HHTU News Roundup

NEWDAY ABC pilot study paper published

The results paper for the NEWDAY ABC pilot study was published in Pilot and Feasibility Studies (https://doi.org/10.1186/s40814-025-01689-3) in August. The NEWDAY-ABC assessed the feasibility of a co-designed weight loss intervention versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients. The study was set-up at the start of the pandemic, which presented challenges but intervention was found to be feasible and potentially showed benefit in aiding weight loss and other important health outcomes in women with early-stage breast cancer. A full multicentre randomized controlled trial of the NEWDAY-ABC will start in 2026.

SPOTLIGHT SERIES
02: The BREEZE-2 study

Idiopathic pulmonary fibrosis (IPF) and other fibrotic-interstitial lung diseases, collectively termed pulmonary fibrosis (PF), are progressive, incurable and ultimately fatal. Although two therapies are now available that slow the rate of lung function decline, they have failed to show improvement in symptoms or quality of life. There is limited evidence relating to the efficacy of breathlessness management in people with PF. The poor prognosis, variable disease trajectory and absence of any existing, widely accessible evidence-based treatment to improve patients’ symptoms sets PF apart from other causes of chronic breathlessness

Trial Design

Multi-centre, wait-list design, randomised, controlled trial of a complex, non-pharmacological breathlessness management intervention in people with pulmonary fibrosis (PF) and chronic breathlessness, with embedded qualitative implementation study to inform scaled NHS adoption.

Leadership and collaboration

The study is led by Dr Ann Hutchinson and coordinated by the Hull Health Trials Unit. The Hull Health Trials Unit team is expertly lead by Trial Manager Grant Constable and Data Manager Philip Best.

study progress

The study launched earlier this year, with 14 sites now open and actively recruiting participants. The final 15th site is underway with site set-up and we hope to get them open to recruitment within September.

To date, BREEZE 2 has successfully enrolled 34 participants across nine sites:

· Hull University Teaching Hospitals NHS Trust
· Manchester University NHS Foundation Trust
· NHS Lothian (Edinburgh)
· The Royal Wolverhampton NHS Trust
· Royal Devon University Healthcare NHS Foundation Trust
· University Hospitals of Leicester NHS Trust
· University Hospital Southampton NHS Foundation Trust
· James Paget University Hospitals NHS Foundation Trust
· Western HSC Trust (Northern Ireland)

We sincerely thank all our participating sites for their ongoing commitment and collaboration in driving this vital research forward.

impact and outlook

This study will allow us to test the clinical and cost effectiveness of a complex intervention to manage breathlessness and for us to understand how best to implement the intervention if found to be effective.