HHTU News Roundup

CONIFAS 2 sites get the greenlight

Two new sites in the CONIFAS 2 study were given the green light in August. These were Leeds Community Healthcare NHS Trust and Cornwall Partnership NHS Foundation Trust. The team are pleased that the intervention can now reach more children with ADHD. 

The intervention is a home-based, family-led intervention delivered with professional third-party telephone support. It encourages daily engagement with nature for at least 10 minutes and includes activity cards and supportive psychoeducational elements. 

The study is funded by the NIHR Research for Patient Benefit (RfPB) programme and sponsored by Humber Teaching NHS Foundation Trust. It is led by Dr Hannah Armitt, Clinical Research Psychologist at Humber Teaching NHS Foundation Trust, and managed at HHTU by Trial Manager Kathryn Date. 

Studies get approvals

The NEOREHAB and CANBenefit 3 studies have now received approval, and the teams are working towards study green lights so they can begin recruiting. 

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NEOREHAB is an HHTU-managed study funded by Yorkshire Cancer Research and sponsored by the University of Hull. It is led by Dr Cecilia Pompili, Thoracic Surgeon and Senior Clinical Lecturer in Psychosocial Oncology, and managed at HHTU by Trial Manager Grant Constable. 

Patients with curable surgical lung cancer are often elderly, current smokers, and have medical comorbidities. Since March 2023, a new treatment involving chemo-immunotherapy before surgery has been offered and has been reported to improve survival. However, 20% of patients are unable to undergo surgery, while others experience treatment-related side effects. 

To maximise the benefits of the neoadjuvant regimen, there is an urgent need to optimise patients’ health before, during and after surgery. This will help ensure the advantages of immunotherapy translate into improved survival outcomes. Investigating guideline-recommended cardiopulmonary fitness in this context is important, as it can identify predictors of fitness decline and surgical complications, helping to identify high-risk groups who may benefit most from an exercise programme. 

The NEOREHAB study will evaluate the feasibility of providing a hybrid exercise programme for patients undergoing neoadjuvant treatment for resectable lung cancer. 

The study will assess the impact of this intervention on quality of life, fitness for surgery, postoperative morbidity and serum inflammatory markers. 

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The CANBenefit 3 study is also funded by Yorkshire Cancer Research. It is led by Dr Cindy Forbes, Senior Lecturer in Physical Activity at Hull York Medical School. 

CANBenefit 2, like similar research, highlighted the challenges of recruitment into a clinical trial of this nature. Patient pathways made it difficult to determine the most appropriate time to approach patients for research consent, and many declined to participate because they felt overwhelmed. 

In this study, a new cancer rehabilitation service will be embedded within standard NHS cancer services to deliver a tailored activity, nutrition and wellbeing programme adapted from the CANBenefit 2 programme (IRAS: 306062). 

The Cancer Rehabilitation Service will use a stepped approach to provide personalised activity, nutrition and wellbeing advice to people with lung cancer. Delivered through accessible resources guided by an Exercise Physiologist (EP) and integrated into standard care pathways, all referred patients who engage with the service will receive an initial EP assessment and a tailored Cancer Rehabilitation Service programme. Those requiring additional support will be stepped up to receive further intervention based on weekly assessments (see Section 2.2 for further detail). 

This study will evaluate the feasibility and acceptability of delivering the programme as part of standard cancer rehabilitation care in Yorkshire cancer clinics, helping to inform future large-scale implementation and evaluation.

Other Summer project headlines:

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HHTU News Roundup

ProACTIVE WP 2a Updates

We are delighted to share that Work Package 2a (WP2a) of the ProACTIVE study has successfully closed to recruitment, having achieved its target recruitment numbers. 

The ProACTIVE (Programme of Research for Alcohol Care Teams: Impact, Value and Effectiveness) study is funded by the National Institute for Health and Care Research (NIHR) and is led by Dr Tom Phillips (Centre for Addiction and Mental Health Research) and Professor Julia Sinclair (University of Southampton). 

