Swallowing Intervention Package (SiP) Phase 2

• Research type

  Research Study

• Full title

  Improving quality of life and swallowing function in patients with head and neck cancer: Development and feasibility of a Swallowing Intervention Package (SiP) - Phase 2

• IRAS ID

  178830

• Contact name

  Mary Wells

• Contact email

  mary.wells@stir.ac.uk

• Sponsor organisation

  University of Stirling

• Clinicaltrials.gov Identifier

  NRS14/ON593, NRS reference for Phase 1

• Duration of Study in the UK

  1 years, 5 months, 28 days

• Research summary

  Due to increasing incidence, more intensive treatment and improved survival, a growing number of head and neck cancer (HNC) survivors experience long­-term swallowing difficulties, profoundly affecting eating/drinking, increasing dependence on feeding tubes, increasing the risk of aspiration (food/fluid entering the airway) and significantly reducing quality of life. Some evidence suggests that swallowing exercises can improve outcomes in HNC patients undergoing combined treatment with chemo­radiotherapy. However, many questions remain about the timing, selection and duration of exercises as well as their practicality and feasibility in the UK.
  We are developing a practical Swallowing Intervention Package(SIP), in partnership with patients and speech and language therapists. We are currently undertaking Phase 1 of the study, which includes focus groups and consensus workshops with patients, carers and health care professionals, in order to develop the intervention. This application relates to the second phase. Phase 2 will involve a feasibility study using qualitative and quantitative methods to examine treatment fidelity, adherence to and impact of the SIP on quality of life, swallowing outcomes and service use, in order to inform a future trial. A combination of patient-reported outcome measures (PROMs), adherence measures and clinical swallowing assessments will be used prior to intervention (baseline), 3 and 6 months post treatment (follow-up x 2). Analysis of the collected data will inform the best primary outcome measure and sample size calculation for a future trial.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  15/ES/0106

• Date of REC Opinion

  21 Aug 2015

• REC opinion

  Further Information Favourable Opinion