Hulbert-Williams Nicholas J, Leslie Monica, Hulbert-Williams Lee, Koczwara Bogda, Watson Eila K, Hall Peter S, Ashley Laura, Coulson Neil S, Jackson Richard, Millington Sue, Beatty Lisa
Centre for Contextual Behavioural Science, School of Psychology, University of Chester, Chester, United Kingdom.
College of Medicine and Public Health, Flinders University, Adelaide, Australia.
JMIR Res Protoc. 2021 Sep 20;10(9):e31976. doi: 10.2196/31976.
Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction.
This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control.
To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements.
The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023.
Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom.
International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31976.
癌症幸存者经常报告一系列未得到满足的心理和支持性护理需求；这些需求在治疗结束后往往仍会持续，并预示着心理困扰和健康相关生活质量不佳。基于网络的干预措施在解决这些问题方面显示出良好的效果，并且比面对面干预更容易获得。“找到我的路”（FMW）是澳大利亚为癌症幸存者开发的一种基于网络的、心理教育和认知行为疗法干预措施。先前的试验表明，FMW是可接受的、高度依从的，并且在降低困扰对生活质量的影响方面是有效的，同时通过减少卫生资源使用实现了成本节约。
本研究旨在使澳大利亚的FMW网站适用于英国的癌症护理环境，然后对英国版FMW与常规治疗等待名单对照进行单盲随机对照试验。
在一定程度上，我们的试验设计复制了现有的澳大利亚FMW随机对照试验。在对网络资源进行全面改编后，我们将从英格兰西北部和北威尔士的临床站点招募294名参与者（每个研究组147名）。参与者在过去6个月内被诊断患有任何类型的癌症，接受了旨在治愈的抗癌治疗，年龄≥16岁，精通英语，能够访问互联网并拥有有效的电子邮件地址。参与者将通过英国国家卫生研究院临床研究网络进行识别和招募。将在基线、治疗中期、治疗后以及3个月和6个月随访时使用基于网络的自我报告问卷收集困扰、生活质量和卫生经济结果的测量数据。定量数据将使用意向性治疗混合模型重复测量分析进行分析。嵌入式半结构化定性访谈将探讨对英国版FMW的参与情况、使用体验以及对未来改进的建议。
网站改编工作于2021年1月完成。一组癌症幸存者和医疗保健专业人员对英国版FMW的测试版本提供了反馈。总体反馈是积极的，不过对网站导航、包容性（内容）、术语以及“改善沟通、性与亲密关系”内容的措辞进行了一些小的更新。临床试验的招募工作于2021年4月开始。我们计划在2023年年中报告研究结果。
复制研究是科学过程的一个重要方面，特别是在心理学和临床试验文献中，尤其是在不同的地理环境中。在英国环境中复制FMW试验之前，需要进行内容更新。如果英国版FMW现在能够复制澳大利亚的研究结果，我们将为英国的癌症幸存者确定一种新颖且具有成本效益的心理社会护理提供方法。
国际标准随机对照试验编号（ISRCTN）14317248；https://www.isrctn.com/ISRCTN14317248。
国际注册报告识别码（IRRID）：DERR1-10.2196/31976。