At the Hull Health Trials Unit, this important milestone has been made possible through the dedication and hard work of Mahboobeh, Beccy and Judith, who have worked tirelessly to keep the study on track and ensure recruitment targets were met. 

Evaluating the Impact of Alcohol Care Teams 

The aim of ProACTIVE WP2a is to evaluate the effectiveness of Alcohol Care Teams (ACTs). ACTs are specialist hospital-based services that provide care and support for people experiencing alcohol-related problems. The study compares outcomes for patients attending hospitals with an ACT to those attending hospitals without one, helping to strengthen the evidence base for these important services and inform future healthcare delivery. 

A total of 546 participants were recruited to the study: 

• 302 participants from hospitals without an ACT 

• 244 participants from hospitals with an ACT 

Although recruitment has now closed, the study remains active while the research team completes six-month follow-up data collection with participants. 

Thank You to Everyone Involved 

Reaching this milestone would not have been possible without the support and commitment of a large number of individuals and organisations. We would like to extend our sincere thanks to all 546 participants who took part in the study, as well as the many Research Assistants and staff across all participating sites who contributed to this important research. 

The participating hospital sites are: 

• Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust 
• St Helier Hospital
• Chelsea and Westminster Hospital NHS Foundation Trust 
• Scarborough General Hospital 
• Poole Hospital 
• The Rotherham Hospital NHS Foundation Trust 
• St Thomas’ Hospital 
• Hull Royal Infirmary

Study Protocol Published 

Alongside this recruitment success, the ProACTIVE research team has recently made available the study protocol for WP2a, providing further information on the methodology being used to assess the effectiveness of Alcohol Care Teams in England. 

Thomas Phillips, Simon Coulton, Colin Angus et al. Prospective pragmatic quasi-experimental study to assess the impact and effectiveness of alcohol care teams (ACTs) targeting adults with alcohol dependence admitted to NHS hospitals in England: the ProACTIVE prospective patient study protocol was published as a preprint on Research Square on 12 June 2026. 

You can read the above paper here https://www.researchsquare.com/article/rs-9896476/v1

As the study moves into its follow-up phase, we look forward to sharing the findings and insights from this important programme of research, which aims to improve care and outcomes for people affected by alcohol dependence. 

Data Security Protection Toolkit Submitted

We’re delighted that the Data Security and Protection Toolkit (DSPT) has been submitted for 2025–26. The DSPT is the NHS’s annual self-assessment that demonstrates how organisations handle, protect and securely manage sensitive data. In health research, maintaining high standards of data security is essential to safeguarding participant information, meeting legal and regulatory requirements, and preserving public trust. This submission reflects the commitment of colleagues across the organisation to ensure that data is protected and used responsibly to support high-quality research. 

Other June headlines:

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HHTU News Roundup

DOORstep wins poster award

Dr Charlotte Kelly and Dr Mahe Haji Sadeghi attended the first Women’s Health Conference and won the publicly voted first prize was awarded to the poster for the DOORstep study, a Hull Health Trials Unit managed study funded by Yorkshire Cancer Research. DOORstep is a study looking at whether offering free transport to breast screening appointments increases attendance rates. Huge congratulations to the entire DOORstep team, including Charlotte and Mahe who are pictured here with the winning poster.

The Women’s Health Conference 2026 took place at the University of Hull and brought together leaders in research, healthcare, policy, and community support, all dedicated to improving the health and wellbeing of women and girls. It was extremely well received by everyone from the HHTU who attended.

Congratulations once again to the DOORstep team on this fantastic achievement.

MOI-A team attends conference

The MOI-A study team was delighted to attend IDR26, the International Drug Repurposing Conference in Brussels, represented by Amy Wilkinson (Trial Manager), Judith Cohen (HHTU Director), Professor Nick Bishop (Chief Investigator), and Charlotte Heath (Sponsor Representative).

