Core Outcome Measures in Effectiveness Trials

Head and neck cancer: defining core outcome sets for clinical trials

General Information

Summary:
Approximately 7000 new cases of Squamous Cell Carcinoma of the Head and Neck (SCCHN) are diagnosed annually in the UK. However 5 year survival rates remain stubbornly resistant to improvement, remaining at approximately 60% over the last three decades. There are wide variations in tumour behaviour, and in response to treatment. There is also a wide variation in early and late adverse events experienced by patients undergoing treatment. Long-term functional deficits in swallowing function, speech and cosmesis are commonplace in treatment survivors.

Whilst it is common for SCCHN to be considered as a homogeneous tumour group, wide variations in tumour behaviour and response to treatment are known to occur between tumours originating from different anatomical sub-sites and between apparently similar tumours originating at the same site. It is these issues of biological heterogeneity, incidence of post-treatment functional deficits and relatively small numbers which provide particular challenges when deciding on outcomes for clinical trials for patients with SCCHN.

Currently, core outcome measures, whether surrogate, functional, quality of life or survival related, do not exist, making it particularly difficult to identify optimal treatment regimens when comparing data from competing trials. It is therefore with a matter of some urgency that attempts are made to include all relevant stakeholders to define such measures.

Study protocol: http://www.trialsjournal.com/content/15/1/168
DOI: 10.1186/1745-6215-15-168


Contributors:
PhD supervisors: Dr Terry Jones and Dr Catrin Tudor-Smith, University of Liverpool

Research fellow: Aoife Waters, University of Liverpool

Further Study Information

Current Stage:
Ongoing
Date:
August 2011 - August 2014
Funding source(s):
The Medical Research Council

Health Area

Disease Category
Cancer
Ear, nose, & throat

Disease Name
Head and neck cancer

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Chemotherapy
Radiotherapy
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

Systematic review to summarise outcomes in head and neck cancer clinical trials and a multiperspective Delphi consensus project.

Will involve:

Patients and their Carers.

Members of the Head and Neck Cancer Multi-disciplinary team including Head and Neck Oncologists (Surgical and non-surgical), Head and Neck Surgeons, ENT and Specialist Head and Neck Cancer Nurses, Head and Neck Speech and Language Therapists, Dieticians, Psychologists and allied dental specialists.

Cochrane ENT group
Liverpool Cancer Research UK


Stakeholders Involved

Charities
Clinical experts
Consumers (caregivers)
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research

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