The Man Van Project (NCT06357416)

At a Glance

Age: 18 and older
Sex: Male
Study type: Interventional
Purpose: Diagnostic
Participants needed: 4,000 (estimated)
Sponsor: Royal Marsden NHS Foundation Trust · Other

Who this trial is looking for

About This Trial

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 s…

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.

Trial Locations

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Eligibility Criteria

Patients are eligible to be included in the research study if they are eligible to access the Man Van mobile outreach clinic, which is a novel clinical service delivered by The Royal Marsden Hospital NHS Foundation Trust. The inclusion and exclusion criteria have been designed to be as broad as poss…

Patients are eligible to be included in the research study if they are eligible to access the Man Van mobile outreach clinic, which is a novel clinical service delivered by The Royal Marsden Hospital NHS Foundation Trust. The inclusion and exclusion criteria have been designed to be as broad as possible, in order to include data from as many patients using the Man Van clinical service as possible. As the primary purpose of the Man Van mobile outreach clinic is to screen for prostate, testicular, penile and other cancers that affect men, only men are eligible to be reviewed in the mobile outreach clinic hence only males will be recruited into this study. Inclusion criteria for the Main Study 1. Participating in the linked Man Van mobile outreach clinic 2. Age ≥45 years 3. Male (The initial pilot study had a age criteria of ≥18 years, but this was amended). MV-POCT Inclusion Criteria: 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. MV-QualQ Inclusion Criteria: Any patient attending the Man Van for an assessment. MV-Eco Inclusion Criteria: Any patient attending the Man Van for an assessment. MV-PRS Inclusion Criteria: Any patient attending the Man Van for an assessment and able to provide saliva samples. MV-DNA 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. MV-SSI 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 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

Contacts

Nicholas D James, MBBS, FRCP, FRCR, PhD

02071535130

nick.james@icr.ac.uk

CONTACT

Masood R Moghul, MBBS, FRCS (Urol)

02071535130

masood.moghul@rmh.nhs.uk

CONTACT

The Man Van Project

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