SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer

Govender et al. BMC Cancer (2020) 20:360 https://doi.org/10.1186/s12885-020-06877-3 RESEARCH ARTICLE Open Access SIP SMART: a parallel group randomised feasibility trial of a tailored pre-treatment swallowing intervention package compared with usual care for patients with head and neck cancer Roganie Govender1* , Christina H. Smith2, Helen Barratt3, Benjamin Gardner4 and Stuart A. Taylor5 Abstract Background: Dysphagia or difficulty in swallowing affects quality of life for most patients with head and neck cancer. SIP SMART – [Swallowing Intervention Package: Self-Monitoring, Assessment, Rehabilitation Training] aims to improve post-treatment swallowing outcomes through a targeted and tailored pre-treatment intervention. This feasibility study assessed 1) recruitment and retention, 2) patient acceptability of randomisation and participation, 3) patient adherence, and 4) sought to identify a suitable primary outcome for a definitive trial, including sample size estimation. Methods: This two-arm parallel group non-blinded randomised feasibility trial took place within a head and neck centre at a teaching hospital in London, UK. Patients newly diagnosed with stage III/IV head and neck cancer were recruited and underwent 6-month follow-up. Patients were randomised to SIP-SMART or usual care via an online webbased system. SIP SMART comprised two 45-min consultations including a baseline clinical and instrumental swallowing assessment, relevant educational information, targeted swallowing exercises, and specific behaviour change strategies to increase exercise adherence. Usual care comprised a single session including a baseline clinical assessment and generic information about the likely impact of treatment on swallowing. Results: A total of 106 patients were identified at pre-screening, 70 were assessed for eligibility. Twenty-six patients did not meet eligibility criteria [0.37, 95% CI 0.27 to 0.49]. Five of 44 [0.11, 95% CI 0.05 to 0.24] eligible patients were not approached by researchers during clinic. Seven [0.18, 95% CI 0.08 to 0.33] of the 39 approached declined participation. Target recruitment (32 consented patients) was achieved within the timeframe. At 6-months 29/32 [0.91, 95% CI 0.76 to 0.97] patients remained in the trial. Acceptability of randomisation and participation in the intervention was favourable, and adherence to the exercises exceeded the pre-defined 35% minimum criterion. The MD Anderson Dysphagia Inventory swallow related quality of life measure was selected as the most suitable primary outcome for sample size estimation. No adverse effects arose from the intervention, or study participation. (Continued on next page) * Correspondence: ; 1 Research Department of Behavioural Science & Health, University College London and Head & Neck Cancer Centre, University College London Hospital, 250 Euston Road, Ground floor Central, London NW1 2PQ, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data. Govender et al. BMC Cancer (2020) 20:360 Page 2 of 13 (Continued from previous page) Conclusions: A definitive trial of the SIP SMART intervention compared to usual care is feasible and can be undertaken with patients with head and neck cancer treated within the NHS. Trial registration: ISRCTN40215425, registered retrospectively. Keywords: Head and neck cancer, Swallowing, Dysphagia, Behaviour change intervention, Feasibility study, Randomised controlled trial Background Difficulty in swallowing (dysphagia) affects approximately 60% of patients with head and neck cancer (HNC) at the time of diagnosis [1], and almost all patients who undergo treatment during their cancer care pathway [2]. Both the tumour itself, and treatments such as surgery and chemo-radiation therapy have a negative impact on eating, drinking and swallowing [3–5]. Swallowing is a highly coordinated muscular activity that is generally performed at a sub-conscious level by most people unless the mechanism is disrupted causing dysphagia. Swallowing may also be described as a submaximal process, in that the force required to swallow food is less than the capability of the swallowing muscles [6]. Given that HNC and its treatments are known to result in dysphagia, there may be scope for optimising swallowing physiology through prophylactic exercise interventions that increase the strength and range of movement of swallowing muscles. It seems plausible that exercises may increase physiological reserve and possibly delay or even avoid difficulties with swallowing both during and after cancer treatments. However, a Cochrane systematic review of prophylactic swallowing exercises reported uncertainty around their efficacy [7]. The Cochrane review called for new studies that addressed inconsistencies in the current literature, notably choice of swallowing exercise protocols, methods to address poor patient adherence, and variability in the type and timing of outcome measures, all of which undermine assessment of efficacy [7]. We have developed a new pre-treatment intervention (SIP SMART: Swallowing Intervention Package- Self Monitoring, Assessment, Rehabilitation Training), designed to address some of the shortcomings of previous clinical trials. The intervention development was informed by a series of studies including: a systematic review to identify behavioural strategies that could potentially promote patient adherence to swallowing exercises [8]; an in-depth interview study to establish patient reported barriers and facilitators to exercise adherence [9]; and a think-aloud study to explore the potential use of video-animation to improve how information about swallowing and dysphagia is conveyed to patients [10]. Further detail about the systematic development of SIP SMART using the Medical Research Council framework for the development and evaluation of complex interventions [11] and the Behaviour Chang (...truncated)