The Man Van Project

NCT06357416 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2024-05-01

No results posted yet for this study

Summary

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

Interventions

DEVICE

MV-POCT Sub-study

Point of care blood testing

OTHER

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

Consent for long-term follow-up of patients

OTHER

MV-QualQ Sub-study

Qualitative questionnaire and interview sub-study

DIAGNOSTIC_TEST

MV-PRS Sub-study

Patients consenting to polygenic risk score testing

OTHER

MV-DNA and MV-UctDNA Sub-study

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

OTHER

Man Van patients

All patients seen in Man Van

OTHER

MV-SSI Sub-study

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

OTHER

MV-TPP Sub-study

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

Sponsors & Collaborators

  • RM Partners West London Cancer Alliance

    collaborator UNKNOWN
  • Institute of Cancer Research, United Kingdom

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicholas D James, MBBS, FRCP, FRCR, PhD · Institute of Cancer Research/Royal Marsden NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2025-10-01
Completion
2026-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357416 on ClinicalTrials.gov