Trial Title:
The Man Van Project
NCT ID:
NCT06357416
Condition:
Prostate Cancer
Urologic Cancer
Urologic Diseases
Bladder Cancer
Diabetes
Hypertension
Mental Health Issue
Alcoholism
Smoking
Renal Cancer
Testis Cancer
Conditions: Official terms:
Prostatic Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Testicular Neoplasms
Urologic Diseases
Alcoholism
Conditions: Keywords:
mobile health
targeted screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MV-POCT Sub-study
Description:
Point of care blood testing
Arm group label:
Point of care testing (MV-POCT) Sub-study
Intervention type:
Other
Intervention name:
Main Man Van Group Sub-study (MV-Eco)
Description:
Consent for long-term follow-up of patients
Arm group label:
Main Group (MV-Eco) Sub-study
Intervention type:
Other
Intervention name:
MV-QualQ Sub-study
Description:
Qualitative questionnaire and interview sub-study
Arm group label:
Qualitative questionnaire (MV-QualQ) Sub-study
Intervention type:
Diagnostic Test
Intervention name:
MV-PRS Sub-study
Description:
Patients consenting to polygenic risk score testing
Arm group label:
Polygenic risk scores (MV-PRS) Sub-study
Intervention type:
Other
Intervention name:
MV-DNA and MV-UctDNA Sub-study
Description:
Patients consenting to collection of DNA and urine for further study.
Arm group label:
DNA Collection (MV-DNA) and Urinary Circulating Tumour DNA collection (MV-UctDNA) Sub-studies
Intervention type:
Other
Intervention name:
Man Van patients
Description:
All patients seen in Man Van
Arm group label:
DNA Collection (MV-DNA) and Urinary Circulating Tumour DNA collection (MV-UctDNA) Sub-studies
Arm group label:
Main Group (MV-Eco) Sub-study
Arm group label:
Man Van patients
Arm group label:
Point of care testing (MV-POCT) Sub-study
Arm group label:
Polygenic risk scores (MV-PRS) Sub-study
Arm group label:
Qualitative questionnaire (MV-QualQ) Sub-study
Arm group label:
Target product profile (MV-TPP) Sub-Study
Intervention type:
Other
Intervention name:
MV-SSI Sub-study
Description:
Semi-structured interviews will be conducted with stakeholders involved in the running of
or recruitment to the project.
Arm group label:
Stakeholder service interviews (MV-SSI) Sub-Study
Intervention type:
Other
Intervention name:
MV-TPP Sub-study
Description:
Multi-stage qualitative study comprising of interviews and participatory design focus
group workshops.
Arm group label:
Target product profile (MV-TPP) Sub-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.
Detailed description:
Background
Early intervention is potentially lifesaving for a range of conditions. A key cause of
death from cancer and other causes is late presentation and there are key barriers to
early access such as low education levels, difficult access to primary care (for example
due to anti-social working hours) as well as lack of knowledge of relevant symptoms that
might trigger referral and investigation. The Man Van project seeks to address some of
these reasons for late presentation and started with an initial focus on prostate cancer.
The project has now broadened to include a range of conditions that are major causes of
mortality and morbidity in men such as heart and liver disease, other urological cancers
(penile, testicular, bladder, kidney). The Man Van clinics will be focused on populations
at risk of delayed presentation to healthcare systems such as men in manual or low skill
jobs and workplaces with high numbers of black and ethnic minority employees.
Prostate cancer is the most common cancer in men in the United Kingdom (UK), with over
50,000 new cases diagnosed and 15,000 lives lost to prostate cancer in the UK each year
1. This is of particular concern for black African and African Caribbean men who carry a
1 in 4 risk of developing prostate cancer, and for men with a family history of the
disease. Another challenge is that, typically, men tend to approach their GP for men's
health issues when symptoms are severe. Around 20-25% of men with prostate cancer still
present to A&E with retention. At this late-stage treatment is less likely to be
successful and certainly will carry more morbidity for the patient and cost for the
health care system. The recent COVID-19 pandemic has further exacerbated this issue with
routine referrals to cancer diagnostics clinics dropping by around a third (in house
data, Royal Marsden Hospital), suggesting a growing reservoir of un-diagnosed cancer in
the community.