Over two inspiring days, delegates from across the globe—including researchers, clinicians, patients, and parents—came together to explore the current landscape and future potential of drug repurposing, particularly for rare diseases. The conference showcased exciting developments in the field, including the growing role of artificial intelligence in identifying new therapeutic opportunities and highlighting ongoing studies driving innovation. As the MOI-A study investigates the repurposing of losartan as a potential treatment for osteogenesis imperfecta (OI), a rare genetic condition, it was especially valuable to engage with the wider drug repurposing community.

MOI-A is proud to be one of the demonstration projects within the REMEDi4All consortium, which organised this excellent event. The conference highlighted the significant progress being made across the field and reinforced the importance of collaboration in accelerating access to new treatment options for people living with rare diseases.

RE-SCAIT is open!

RE-SCAIT is a 6 stage study that has recently opened with the first work package (WP). WP 1b involves co-design workshops with healthcare professionals from participating NHS Trusts. The aim is to develop an effective implementation strategy to increase the chances of successful implementation of a waking salivary cortisone (WSC) test for the diagnosis of adrenal insufficiency into routine clinical practice. Recently the first 2 sites in WP1b have been greenlighted and the workshops are being arranged.

These are the first steps in this interesting study and we look forward to seeing how the study progresses over time.

Other May project headlines:

You can find more about each project here.

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HHTU News Roundup

Yorkshire Cancer Research walk

Researchers, people affected by cancer and charity supporters are taking part in a Yorkshire-wide baton relay as part of this year’s We Walk for Yorkshire challenge. Throughout May, the Baton for Yorkshire will pass through 35 locations across the region, symbolising the 35,000 people diagnosed with cancer in Yorkshire each year.

We have 4 current clinical trials funded by YCR and another 4 data analysis studies in the Data Safe Haven. NeoRehab is one of the clinical trials and is exploring how improving fitness in people with lung cancer can influence their surgical outcomes.

It was an honour for Team NeoRehab to help kick off the baton relay, with Chief Investigator Dr Cecilia Pompili receiving the baton from the Active Together team at the start of this month‑long journey. Dr Pompili and NeoRehab Trial Manager Grant Constable then completed the next leg of the relay, handing the baton on to Yorkshire Cancer Research supporters Smailes Goldie.

IMPACT-W Update

IMPACT W is led by Laura Hermann a HHTU based PhD staff member and the study is aiming to improve the recruitment of women to clinical trials. The study continues to recruit well, with two additional staff focus groups completed, bringing the total to nine staff participants and 14 participants from the general public recruited to date. There are now five sites actively identifying participants for the study across primary, secondary, mental health and community healthcare settings. These participants are clinical staff members and also people that have declined to take part in research. We are really interested to see what the results of Laura’s investigations are.

Results paper published

A results paper from the Lincolnshire POACHER study, for which our Director Judith Cohen was a co-applicant, has now been published. HHTU also supported the study by providing the electronic data capture platform through REDCap Cloud.

The randomized controlled trial investigated whether organic disease may be masquerading as irritable bowel syndrome (IBS). IBS is a chronic relapsing disorder for which there are currently limited diagnostic investigations when patients present with IBS-like symptoms. However, around 50% of patients do not improve following the standard diagnostic approach, suggesting that alternative underlying conditions may be missed.

Participants in the study were randomized to receive either standard care based on National Institute for Health and Care Excellence guidelines or an intervention. The intervention involved research nurse-led structured investigations designed to identify organic pathology including treatment protocols targeting abnormal investigation results.

The study found that among 74% of intervention participants who completed the intervention, appropriate treatment of alternative diagnoses led to sustained clinical improvement.

BREEZE-2 recruitment competition

And finally we couldn’t not share the very cute spring version of BREEZE-2 recruitment competition. Well done to the Wolverhampton site for securing first place. We are already looking forward to seeing what the summer recruitment competiotion will look like.

