Back to Search Results- Recruiting
- Diagnostic
- Interventional
- Non Randomized
- Device & Diagnostic Test
- Royal Marsden NHS Foundation Trust
- 18 Years -
Study Purpose
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.
Intervention
Device : MV-POCT Sub-study
Other : Main Man Van Group Sub-study (MV-Eco)
Other : MV-QualQ Sub-study
Diagnostic Test : MV-PRS Sub-study
Other : MV-DNA and MV-UctDNA Sub-study
Other : Man Van patients
Other : MV-SSI Sub-study
Other : MV-TPP Sub-study
Eligibility Requirements
for the Main Study
Man van patient who has attended appointment
MV-TPP
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.
Patients
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:
GPs
• 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
Recruiting status
Recruiting
Estimated enrollment
4000
Study start date
Apr 13, 2022
Study end date
Dec 01, 2026
Last updated
Mar 22, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Device & Diagnostic Test
Study phase
NA
Allocation
Non Randomized
Sponsor:
Royal Marsden NHS Foundation Trust
Collaborator:
RM Partners West London Cancer Alliance
Institute of Cancer Research, United Kingdom
Imperial College London
Investigator:
Nicholas D James, MBBS, FRCP, FRCR, PhD
N/A
Publications
N/A
Websites
N/A
NCT06357416
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