title: Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer-the SiP study protocol.
abstract: BACKGROUND
  Head and neck cancer (HNC) is the sixth most common cancer worldwide, and the functional, psychological and social consequences of HNC cancer and its treatment can be severe and chronic. Dysphagia (swallowing problems) affects up to two thirds of patients undergoing combined chemoradiotherapy. Recent reviews suggest that prophylactic swallowing exercises may improve a range of short- and long-term outcomes; however, the importance of psychological and behavioural factors on adherence to swallowing exercises has not been adequately studied. This study aims to develop and test the feasibility of a Swallowing intervention Package (SiP) designed in partnership with patients, speech and language therapists (SLTs) and other members of the head and neck multi-disciplinary team (MDT), for patients undergoing chemoradiotherapy (CRT) or radiotherapy (RT) for head and neck cancer.
  
  
  METHODS
  This feasibility study uses quantitative and qualitative research methods, within a quasi-experimental design, to assess whether patients will tolerate and adhere to the SiP intervention, which aspects of the intervention can be implemented and which cannot, whether treatment fidelity can be achieved across different contexts, whether study processes and outcome measures will be feasible and acceptable and to what extent the intervention is likely to have an impact on swallowing dysfunction and quality of life. Patients are being recruited from five sites in Scotland and England (three interventions and two usual care). The SLT based in the relevant intervention centre teaches the exercise programme and provides supporting materials. A combination of patient-reported outcome measures (PROMs), adherence measures and clinical swallowing assessments are used prior to intervention (baseline), at the end of treatment, 3 and 6 months post-treatment.
  
  
  CONCLUSIONS
  This collaborative study has taken a unique approach to the development of a patient-centred and evidence-based swallowing intervention. The introduction of an e-SiP app provides an exploration of the use of technology in delivering this intervention. The study provides an opportunity to examine the feasibility of delivering and participating in a supported swallowing intervention across several different NHS sites and will provide the evidence needed to refine intervention and study processes for a future trial.
  
  
  BACKGROUND
  NCRI portfolio, 18192 & 20259.
authors.affiliation: NMAHP Research Unit, University of Stirling, Stirling, UK.
authors.forename: Mary
authors.identifier: 0000-0001-5789-2773
authors.initials: M
authors.lastname: Wells
authors.affiliation: NMAHP Research Unit, University of Stirling, Stirling, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: King
authors.affiliation: NHS Lothian, Edinburgh, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Toft
authors.affiliation: NHS Tayside, Dundee, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: MacAulay
authors.affiliation: City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Patterson
authors.affiliation: NMAHP Research Unit, University of Stirling, Stirling, UK.
authors.forename: Nadine
authors.initials: N
authors.lastname: Dougall
authors.affiliation: Department of Psychology, University of Chester, Chester, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Hulbert-Williams
authors.affiliation: Strathcarron Hospice, Denny, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Boa
authors.affiliation: NHS Greater Glasgow and Clyde, Glasgow, UK.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Slaven
authors.affiliation: Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Cowie
authors.affiliation: NHS Forth Valley, Larbert, UK.
authors.forename: John
authors.initials: J
authors.lastname: McGarva
authors.affiliation: NHS Tayside, Dundee, UK.
authors.forename: Patricia Gail
authors.initials: PG
authors.lastname: Niblock
authors.affiliation: NHS Fife, Dunfermline, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Philp
authors.affiliation: The Royal Marsden NHS Foundation Trust, London, UK.
authors.forename: Justin
authors.initials: J
authors.lastname: Roe
keywords: Cancer; Dysphagia; Exercise; Head and neck; Intervention; Rehabilitation; Study protocol