Disbeschl Stefanie, Surgey Alun, Roberts Jessica L, Hendry Annie, Lewis Ruth, Goulden Nia, Hoare Zoe, Williams Nefyn, Anthony Bethany Fern, Edwards Rhiannon Tudor, Law Rebecca-Jane, Hiscock Julia, Carson-Stevens Andrew, Neal Richard D, Wilkinson Clare
North Wales Centre for Primary Care Research (NWCPCR), Bangor University, Cambrian 2, Wrexham Technology Park, Wrexham, LL13 7YP, UK.
North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, The Normal Site, Holyhead Road, Gwynedd, LL57 2PZ, UK.
Pilot Feasibility Stud. 2021 Apr 21;7(1):100. doi: 10.1186/s40814-021-00834-y.
Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer! workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! intervention for a future definitive randomised controlled trial.
The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect primary care intervals (PCI), 2-week wait (2WW) referral rates, conversion rates and detection rates at baseline and 6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation.
This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial.
ClinicalTrials.gov NCT04823559 .
与欧洲其他地区相比，英国的癌症治疗效果相对较差，主要原因是诊断延迟和转诊流程缓慢。全科医生（GPs）经常面对出现多种可能是癌症的非特异性症状的患者。安全网措施可用于通过确保对症状模糊的患者进行适当监测来管理诊断不确定性，鉴于正在进行的COVID-19大流行及其对癌症转诊的重大影响，这一点现在变得更加关键。“思考癌症！”研讨会是一项针对整个全科医疗团队的教育行为改变干预措施，旨在改进初级保健方法以确保及时诊断癌症。该研讨会将包括教学和提高认识环节、任命一名安全网冠军以及制定定制的安全网计划，并且已经进行了调整以便可以远程开展。本研究旨在评估“思考癌症！”干预措施用于未来确定性随机对照试验的可行性。
“思考癌症！”研究是一项随机、多地点可行性试验，包含嵌入式过程评估和可行性经济分析。将在威尔士招募23至30家全科医疗机构，按照2:1的比例随机分为干预组和对照组，对照组将遵循常规护理。研讨会将由一名全科医生教育工作者授课，并将在整个试验期间进行迭代调整。将通过问卷收集基线实践特征。我们还将在基线时以及随机分组后6个月收集初级保健间隔时间（PCI）、两周等待（2WW）转诊率、转化率和检出率。每次研讨会后将收集参与者反馈、研究人员反思和经济成本核算。过程评估将使用经过改编的标准化测量发展（NoMAD）问卷和定性访谈来评估实施情况。经济可行性分析将为未来的经济评估提供信息。
本研究将使我们能够测试并进一步开发一种针对全科医疗团队的新型循证复杂干预措施，以加快初级保健中癌症的诊断。本研究的结果将为未来全面的确定性III期试验的设计提供信息。
ClinicalTrials.gov NCT04823559 。
