Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer—the SiP study protocol
Date
2016-08-04Author
Wells, Mary
King, Emma
Toft, Kate
MacAulay, Fiona
Patterson, Joanne
Dougall, Nadine
Hulbert-Williams, Nick
Boa, Sally
Slaven, Eleanor
Cowie, Julie
McGarva, John
Niblock, Patricia Gail
Philp, Julie
Roe, Justin
Metadata
Show full item recordCitation
Wells, M., King, E., Toft, K., MacAulay, F., Patterson, J., Dougall, N., Hulbert-Williams, N., Boa, S., Slaven, E., Cowie, J., McGarva, J., Niblock, P.G., Philp, J. and Roe, J. (2016) 'Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer—the SiP study protocol', Pilot and Feasibility Studies, 2, article no. 40.
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/design: 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.
Discussion: 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.
Trial registration: NCRI portfolio, 18192 & 20259