Other April project headlines:

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HHTU News Roundup

ProACTIVE update

The proactive study is a 4 stage work package evaluating Alcohol Care Teams (ACTs). It is funded by NIHR Health and Social Care Delivery (HSDR) and sponsored by the University of Southampton. Prof Tom Phillips at the University of Hull and Prof Julia Sinclair at the University of Southampton are the chief investigators. ACTs are specialist services within hospitals that provide care for people with alcohol-related problems. Not all hospitals in England have an alcohol care team and there is limited evidence about the effectiveness of ACTs for the people who receive care from them.

ProACTIVE Work Package 2a (WP2a) is assessing the effectiveness of alcohol care teams by comparing the outcomes of people with alcohol-related problems who attended hospitals with alcohol care teams, Optimised Alcohol Care Teams (OACT) to those who attended hospitals with none, Non Optimised Alcohol Care Teams (NoACT).

Total recruitment in WP2a to date is 472 participants. OACT sites have completed recruitment with 244 participants and they are now closed to recruitment. NoACT sites are still open to recruitment and have recruited 228 participants to date. This includes 8 participants recruited in March.

The study is following up patients for six months to evaluate the impact of ACTs on patient and service outcomes. A total of 433 six-month follow-ups have been completed, representing a completion rate of over 70%. 16 follow-ups were completed in March.

DAMPen-D 2 study update

Around one third of people have delirium on admission to a Palliative Care Units (PCUs) and another third develop it during their stay; delirium causes distress, functional decline, higher care needs and unplanned hospital admissions. National guidance exists but it is hard for PCUs to implement because delirium care is complex and involves many people (Staff, family, carers). 

We are aiming to improve the Detection, Assessment, Management and Prevention of Delirium through our intervention training with PCU staff. We have developed this intervention and are now looking to roll this our across PCUs in the UK.

We are working with 20 Palliative Care Units across England, Scotland and Wales where 10 will have this Intervention and 10 will continue with usual care. 

The study is funded by the National Institute for Health Research. The study design has an initial pilot phase to identify any issues that would point to the study design not working. We are delighted to have passed this pilot phase and are now underway with the main study. 

As of April 2026, we have 15 sites up and running with two further sites very close to being greenlighted. Recruitment is going to finish at the end of year but there has been an excellent start.

New Data Manager

We are delighted to welcome a new member to the team. Deepika Reddy joins us as a Data Manager. Deepika joins us with a background working in large Contract Research Organisations (CROs), bringing valuable experience in professional services support within complex research environments.  She will be working across the portfolio to support the delivery of high-quality clinical trials and research studies. We’re excited to have Deepika on board and look forward to working together.

HHTU are taking part in FACTS

We are underway with Flourishing As Clinical Trial Staff (FACTS) where we are adopting a number of working practices to promote wellbeing within the Trials unit. FACTs is a Nottingham Clinical Trials Unit managed study which aims to target the unique challenges brought by working within clinical trials within the UK. The study is looking at how their guidance (developed from survey data collected 484 participants from UK Clinical Trials Units and focus groups) is implemented in our Clinical Trials Unit. This includes social activities and challenges for our staff. Look out for further updates on this throughout the year.

Other March project headlines:

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HHTU News Roundup

Protocol paper published

The protocol for the STARLIT-3 Study has been published in BMJ Open.

STARLIT-3 is led by Dr Charlotte Elder at the University of Sheffield and managed by Kathryn Date here at the HHTU. It is the third study of the STARLIT programme of work.

The study is evaluating a novel, needle-free approach to diagnosing adrenal insufficiency — using Nasacthin nasal spray and salivary cortisol measurement instead of the injections and blood samples required for the Short Synacthen Test.

This randomised 2-way crossover trial will recruit 32 patients with adrenal insufficiency across Sheffield Children’s Hospital and Royal Hallamshire Hospital. Participants will receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected at baseline, and at 30 and 60 minutes after drug administration.