Till date there is no consensus on the modality of prostate cancer screening, but most
studies have focussed on PSA as a screening tool, with MRI scanning and biopsies as
adjuncts to this. PSA itself has a controversial history in screening for prostate cancer
with studies showing differing results. A key issue in using PSA as a screening tool
comes from the definition of what a 'normal' PSA is. PSA increases with age and with
benign growth of the prostate but can also be elevated in urinary tract infections or
prostatic inflammation. Oesterling's age specific PSA ranges from 1993 are still in use
today. Prostate cancer is of course another cause of PSA elevation. Having a higher PSA
threshold for investigation increases the positive predictive value for detecting
prostate cancer but lowers the negative predictive value, and the reverse is true as
well. A study by Gerstenbluth documented a positive predictive value of 98.5% for PSA in
detecting prostate cancer with a PSA of 50ng/ml or above.
The evidence for screening is also controversial resulting in differing guidance around
the world. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial from
the USA looked at systematic vs opportunistic screening in over 76000 men. Using a PSA
threshold of over 4 and 7-10 years of follow-up no significant difference in mortality
from prostate cancer was found between the screened and non-screened arms. However, the
study had high rates of contamination between the two groups with an estimated 74% of the
control group subject to at least one routine PSA test during the trial (95% in the
intervention arm) and around 50% of men in the control group tested each year.
The European Randomized Study of Screening for Prostate Cancer (ERSPC) has been studying
186,000 men aged 55 to 69 in Europe since 1992. Now in its 16th year of follow-up6
results show a 20% reduction in cancer specific survival, and the numbers needed to treat
was now below that which is observed in breast cancer strengthening the argument for some
form of screening. A total of seven studies in different regions of Europe were included,
with each study utilising different screening criteria and treatment protocols, interval
timing, and PSA cut-offs (between 3 and 4), again muddying the waters. As a result of
this conflicting evidence the National Institute of Clinical Excellence (NICE) guidelines
suggest a risk stratified approach along with patient counselling. The guidelines
recommend giving a PSA test to any man over the age of 50 years who requests it as well
as offering it to men with lower urinary tract symptoms, haematuria, erectile dysfunction
or symptoms that may suggest advanced prostate cancer such as unexplained bone pain or
weight loss. However, routine systematic screening is not recommended.
Rationale
The rationale behind the introduction of the Man Van mobile outreach service is to
increase patient access and support to cancer investigation pathways. This is
particularly important in patient groups from lower socio-economic and high risk groups
where delay in early intervention can result in delayed presentation and adverse health
outcomes. We hope to demonstrate the feasibility and applicability of such a service to
improve patient outcomes and hope to gather important qualitative and DNA based data for
further research.
This research project will analyse the clinical data obtained from each patient's routine
health screening and long-term follow-up data from NHS Digital and other healthcare
providers, to make a full assessment of how effective the Man Van mobile outreach model
is in diagnosing prostate and other male cancers by making a comparison with the current
detection rates from diagnoses made under the traditional screening and diagnosis
pathway. It is anticipated that the results of this study will provide further evidence
for the commissioning of targeted outreach programmes for early detection of prostate and
other male cancers.
Point of care testing (MV-POCT)
Point of care blood testing is a feature of the van that will allow instant results to be
given to patients, preventing the need for follow-up appointments and speeding up
diagnoses. Both PSA and HbA1c tests are currently carried out on the van using formal
laboratory blood tests which are then sent via courier to the Royal Marsden biochemical
laboratory.
As well as a formal laboratory validation process which is required before any point of
care machine can be used (which is not part of the research protocol) we will determine
what effect the difference between laboratory and point of care testing may have on the
decision making process for patients.
