protocolSection identificationModule nctId: NCT06357416, orgStudyIdInfo id: CCR5573, briefTitle: The Man Van Project, acronym: MV, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-13, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Royal Marsden NHS Foundation Trust, class: OTHER, collaborators name: RM Partners West London Cancer Alliance, collaborators name: Institute of Cancer Research, United Kingdom, collaborators name: Imperial College London, descriptionModule briefSummary: 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., conditionsModule conditions: Prostate Cancer, conditions: Urologic Cancer, conditions: Urologic Diseases, conditions: Bladder Cancer, conditions: Diabetes, conditions: Hypertension, conditions: Mental Health Issue, conditions: Alcoholism, conditions: Smoking, conditions: Renal Cancer, conditions: Testis Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: MV-POCT Sub-study, interventions name: Main Man Van Group Sub-study, interventions name: MV-QualQ Sub-study, interventions name: MV-PRS Sub-study, interventions name: MV-DNA and MV-UctDNA Sub-study, interventions name: Man Van patients, outcomesModule primaryOutcomes measure: Cancer detection rates, primaryOutcomes measure: Detection rates of other diseases, eligibilityModule sex: MALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Marsden Hospital NHS Foundation Trust, status: RECRUITING, city: London, zip: SW3 6JJ, country: United Kingdom, contacts name: Ann Gandolfi, role: CONTACT, phone: 02086613903, email: ann.gandolfi@rmh.nhs.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False