The Man Van Project: An Evaluation of the Effectiveness of a Mobile Outreach Screening Clinic Model for Earlier Detection of Prostate Cancer and Other Male Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Detection rates of other diseases
研究概览
简要总结
National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor.
The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project.
Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important).
The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider.
Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer.
The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways.
We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van.
The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer.
详细描述
Background
Early intervention is potentially lifesaving for a range of conditions. A key cause of death from cancer and other causes is late presentation and there are key barriers to early access such as low education levels, difficult access to primary care (for example due to anti-social working hours) as well as lack of knowledge of relevant symptoms that might trigger referral and investigation. The Man Van project seeks to address some of these reasons for late presentation and started with an initial focus on prostate cancer. The project has now broadened to include a range of conditions that are major causes of mortality and morbidity in men such as heart and liver disease, other urological cancers (penile, testicular, bladder, kidney). The Man Van clinics will be focused on populations at risk of delayed presentation to healthcare systems such as men in manual or low skill jobs and workplaces with high numbers of black and ethnic minority employees.
Prostate cancer is the most common cancer in men in the United Kingdom (UK), with over 50,000 new cases diagnosed and 15,000 lives lost to prostate cancer in the UK each year 1. This is of particular concern for black African and African Caribbean men who carry a 1 in 4 risk of developing prostate cancer, and for men with a family history of the disease. Another challenge is that, typically, men tend to approach their GP for men's health issues when symptoms are severe. Around 20-25% of men with prostate cancer still present to A&E with retention. At this late-stage treatment is less likely to be successful and certainly will carry more morbidity for the patient and cost for the health care system. The recent COVID-19 pandemic has further exacerbated this issue with routine referrals to cancer diagnostics clinics dropping by around a third (in house data, Royal Marsden Hospital), suggesting a growing reservoir of un-diagnosed cancer in the community.
Till date there is no consensus on the modality of prostate cancer screening, but most studies have focussed on PSA as a screening tool, with MRI scanning and biopsies as adjuncts to this. PSA itself has a controversial history in screening for prostate cancer with studies showing differing results. A key issue in using PSA as a screening tool comes from the definition of what a 'normal' PSA is. PSA increases with age and with benign growth of the prostate but can also be elevated in urinary tract infections or prostatic inflammation. Oesterling's age specific PSA ranges from 1993 are still in use today. Prostate cancer is of course another cause of PSA elevation. Having a higher PSA threshold for investigation increases the positive predictive value for detecting prostate cancer but lowers the negative predictive value, and the reverse is true as well. A study by Gerstenbluth documented a positive predictive value of 98.5% for PSA in detecting prostate cancer with a PSA of 50ng/ml or above.
The evidence for screening is also controversial resulting in differing guidance around the world. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial from the USA looked at systematic vs opportunistic screening in over 76000 men. Using a PSA threshold of over 4 and 7-10 years of follow-up no significant difference in mortality from prostate cancer was found between the screened and non-screened arms. However, the study had high rates of contamination between the two groups with an estimated 74% of the control group subject to at least one routine PSA test during the trial (95% in the intervention arm) and around 50% of men in the control group tested each year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Any patient having a PSA and/or an HbA1c test as part of a Man Van work up, or via the our rapid diagnostics clinic.
- •Inclusion Criteria: Any patient attending the Man Van for an assessment.
- •Inclusion Criteria: Any patient attending the Man Van for an assessment.
- •Inclusion Criteria: Any patient attending the Man Van for an assessment and able to provide saliva samples.
- •Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide blood/saliva samples.
- •MV MV-UctDNA
- •Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to provide urine samples.
- •Inclusion criteria:
- •Aged > 18 and over (on date of invitation to participate)
- •Works for healthcare organisation, other stakeholder or professional or potential man van patient who was not seen or relative of a Man Van patient/potential patient
- •Exclusion criteria:
- •Man van patient who has attended appointment
- •Inclusion criteria:
- •Healthcare Professionals
- •Aged > 18 and over (on date of invitation to participate)
- •Speaks English
- •Works within the UK
- •Profession: GPs, Practice Staff (Nurses, Physician Assistants and Associates
- •Healthcare assistants)
- •Experienced in adopting new tests and guidelines into practice.
- •Experienced in detecting, managing, and referring symptoms and asymptomatic patients with symptoms of prostate, pancreatic, GI cancer and/or are at an increased risk of developing these cancers.
- •Aged > 18 and over (on date of invitation to participate)
- •Speaks English
- •Lives in the UK
- •Patients with direct and in-direct experience with prostate, pancreatic, GI cancers.
- •Patients at an increased risk of developing prostate, pancreatic, GI cancer in accordance with known risk factors, which includes age, smoking, being overweight or obese, family history and genetic factors, pancreatitis, and diabetes.
- •Other key stakeholders/professionals
- •Aged > 18 and over (on date of invitation to participate)
- •Speak English
- •Works within the UK
- •Professions: medical devices and biomedical researchers, scientists, representatives for major regulatory and funding bodies
- •Knowledgeable of Early Detection initiatives (tests, outreach programes)
- •Exclusion criteria:
- •Individuals who are unwilling to take part in the study.
- •Individuals with no experience in adopting new cancer tests and guidelines into practice.
- •Individuals with no experience in in detecting, managing, and referring patients with symptoms of cancer and/or are at an increased risk of developing prostate, pancreatic, GI cancer.
- •Individuals who do not adequately understand verbal explanations or written information in English.
- •Patients • Individuals who are unwilling to take part in the study.
- •Individuals who do not adequately understand verbal explanations or written information in English.
- •Unable to provide written and verbal consent.
- •No direct or indirect lived experience with prostate, pancreatic, GI cancers.
- •Non-clinical key stakeholders/professionals • Individuals who are unwilling to take part in the study • Individuals who are not familiar with cancer biomarkers and medical tests • Individuals with no knowledge of early detection
- •Individuals who do not adequately understand verbal explanations or written information in English
排除标准
- 未提供
结局指标
主要结局
Detection rates of other diseases
时间窗: 1 year
Whether the Man Van model can provide improved men's health services with detection of undiagnosed diabetes, blood pressure as well as lifestyle interventions (smoking, excess alcohol and weight loss advice).
Cancer detection rates
时间窗: 1 year
Whether the Man Van model can improve detection rates of prostate cancer, and reduce morbidity and mortality associated with prostate cancer, providing an economic benefit due to earlier disease detection and management.
次要结局
未报告次要终点