The clinical decision making from PSA testing will be whether an onwards referral for
prostate cancer investigation is recommended by the clinical team. For HbA1c it will be
whether a primary care referral for diabetic management is recommended by the clinical
team. The laboratory value will be taken as the 'true' value in this instance as all
final clinical decision making based on this.
Qualitative questionnaire (MV-QualQ)
As the Man Van provides a new clinical model for assessing patients, the patients'
perspective on the model, and comparisons to existing clinical services is important.
Going into more detail than a service evaluation questionnaire, a qualitative study has
been developed to better understand how patients feel about and react to the service. A
qualitative questionnaire has been developed following discussion group input via a
modified Delphi process.
The Delphi method is a commonly used method for achieving a consensus of opinion of real
world knowledge from experts in the field. It was developed by Dalkey and Helmer at the
Rand Corporation in the 1950s and is aimed at problem-solving, idea-generation, or
determining priorities.
The complexity of issues that prevent men from seeking or finding healthcare and our lack
of understanding is the key driver for this study. This is particularly relevant for men
from ethnic minorities and lower socio-economic groups. Understanding the barriers and
facilitators to healthcare access may provide further support of the Man Van project and
may help develop further research themes aimed at increasing healthcare access.
In-depth qualitative patient interviews will be carried out on at least 5 patients to
further delineate themes which arise from the questionnaires. With permission interviews
will be recorded and transcribed to aid thematic analysis.
Health Economic Analysis (MV-Eco)
A key element of the Man Van project is its long-term use as a novel method of targeted
screening and improving health care outcomes. Like all NHS funded services a cost-benefit
analysis is integral to supporting the case for this project into the future. Health
economic arguments form key parts of discussion for NICE and NHS England commissioning
groups.
The health economic arguments for prostate cancer screening remain unclear as they do for
various diseases, however a combined approach that targets high risk patients and assess
for prostate cancer, bladder/renal cancer, diabetes, hypertension and other diseases
assessed for in the Man Van may make for a stronger economic argument.
Polygenic risk scores (MV-PRS)
Prostate cancer is the commonest cancer in men in the Western world, with over 40,000 new
cases per annum. However, its aetiology remains very poorly understood. The substantial
variation in incidence rates worldwide suggests that lifestyle risk factors are important
however, no definite lifestyle risk factors have been identified till date.
Family history has been identified as a significant risk factor for prostate cancer, as
it is in many other cancers and diseases. Although this is likely due to inherited
genetic pre-disposition, causation is yet to be fully established.
Although gene mutations have been discovered as being causative factors for many diseases
PRS allow for the amalgamation of greater variants in order to explain a larger
proportion of diseases rather than single low penetrance variants. PRS has the potential
to enhance risk susceptibility to a greater proportion of the population and offer new
avenues in patient screening and disease prevention.
The clinical application of PRS is subject of intense debate and ongoing research. We
hope to add to this area of ongoing study, in particular with the combination of offering
lifestyle modification advice in the context of PRS. PRS scores will be generated from
saliva samples of DNA. As is common with many studies the under recruitment and under
representation of ethnic minority patients remains an issue, resulting in less
representative polygenic risk scores for patients of non-white ethnicities. We hope to
address this via the Man Van by recruiting higher proportions of other ethnicities.
DNA Collection (MV-DNA)
Genetic studies have become a key part of cancer research, both for early diagnosis and
prognostic reasons. A key issue for studies is trial recruitment, with significant issues
in the recruitment of ethnic minorities to trials, which is particularly relevant when a
disease may affect a particular ethnicity more (for example prostate cancer in Black
men). DNA collection with either blood or saliva samples can help to build a database
which can be used for further genetic studies.
Urinary Circulating Tumour DNA collection (MV-UctDNA)
Despite much research into the development of novel urinary biomarkers for bladder
cancer, the mainstay of diagnosis remains invasive with a flexible (or rigid) cystoscopy.
