• The Finding My Way UK Clinical Trial: Adaptation report and protocol for a replication randomised controlled efficacy trial of a web-based psychological programme to support cancer survivors

      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; et al. (JMIR, 2021-07-12)
      Background: 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. Online interventions demonstrate good efficacy in addressing these concerns and are more accessible than face to face interventions. Finding My Way is an online, psycho-educational and cognitive behaviour therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated Finding My Way to be acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life, whilst leading to cost-savings through health-resource use reduction. Objectives: Our study will adapt the Australian Finding My Way website for a UK cancer care context, and then undertake a single-blinded, randomised controlled trial (RCT) of Finding My Way UK against a treatment-as-usual waitlist control. Methods: As much as possible, our trial design replicates the existing Australian RCT of Finding My Way. 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: (i) have been diagnosed with cancer of any type in the last six months, (ii) have received anti-cancer treatment with curative intent, (iii) be over 16 years of age, (iv) be proficient in English and (v) have access to the internet and an active email address. Participants will be identified and recruited through the NIHR Clinical Research Network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report online questionnaire at baseline, mid-treatment, post-treatment and both three- and six-month follow-up. Quantitative data will be analysed using intention-to-treat Mixed-Model Repeated Measures analysis. Embedded semi-structured qualitative interviews will probe engagement with, and experiences of using, Finding My Way UK and suggestions for future improvements. Results: Website adaptation work was completed in January 2021. A panel of cancer survivors and healthcare professionals provided feedback on the test version of Finding My Way UK. Feedback was positive overall, though 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. Conclusions: Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literatures, and especially in different geographical settings. Prior to replicating the Finding My Way trial in the UK setting, some content updating was required. If Finding My Way UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for UK cancer survivors.