Govender Roganie, Smith Christina H, Gardner Benjamin, Barratt Helen, Taylor Stuart A
University College London Hospital, Head & Neck Cancer Centre, London, UK.
Department of Behavioural Science & Health, University College London, London, UK.
BMJ Open. 2017 Mar 27;7(3):e014167. doi: 10.1136/bmjopen-2016-014167.
The incidence of head and neck cancer (HNC) in the UK is rising, with an average of 31 people diagnosed daily. Patients affected by HNC suffer significant short-term and long-term post-treatment morbidity as a result of dysphagia, which affects daily functioning and quality of life (QOL). Pretreatment swallowing exercises may provide additional benefit over standard rehabilitation in managing dysphagia after primary HNC treatments, but uncertainty about their effectiveness persists. This study was preceded by an intervention development phase to produce an optimised swallowing intervention package (SIP). The aim of the current study is to assess the feasibility of this new intervention and research processes within a National Health Service (NHS) setting.
A two-arm non-blinded randomised controlled feasibility study will be carried out at one tertiary referral NHS centre providing specialist services in HNC. Patients newly diagnosed with stage III and IV disease undergoing planned surgery and/or chemoradiation treatments will be eligible. The SIP will be delivered pre treatment, and a range of swallowing-related and QOL measures will be collected at baseline, 1, 3 and 6 months post-treatment. Outcomes will test the feasibility of a future randomised controlled trial (RCT), detailing rate of recruitment and patient acceptance to participation and randomisation. Salient information relating to protocol implementation will be collated and study material such as the case report form will be tested. A range of candidate outcome measures will be examined for suitability in a larger RCT.
Ethical approval was obtained from an NHS Research Ethics Committee. Findings will be published open access in a peer-reviewed journal, and presented at relevant conferences and research meetings.
ISRCTN40215425; Pre-results.
英国头颈癌（HNC）的发病率正在上升，平均每天有31人被确诊。由于吞咽困难，HNC患者在治疗后会遭受严重的短期和长期发病，这会影响日常功能和生活质量（QOL）。在原发性HNC治疗后，预处理吞咽练习在管理吞咽困难方面可能比标准康复提供更多益处，但关于其有效性仍存在不确定性。本研究之前有一个干预开发阶段，以制定一个优化的吞咽干预方案（SIP）。本研究的目的是评估这种新干预措施和研究过程在国民健康服务（NHS）环境中的可行性。
将在一个提供HNC专科服务 的三级转诊NHS中心进行一项双臂非盲随机对照可行性研究。新诊断为III期和IV期疾病且正在接受计划手术和/或放化疗的患者将符合条件。SIP将在治疗前提供，并且将在基线、治疗后1、3和6个月收集一系列与吞咽相关的和生活质量测量数据。结果将测试未来随机对照试验（RCT）的可行性，详细说明招募率以及患者对参与和随机分组 的接受情况。将整理与方案实施相关的重要信息，并测试病例报告表等研究材料。将检查一系列候选结局指标在更大规模RCT中的适用性。
已获得NHS研究伦理委员会的伦理批准。研究结果将在同行评审期刊上以开放获取的方式发表，并在相关会议和研究会议上展示。
ISRCTN40215425；预结果。
