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North of England Women’s Diet and ActivitY After Breast Cancer Trial (NEW DAY-ABC)

People Involved

Profile image of Mr John Turgoose

Mr John Turgoose J.Turgoose@hull.ac.uk
Information Systems Manager - Hull Health Trials Unit

Project Description

This project is part of a larger consortium which involves University of Northumbria at Newcastle; Sheffield Hallam, Newcastle Hospital NHS Foundation Trust; Sheffield NHS Trust; Universities of Newcastle and Dundee.

The aim for this project is to develop a sustainable intervention model that overcomes NHS implementation challenges and brings about the step-change improvement in personalised support for dietary and physical activity behaviour change that many women need after treatment for ER+ve breast cancer. We have now developed an intervention through a codesign process with patients and health care professionals. Due to delays incurred during the first, co-design phase of this project, this 8-month extension will allow completion of the
planned internal pilot RCT. This pilot will seek to test the feasibility of the intervention before we progress to a fully-powered randomised controlled trial.

Furthermore, due to the complex nature of the trial, this extension allows us to engage Clinical Trials Unit support earlier than initially planned. By engaging Hull Health Trials Unit (HHTU) earlier, we received their support during preparations for Phase 2, which has ensured that the study protocol and all procedures (including data management systems) are set-up for a smooth transition to Phase 3 (the fully powered trial). The HHTU are also providing Trial Manager and Data Manager support to get the pilot up and running, and will continue to provide support throughout the pilot phase.

Project Acronym NEW DAY-ABC
Status Project Complete
Value £38,759.00
Project Dates Nov 5, 2019 - Sep 30, 2021

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