Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
Healthy Volunteers
NCT06357416

The Man Van Project

Led by Royal Marsden NHS Foundation Trust · Updated on 2024-05-01

4000

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

Sponsors

R

Royal Marsden NHS Foundation Trust

Lead Sponsor

R

RM Partners West London Cancer Alliance

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Man Van Project

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male
  • Age 45 years or older
  • Participating in the Man Van mobile outreach clinic
  • Any patient having a PSA and/or HbA1c test as part of Man Van work up or rapid diagnostics clinic
  • Any patient attending the Man Van for assessment
  • Patients able to provide saliva samples for polygenic risk score testing
  • Patients able to provide blood or saliva samples for DNA collection
  • Patients able to provide urine samples for urinary circulating tumour DNA study
  • Stakeholders aged over 18 involved in healthcare or related to Man Van patients (for sub-studies)
  • Healthcare professionals aged over 18, working in UK, experienced with cancer detection and referral
  • Patients aged over 18 with direct or indirect experience with prostate, pancreatic, GI cancers
  • Other key stakeholders aged over 18 knowledgeable of early detection initiatives
Not Eligible

You will not qualify if you...

  • Female
  • Man Van patients who have previously attended an appointment (for certain sub-studies)
  • Individuals unwilling to participate in the study
  • Individuals without experience in adopting new cancer tests and guidelines into practice (GPs)
  • Individuals without experience in detecting, managing, and referring patients with cancer symptoms (GPs)
  • Individuals who do not understand verbal or written English adequately
  • Individuals unable to provide written and verbal consent
  • Patients without any direct or indirect experience with prostate, pancreatic, GI cancers
  • Non-clinical stakeholders unfamiliar with cancer biomarkers and medical tests
  • Individuals not knowledgeable about early detection of cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Royal Marsden Hospital NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

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Research Team

N

Nicholas D James, MBBS, FRCP, FRCR, PhD

CONTACT

M

Masood R Moghul, MBBS, FRCS (Urol)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

8

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