The Man Van Project
MV
1 other identifier
interventional
4,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Apr 2022
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMay 1, 2024
April 1, 2024
3.5 years
March 22, 2024
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
1 year
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).
1 year
Study Arms (8)
Main Group (MV-Eco) Sub-study
OTHERPatients seen in the Man Van, including those consenting to long-term follow-up of data.
Point of care testing (MV-POCT) Sub-study
OTHERPatients consenting to a point of care blood test for either a PSA and/or HbA1c
Qualitative questionnaire (MV-QualQ) Sub-study
OTHERPatients consenting to participate in a qualitative study about their experience of the Man Van.
Polygenic risk scores (MV-PRS) Sub-study
OTHERPatients consenting for a polygenic risk score test.
DNA Collection (MV-DNA) and Urinary Circulating Tumour DNA collection (MV-UctDNA) Sub-studies
OTHERPatients consenting to collection of DNA and/or urine for as yet undetermined future ethically-approved research.
Man Van patients
OTHERAll patients seen within Man Van
Stakeholder service interviews (MV-SSI) Sub-Study
OTHERSemi-structured interviews with people involved in the running of the project or those who may help in recruiting patients. This may include but not be limited to: GPs, community leaders (e.g. church pastors), charity leaders, staff involved in delivery (nurses, co-ordinators), men who did not attend the service and relatives of men.
Target product profile (MV-TPP) Sub-Study
OTHERWe will develop an equity-focused Target Product Profile (TPP) that can provide a summary of the requirements for an optimal yet realistic profile of biomarker tests designed to work in mobile testing clinics, such as the Man Van.
Interventions
Consent for long-term follow-up of patients
Qualitative questionnaire and interview sub-study
Patients consenting to polygenic risk score testing
Patients consenting to collection of DNA and urine for further study.
All patients seen in Man Van
Semi-structured interviews will be conducted with stakeholders involved in the running of or recruitment to the project.
Multi-stage qualitative study comprising of interviews and participatory design focus group workshops.
Eligibility Criteria
You may not qualify if:
- 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.
- Participating in the linked Man Van mobile outreach clinic
- Age ≥45 years
- Male
- (The initial pilot study had a age criteria of ≥18 years, but this was amended).
- MV-POCT
- MV-QualQ
- MV-Eco
- MV-PRS
- MV-DNA
- MV MV-UctDNA
- MV-SSI
- 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
- Man van patient who has attended appointment
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Marsden NHS Foundation Trustlead
- RM Partners West London Cancer Alliancecollaborator
- Institute of Cancer Research, United Kingdomcollaborator
- Imperial College Londoncollaborator
Study Sites (1)
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas D James, MBBS, FRCP, FRCR, PhD
Institute of Cancer Research/Royal Marsden NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
April 10, 2024
Study Start
April 13, 2022
Primary Completion
October 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
May 1, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share