Protocol for a feasibility study incorporating a randomised pilot trial with an embedded process evaluation and feasibility economic analysis of ThinkCancer!: a primary care intervention to expedite cancer diagnosis in Wales

Published on Apr 21, 2021in Pilot and Feasibility Studies
· DOI :10.1186/S40814-021-00834-Y
Stefanie Disbeschl1
Estimated H-index: 1
(Bangor University),
Alun Wyn Surgey2
Estimated H-index: 2
(Bangor University)
+ 12 AuthorsClare Wilkinson37
Estimated H-index: 37
(Bangor University)
Source
Abstract
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 .
References45
Newest
#1Alun Wyn Surgey (Bangor University)H-Index: 2
#2Stefanie Disbeschl (Bangor University)H-Index: 1
Last. Clare Wilkinson (Bangor University)H-Index: 37
view all 18 authors...
ABSTRACT Background Relatively 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. Methods A review of reviews, survey, discrete choice expe...
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#1Claire Friedemann Smith (University of Oxford)H-Index: 10
#2Sarah Drew (LSE: London School of Economics and Political Science)H-Index: 1
Last. Brian D Nicholson (University of Oxford)H-Index: 17
view all 4 authors...
Background Growing evidence for the role of GPs’ gut feelings in cancer diagnosis raises questions about their origin and role in clinical practice. Aim To explore the origins of GPs’ gut feelings for cancer, their use, and their diagnostic utility. Design and setting Systematic review and meta-analysis of international research on GPs’ gut feelings in primary care. Method Six databases were searched from inception to July 2019, and internet searches were conducted. A segregated method was used ...
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Clinical professionals are at the forefront of learning and innovation about, and sparked by, the pandemic. Mun-Keat Looi and Rebecca Coombes report from the first virtual Risky Business conference, held on 2 June
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#1Alvina G. Lai (UCL: University College London)H-Index: 17
#2Laura Pasea (UCL: University College London)H-Index: 10
Last. Harry Hemingway (UCL: University College London)H-Index: 89
view all 24 authors...
Background: Cancer and multiple non-cancer conditions are considered by the Centers for Disease Control and Prevention (CDC) as high risk conditions in the COVID-19 emergency. Professional societies have recommended changes in cancer service provision to minimize COVID-19 risks to cancer patients and health care workers. However, we do not know the extent to which cancer patients, in whom multi-morbidity is common, may be at higher overall risk of mortality as a net result of multiple factors in...
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#1Daniel Jones (University of Leeds)H-Index: 8
#2Richard D Neal (University of Leeds)H-Index: 52
Last. Katherine Emma Brain (Cardiff University)H-Index: 32
view all 6 authors...
The entire landscape of cancer management in primary care, from case identification to the management of people living with and beyond cancer, is evolving rapidly in the face of the coronavirus disease 2019 (COVID-19) pandemic.1 In a climate of fear and mandated avoidance of all but essential clinical services, delays in patient, population, and health-care system responses to suspected cancer symptoms seem inevitable.
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#1James Spicer ('KCL': King's College London)H-Index: 56
Last. Sophie Papa ('KCL': King's College London)H-Index: 18
view all 3 authors...
Health-care services are rapidly transforming their organization and workforce in response to the coronavirus disease 2019 (COVID-19) pandemic. These changes, and a desire to mitigate infection risk, are having profound effects on other vital aspects of care, including the care of patients with cancer. Difficult decisions are being made regarding the prioritization of both active treatments and palliative care, despite limited evidence that cancer is an independent risk factor for infection and ...
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#1Alice Tompson (University of Oxford)H-Index: 9
#2Brian D Nicholson (University of Oxford)H-Index: 17
Last. Clare Bankhead (University of Oxford)H-Index: 33
view all 5 authors...
Background Safety netting is a diagnostic strategy that involves monitoring patients with symptoms possibly indicative of serious illness, such as cancer, until they are resolved. Optimising safety-netting practice in primary care has been proposed to improve quality of care and clinical outcomes. Introducing guidelines is a potential means to achieve this. Aim To seek the insight of frontline GPs regarding proposed safety-netting guidelines for suspected cancer in UK primary care. Design and se...
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#1Jane Heyhoe (National Health Service)H-Index: 8
#2Caroline ReynoldsH-Index: 8
Last. Rebecca Lawton (University of Leeds)H-Index: 61
view all 3 authors...
Background Diagnosing cancer earlier broadens treatment options and improves survival outcomes. When symptoms do not indicate a cancer diagnosis referral, evidence suggests patients could play an important role in achieving a faster cancer diagnosis by assisting with symptom follow-up and review. Little is known about how to engage patients in diagnosis and what a safety-netting intervention involving patients in primary care might entail. Aim Stage 1 assessed components considered important for...
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#2Emma McIntosh (Glas.: University of Glasgow)H-Index: 27
In today's world of scare resources, determining the optimal allocation of funds to preventive health care interventions (PHIs) is a challenge. The upfront investments needed must be viewed as long term projects, the benefits of which we will experience in the future. The long term positive change to PHIs from economic investment can be seen across multiple sectors such as health care, education, employment and beyond. Applied Health Economics for Public Health Practice and Research is the fifth...
#1Daniel Jones (Hull York Medical School)H-Index: 8
#2Laurie Dunn (Hull York Medical School)H-Index: 2
Last. Una Macleod (Hull York Medical School)H-Index: 30
view all 4 authors...
Background Ensuring patient safety is vital in primary care. One mechanism to increase patient safety is through a practice known as safety netting. Safety netting is widely recommended in national guidelines; however, a variety of definitions exist with no consensus on when safety netting should be used and what advice or actions it should contain. Aim This study aimed to identify different definitions of safety netting to provide conceptual clarity and propose a common approach to safety netti...
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Cited By1
Newest
#1Richard D Neal (University of Exeter)H-Index: 1
#2Lesley Smith (University of Leeds)H-Index: 7
Urgent GP cancer referrals, often referred to as 2-week wait (2WW) referrals in England (with equivalent processes in the devolved nations), have changed the landscape of cancer diagnosis in the UK. The data presented by Round et al ,1 demonstrate this starkly: referrals have increased hugely over the past decade and the detection rate (DR; the percentage of new cancer cases treated resulting from a 2WW referral) has increased from 41% to 52% over this period. This is especially good news as pat...
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