title: Improving swallowing outcomes in patients with head and neck cancer using a theory-based pretreatment swallowing intervention package: protocol for a randomised feasibility study.
abstract: The incidence of head and neck cancer (HNC) in the UK is rising, with an average of 31 people diagnosed daily. Patients affected by HNC suffer significant short-term and long-term post-treatment morbidity as a result of dysphagia, which affects daily functioning and quality of life (QOL). Pretreatment swallowing exercises may provide additional benefit over standard rehabilitation in managing dysphagia after primary HNC treatments, but uncertainty about their effectiveness persists. This study was preceded by an intervention development phase to produce an optimised swallowing intervention package (SIP). The aim of the current study is to assess the feasibility of this new intervention and research processes within a National Health Service (NHS) setting.
  
  
  
  A two-arm non-blinded randomised controlled feasibility study will be carried out at one tertiary referral NHS centre providing specialist services in HNC. Patients newly diagnosed with stage III and IV disease undergoing planned surgery and/or chemoradiation treatments will be eligible. The SIP will be delivered pre treatment, and a range of swallowing-related and QOL measures will be collected at baseline, 1, 3 and 6 months post-treatment. Outcomes will test the feasibility of a future randomised controlled trial (RCT), detailing rate of recruitment and patient acceptance to participation and randomisation. Salient information relating to protocol implementation will be collated and study material such as the case report form will be tested. A range of candidate outcome measures will be examined for suitability in a larger RCT.
  
  
  
  Ethical approval was obtained from an NHS Research Ethics Committee. Findings will be published open access in a peer-reviewed journal, and presented at relevant conferences and research meetings.
  
  
  
  ISRCTN40215425; Pre-results.
authors.affiliation: University College London Hospital, Head & Neck Cancer Centre, London, UK.|Department of Behavioural Science & Health, University College London, London, UK.
authors.forename: Roganie
authors.identifier: 0000-0003-2249-434X
authors.initials: R
authors.lastname: Govender
authors.affiliation: Division of Psychology & Language Sciences, University College London, London, UK.
authors.forename: Christina H
authors.initials: CH
authors.lastname: Smith
authors.affiliation: Department of Behavioural Science & Health, University College London, London, UK.|Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), Kings College London, London, UK.
authors.forename: Benjamin
authors.identifier: 0000-0003-1223-5934
authors.initials: B
authors.lastname: Gardner
authors.affiliation: Department of Applied Health Research, NIHR CLAHRC North Thames, University College London, London, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Barratt
authors.affiliation: Centre for Medical Imaging, University College London, London, UK.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Taylor
mesh_terms: D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects; D002985:Clinical Protocols; D003680:Deglutition Disorders / Q000503:physiopathology / Q000534:rehabilitation* / Q000628:therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000503:physiopathology / Q000534:rehabilitation* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D020247:Myofunctional Therapy / Q000379:methods; D011788:Quality of Life; D016896:Treatment Outcome; D006113:United Kingdom
keywords: behaviour change techniques; dysphagia; feasibility study; head and neck cancer; swallowing exercises