
|
September 2022 - August 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Vinidh Paleri, Royal Marsden NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2023
Primary Completion (Estimated)
November 30, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR5683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.