Even cystoscopy is only carried out after a red flag symptom triggers a referral
(haematuria or recurrent infections). Several tests exist but none has replaced
cystoscopy as the gold standard either for diagnosis of new bladder cancer or disease
recurrence. Circulating tumour DNA (ctDNA) from urine has potential as a new avenue of
development of diagnostic tests for bladder cancer and also prostate cancer.
Criteria for eligibility:
Criteria:
Patients are eligible to be included in the research study if they are eligible to access
the Man Van mobile outreach clinic, which is a novel clinical service delivered by The
Royal Marsden Hospital NHS Foundation Trust. The inclusion and exclusion criteria have
been designed to be as broad as possible, in order to include data from as many patients
using the Man Van clinical service as possible.
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.
Inclusion criteria for the Main Study
1. Participating in the linked Man Van mobile outreach clinic
2. Age ≥45 years
3. Male
(The initial pilot study had a age criteria of ≥18 years, but this was amended).
MV-POCT
Inclusion Criteria: Any patient having a PSA and/or an HbA1c test as part of a Man
Van work up, or via the our rapid diagnostics clinic.
MV-QualQ
Inclusion Criteria: Any patient attending the Man Van for an assessment.
MV-Eco
Inclusion Criteria: Any patient attending the Man Van for an assessment.
MV-PRS
Inclusion Criteria: Any patient attending the Man Van for an assessment and able to
provide saliva samples.
MV-DNA
Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to
provide blood/saliva samples.
MV MV-UctDNA
Inclusion Criteria: Any patient attending the Man Van for an assessment, and able to
provide urine samples.
MV-SSI
Inclusion criteria:
- 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
Exclusion criteria:
- Man van patient who has attended appointment
MV-TPP
Inclusion criteria:
Healthcare Professionals
- Aged > 18 and over (on date of invitation to participate)
- Speaks English
- Works within the UK
- Profession: GPs, Practice Staff (Nurses, Physician Assistants and Associates
- Healthcare assistants)
- Experienced in adopting new tests and guidelines into practice.
- Experienced in detecting, managing, and referring symptoms and asymptomatic
patients with symptoms of prostate, pancreatic, GI cancer and/or are at an
increased risk of developing these cancers.
Patients
- Aged > 18 and over (on date of invitation to participate)
- Speaks English
- Lives in the UK
- Patients with direct and in-direct experience with prostate, pancreatic, GI
cancers.
- Patients at an increased risk of developing prostate, pancreatic, GI cancer in
accordance with known risk factors, which includes age, smoking, being
overweight or obese, family history and genetic factors, pancreatitis, and
diabetes.
Other key stakeholders/professionals
• Aged > 18 and over (on date of invitation to participate)
• Speak English
- Works within the UK
- Professions: medical devices and biomedical researchers, scientists,
representatives for major regulatory and funding bodies
- Knowledgeable of Early Detection initiatives (tests, outreach programes)
Exclusion criteria:
GPs
• Individuals who are unwilling to take part in the study.
- Individuals with no experience in adopting new cancer tests and guidelines into
practice.
- Individuals with no experience in in detecting, managing, and referring
patients with symptoms of cancer and/or are at an increased risk of developing
prostate, pancreatic, GI cancer.
- Individuals who do not adequately understand verbal explanations or written
information in English.
Patients • Individuals who are unwilling to take part in the study.
• Individuals who do not adequately understand verbal explanations or written
information in English.
• Unable to provide written and verbal consent.
• No direct or indirect lived experience with prostate, pancreatic, GI cancers.
Non-clinical key stakeholders/professionals • Individuals who are unwilling to take
part in the study • Individuals who are not familiar with cancer biomarkers and
medical tests • Individuals with no knowledge of early detection
• Individuals who do not adequately understand verbal explanations or written
information in English
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Royal Marsden Hospital NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ann Gandolfi
Phone:
02086613903
Email:
ann.gandolfi@rmh.nhs.uk
Start date:
April 13, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
RM Partners West London Cancer Alliance
Agency class:
Other
Collaborator:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
Imperial College London
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06357416
