The Man Van Project

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal Marsden NHS Foundation Trust

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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Participating in the linked Man Van mobile outreach clinic

Age ≥45 years

Male

Aged > 18 and over (on date of invitation to participate)

Trial design

Design model

Single group

Treatments tested in this trial

  • MV-POCT Sub-study

    Device

    Point of care blood testing

  • Main Man Van Group Sub-study (MV-Eco)

    Other intervention

    Consent for long-term follow-up of patients

  • MV-QualQ Sub-study

    Other intervention

    Qualitative questionnaire and interview sub-study

  • MV-PRS Sub-study

    Diagnostic test

    Patients consenting to polygenic risk score testing

  • MV-DNA and MV-UctDNA Sub-study

    Other intervention

    Patients consenting to collection of DNA and urine for further study.

  • Man Van patients

    Other intervention

    All patients seen in Man Van

  • MV-SSI Sub-study

    Other intervention

    Semi-structured interviews will be conducted with stakeholders involved in the running of or recruitment to the project.

  • MV-TPP Sub-study

    Other intervention

    Multi-stage qualitative study comprising of interviews and participatory design focus group workshops.

Treatment groups

4,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Main Group (MV-Eco) Sub-studyOther 2 interventions
Group B: Point of care testing (MV-POCT) Sub-studyOther 2 interventions
Group C: Qualitative questionnaire (MV-QualQ) Sub-studyOther 2 interventions
Group D: Polygenic risk scores (MV-PRS) Sub-studyOther 2 interventions
Group E: DNA Collection (MV-DNA) and Urinary Circulating Tumour DNA collection (MV-UctDNA) Sub-studiesOther 2 interventions
Group F: Man Van patientsOther 1 intervention
Group G: Stakeholder service interviews (MV-SSI) Sub-StudyOther 1 intervention
Group H: Target product profile (MV-TPP) Sub-StudyOther 2 interventions

Trial outcomes

Primary outcomes

1

Cancer detection rates

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.

Time frame
1 year
2

Detection rates of other diseases

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).

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Marsden NHS Foundation Trust

Lead sponsor

RM Partners West London Cancer Alliance

Collaborator

Institute of Cancer Research, United Kingdom

Collaborator

Imperial College London

Collaborator