Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov NCT04823559.
BackgroundRelatively poor UK cancer outcomes are blamed upon late diagnosis. Despite most cancer patients presenting to their GP with symptoms, diagnostic delay remains a common theme, with many clinical and non-clinical factors responsible. Early diagnosis is key to improving outcomes and survival. This paper reports the multi-method process to design a complex intervention to improve the timely diagnosis of symptomatic cancer.MethodsA review of reviews, survey, discrete choice experiment, qualitative interviews and focus groups, all informed a realist evidence synthesis. This in turn informed the design of a complex intervention, guided by the Behaviour Change Wheel framework using a multi-step process.ResultsKey themes from the realist evidence synthesis included effective safety netting at practitioner and practice system level, increased vigilance and lowering referral thresholds. Qualitative findings explored the tensions, barriers and facilitators affecting suspected cancer referral. The Think Cancer! intervention is an educational and quality improvement workshop directed at the whole primary care team. Bespoke cancer safety netting plans and appointment of cancer champions are key components.ConclusionsThink Cancer! is a novel primary care early cancer diagnosis intervention, requiring evaluation through a cluster randomised control trial.
BackgroundRelative 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.MethodsThe 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), Two Week Wait (2WW) referral rates, conversion rates and detection rates at baseline and six 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.DiscussionThis 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.Trial registratiointended registry: clinicaltrials.gov
BackgroundCancer survival in the UK remains low compared to other Western countries including Australia, Canada and European countries. Delays in cancer diagnosis have an adverse impact on patient well-being and survival. Welsh Government outline a number of challenges with respect to earlier cancer diagnosis, including a lack of awareness of ‘red flag’ symptoms and difficulties among GPs and other healthcare professionals in identifying cancers that present with vague or non-specific symptoms. For some cancers, earlier diagnosis is associated with greater survival, better patient experience and quality of life, and lower healthcare costs. MethodsThe ThinkCancer! intervention is a complex behaviour change intervention, which aims to change the behaviours of primary care practice teams when thinking of and acting on clinical symptoms that could be cancer. From an NHS perspective, we conducted a feasibility economic analysis of the ThinkCancer! intervention. We used micro-costing methodology to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! intervention. Due to the Covid-19 pandemic, the intervention was mostly delivered remotely in a digital format. Intervention deliverers completed data collection sheets (including forms recording materials used and intervention deliverer time) and provided information on primary care staff attendance at each of the ThinkCancer! workshops. Budget impact analysis and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19. FindingsThe total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25,030. Costs per practice ranged from £431 to £2,498, with an average cost per practice of £1,311 (SD: 579.5). The potential budget impact if the intervention were to be delivered face-to-face across the 19 general practices would be £34,630. Sensitivity analysis revealed that if the intervention were to be delivered by one GP educator, the total estimated cost for face-to-face delivery would be £31,232. With the addition of one support role assisting the GP educator with the intervention delivery, the total cost of face-to-face delivery is estimated to be approximately £33,138. ConclusionsResults of this feasibility study are being used to inform a definitive economic evaluation alongside a pragmatic randomised controlled trial. Primary care interventions to expedite the diagnosis of symptomatic cancer have the potential to reduce large costs to the NHS and improve patient and carer outcomes as later stage cancer treatments are often longer, more aggressive to patients, with larger associated healthcare costs compared to earlier stage treatment. http://wicked.bangor.ac.uk/
BackgroundUK cancer survival rates are much lower compared with other high-income countries. In primary care, there are opportunities for general practitioners (GPs) and other healthcare professionals to act more quickly in response to presented symptoms that might represent cancer. ThinkCancer! is a complex behaviour change intervention aimed at primary care practice teams to improve the timely diagnosis of cancer.AimTo explore the costs of delivering the ThinkCancer! intervention to expedite cancer diagnosis in primary care.DesignFeasibility economic analysis using a micro-costing approach.SettingNineteen general practices in Wales, UK.MethodsFrom an NHS perspective, we used micro-costing methodology to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! intervention. Due to the Covid-19 pandemic, ThinkCancer! was mainly delivered remotely online in a digital format. Budget impact analysis and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19.ResultsThe total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25,030, with an average cost per practice of £1,317 (SD: 578.2). Findings from the budget impact analysis indicated a total cost of £34,630 for face-to-face delivery.ConclusionData collection methods were successful in gathering sufficient health economics data to cost the ThinkCancer! intervention. Results of this feasibility study will be used to inform a future definitive economic evaluation alongside a pragmatic randomised controlled trial.Trial registrationClinicalTrials.govNCT04823559.
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