The study will then compare glucocorticoid levels to determine whether the Nasacthin test can accurately diagnose adrenal insufficiency, alongside assessing safety, tolerability, usability and patient acceptability.

This work could represent an important step forward in making adrenal insufficiency testing less invasive and more accessible.

The study is funded by the Medical Research Council and sponsored by Sheffield Children’s NHS Foundation Trust.

You can read the full protocol here: https://bmjopen.bmj.com/content/16/2/e112708.full

Researcher recruitment

It’s a busy time for recruiting researchers around here at the moment. 1 post working on DESTIGMATISE has just closed but there are still 3 researcher jobs currently live on the University of Hull Jobs page. These are working for clinical trials that are being delivered in collaboration with the HHTU.

You can read about the 3 roles below and the studies they will be working on below. This will also give you a sneak peak into 4 of our studies currently in set up!!

Postdoctoral Researcher in Implementation Science (Closing date 12 March)

The successful applicant will play a major role in delivering the NEWDAY-ABC process evaluation (60%) and Re-SCAIT work packages (40%), contributing as appropriate in each study to obtaining research governance and ethical approvals, conducting and analysing qualitative semi-structured interviews with study participants, health professionals & managers, non-participant observation and analysis of intervention delivery, and experience-based co-design workshops for implementation strategy development and tailoring/optimisation. Achieving the duties of the post will require active collaboration with the studies’ public involvement members and study leads/partners at the University of Hull, University of Sheffield, and study sites.

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Postdoctoral-Researcher-in-Implementation-Science_JR101994

Qualitative Research Fellow (STEPFORWARD) (Closing date 19 March)

The post holder will undertake the qualitative work within the STEPFORWARD trial. The trial starts with an internal pilot study within which an embedded qualitative process evaluation will run to understand the acceptability of the intervention and trial processes. During the pilot study the postholder will interview trial consenters and decliners to capture their experience of the trial, and with staff to identify barriers and facilitators to recruitment. The postholder will use the data to inform and amend the recruitment strategy as required. The postholder will also conduct interviews with participants after the prosthesis is fitted to understand engagement and prosthesis use.

During the main part of the trial, as part of the SWAT, the postholder will complete semi-structured interviews with site staff and participants to explore the acceptability of using AI technology during recruitment. Towards the end of the trial the postholder will use surveys and interviews with staff to develop an implementation plan using Normalisation Process Theory (NPT).

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Qualitative-Research-Fellow–STEPFORWARD-_JR102077

Qualitative Research Fellow (Neorehab) (Closing date 19 March)

The post holder will undertake the qualitative work within the NEOREHAB trial. This will include focus groups with stakeholders (clinicians, exercise physiologists, patients) to refine the intervention; semi-structured interviews with patients and clinicians in the early months of the trial to pro-actively identify any issues with study processes; further interviews with patients and clinicians to gain an in-depth understanding of trial feasibility and acceptability.

At the end of the study the post holder will also interview patients and clinicians from different specialities to explore ways care could be redesigned, which clinicians should monitor patients, and how best to support patients.

https://uoh.wd103.myworkdayjobs.com/en-GB/University_of_Hull_Careers/details/Qualitative-Research-Fellow–Neorehab-_JR102074

Other February headlines:

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HHTU News Roundup

CONIFAS2 is live

We’re delighted to share that Co-produced nature-based intervention feasibility for children with ADHD Study (CONIFAS2) is now open to recruitment! This study is led by Dr Hannah Armitt with Kathryn Date managing the trial at HHTU.

CONIFAS2 is intervention is a home-based, family-led intervention delivered with professional third-party telephone support. It encourages daily engagement with nature for at least 10 minutes, including activity cards and supportive psychoeducational elements. CONIFAS2 is ready to be tested in NHS funded neurodiversity services assessing the feasibility and acceptability of a full-scale effectiveness trial.

