Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer—the SiP study protocol

Wells et al. Pilot and Feasibility Studies (2016) 2:40 DOI 10.1186/s40814-016-0079-6 STUDY PROTOCOL Open Access Development and feasibility of a Swallowing intervention Package (SiP) for patients receiving radiotherapy treatment for head and neck cancer—the SiP study protocol Mary Wells1* , Emma King1, Kate Toft2, Fiona MacAulay3, Joanne Patterson4, Nadine Dougall5, Nick Hulbert-Williams6, Sally Boa7, Eleanor Slaven8, Julie Cowie9, John McGarva10, Patricia Gail Niblock11, Julie Philp12 and Justin Roe13 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. (Continued on next page) * Correspondence: 1 NMAHP Research Unit, University of Stirling, Stirling, UK Full list of author information is available at the end of the article © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wells et al. Pilot and Feasibility Studies (2016) 2:40 Page 2 of 13 (Continued from previous page) 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 Keywords: Dysphagia, Cancer, Head and neck, Intervention, Exercise, Rehabilitation, Study protocol Background Head and neck cancer (HNC) is the sixth most common cancer worldwide [1]. Currently, there are more than 62,000 people living with head and neck cancer in the UK [2]. In Scotland, where incidence rates are significantly higher than the rest of the UK, a 37 % rise is predicted in the next 10 years [3]. Patients are surviving longer and, due to human papillomavirus, are younger at diagnosis. The functional, psychological and social consequences of HNC cancer and its treatment can be severe and chronic. Treatment includes a combination of surgery, radiotherapy and/or chemotherapy, and the side effects of these can interfere with some of the most fundamental aspects of daily living, including eating, drinking, communication and appearance. Improved survival has been achieved at the expense of increased morbidity, especially in relation to swallowing problems or ‘dysphagia’ [4]. Dysphagia affects up to two thirds of patients undergoing combined chemoradiotherapy (CRT) [5]. Patients report major deterioration in their swallowing, and little evidence of recovery over time, with younger survivors reporting the most severe problems [6]. Early side effects of CRT1 include pain, mucositis (inflammation of the mucous membranes) and xerostomia (dry mouth). Late effects include fibrosis (scarring) of the soft tissues, affecting the safety and efficiency of swallowing [7, 8]. Aspiration rates (food or fluid entering the airway) are high (≥60 %), leading to frequent hospitalisation for chest infection, pneumonia and even death [5, 8]. The effects of CRT contribute to significant weight loss, and 50–70 % of patients require a feeding tube during or after treatment [9]. Tube dependency reduces the need to swallow, so increasing the likelihood of fibrosis of the muscles involved in swallowing, and in the long-term, ‘disuse atrophy’, sometimes leading to complete inability to swallow. Swallowing difficulties have a significant negative emotional and physical impact on social eating, return to work and everyday quality of life [7]. Recent reviews [10, 11] suggest that prophylactic swallowing exercises may improve a range of short- and long-term outcomes, as they increase the blood flow to muscles, reducing or preventing fibrosis, and maintaining the range and speed of swallowing movements. However, not all trials have had positive results [12–14], and a number of questions remain, including the optimal timing, selection and duration of exercises, the achievement of intervention fidelity and, importantly, the support necessary to improve adherence [10]. Only 13–14 % of participants practise swallowing exercises as recommended [15, 16]. An unpublished study found that patients with high levels of pain during treatment struggled with performing regular exercises and that it was difficult to focus on preventative exercises in the context of facing a potentially life-limiting disease. Furthermore, the intervention was not seen as integral to their overall care [17]. There is, however, evidence that (...truncated)