Protocol Paper Published

DOORStep have a newly published protocol paper in BMJ Open. This study assesses whether offering free, bookable, door-to-door transport to and from breast cancer screening appointments could increase screening attendance. This cluster-randomised GP feasibility trial is funded by Yorkshire Cancer Research, led by Chief Investigator Charlotte Kelly, and managed by Mahboobeh Haji Sadeghi at the Hull Health Trials Unit. The photo below is DOORStep team member outside a breast screening van where attendees were encouraged to complete a travel survey. This stage of the study is complete and analysis is now taking place. We look forward to reading the results paper when it’s ready!

MABEL Video live

Following on from our MABEL Study Spotlight, a new patient information video has now been released. It was co-created with our patient and public involvement group at the University of Hull for people who have been recommended to try low-dose morphine for their breathlessness by their doctor. Using clear animation and narration, the video covers living with breathlessness, why morphine might help, how it is taken, and addresses common concerns in an accessible and reassuring way. The messages in the video are consistent with the evidence from the MABEL study.
 
Chronic breathlessness is often disabling despite best treatments of the underlying condition(s) that cause the breathlessness. MABEL tested if regular, low dose morphine capsules regularly twice a day are better than placebo (dummy) ones for chronic breathlessness and whether morphine improves daily activity. It was found that people taking morphine on average completed about 10 more minutes of moderate-vigorous exercise per day. This was a study lead collaboratively by teams at the University of Hull and the University of Edinburgh and was funded by NIHR HTA.

You can watch the video and also read more about the MABEL study here and the video was created by graphic designer Amymadethis.

Other January project headlines:

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HHTU News Roundup

Recruitment milestone reached

We are thrilled to announce that the MOI-A study has successfully reached its UK recruitment target. A major milestone for this important research programme into a rare disease. This achievement is a testament to the dedication and hard work of the research team here at HHTU, the continued support of our Chief Investigator, Professor Nick Bishop, and the commitment of our recruiting sites. A heartfelt thank you also goes to the participants themselves, whose involvement is helping to advance knowledge and future treatments for people living with osteogenesis imperfecta (OI).

The MOI-A (Matrix-Directed Therapy in Older Adolescents and Adults with Osteogenesis Imperfecta) study is being conducted as part of the broader REMEDi4ALL drug repurposing initiative. It is investigating whether the repurposed drug losartan can reduce bone turnover in individuals with OI, a rare inherited condition characterised by bone fragility and associated complications. The trial aims to identify an effective dose of losartan based on its impact on bone resorption markers.

While the UK recruitment target has now been met, recruitment will continue to enable the study to reach its overall aim of 30 participants, in collaboration with our partner sites in Italy.

In addition to this recruitment milestone, the MOI-A study has recently achieved another significant success with its first publication, which can be read here: https://pubmed.ncbi.nlm.nih.gov/41360460/

This publication is the protocol paper which details the plan for the study and outlines the methods and analysis. We look forward to reading future MOI-A related publications in the future.

BREEZE-2 recruitment competition

To boost participant enrolment and encourage engagement across all trial locations,  a Winter Recruitment Competition was launched on BREEZE 2. Each participating site competed to get the highest recruitment numbers from the 1^st November through to the 19^th December end date. The competition took the form of a sledge race down a snowy hill where each site was represented by sledge, and higher recruiting sites were further down the hill. All sites received regular updates of the leaderboard, with a number of sites recruiting several across one or two days. 

The recruitment during the competition was fierce (particularly in November), being amongst the highest recruiting months since recruitment began with a total of 19 participants in the competition bringing the total recruitment for BREEZE 2 to 68 participants. After a close race, the winning sites (Great Yarmouth, Devon and Hull) all recruited 3 participants each and got a hamper of confectionary just in time for Christmas. 

Other December project headlines:

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