
Study Design: Randomised controlled hybrid intervention-implementation trial
Disease Area: Breast Cancer
Funder: Yorkshire Cancer Research
Sponsor: University of Hull
Chief Investigator: Prof John Saxton and Dr Caroline Wilson
Trial registration: TBC
North of England Wellness through healthy fooD choices and ActivitY after early Breast Cancer (NEWDAY-ABC) hybrid intervention-implementation trial
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Project overview
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Trial Team
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Participating Sites
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Patient Information
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Dissemination
Summary
Many people recovering from early-stage breast cancer are above a healthy weight. This can increase the risk of cancer returning and negatively impact long-term health. Eating well, staying active and managing weight may improve recovery and wellbeing. Despite this, there is a lack of lifestyle support offered after treatment.
A programme of support has been developed (the NEWDAY-ABC programme) to help patients recovering from early stage HER2 negative (HER2-ve) breast cancer to achieve a healthy weight and increase their physical activity.
During a small scale study, the programme was found to be acceptable to those involved and potentially helped people to lose weight and reduce their BMI and waist and hip circumference.
We are now conducting a larger study in the North of England that will explore if the NEWDAY-ABC programme can help people recovering from early-stage breast cancer treatment to develop the skills and confidence needed to make healthy lifestyle changes.
What we plan to do
The NEWDAY-ABC trial is a Phase 3, multi-centre, two-arm randomised controlled hybrid intervention-implementation study sponsored by the University of Hull (IRAS ID: 362285). This trial will evaluate a lifestyle intervention in adults with HER2-negative stage II–III early breast cancer. The trial will recruit 375 participants from NHS sites across Yorkshire, Greater Manchester and Cheshire.
The trial aims to demonstrate the effectiveness and cost-effectiveness of the NEWDAY-ABC and facilitate its implementation into the care pathway.
There will be a 9-month internal pilot to assess assumptions on recruitment, retention and fidelity of the intervention
Chief Investigators
Prof. John Saxton Professor in Clinical Exercise Physiology - University of Hull
Dr. Caroline Wilson Consultant in Medical Oncology - The Christie NHS Foundation Trust
NEWDAY-ABC Study team
Dr Ellie Langworthy (Hull)
Dr Claire Williams (Sheffield)
HHTU Study team
Matthew Northgraves - Trial Manager
Judith Cohen - HHTU Director
Bronwen Williams - Operations Manager
Sarah Sumpter - Data Manager
Chao Huang - Statistician
Collaborators
University of Hull
The Christie NHS Foundation Trust
Hull University Teaching Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Trust
Advanced Wellbeing Research Centre - Sheffield Hallam University
Email address
newday@hyms.ac.uk
Participating Sites and their Project Investigators
The Christie NHS Foundation Trust - Dr. Caroline Wilson
Hull University Teaching Hospitals NHS Trust - Dr. Amandeep Dhadda
Sheffield Teaching Hospitals NHS Foundation Trust - Prof. Matthew Winter
The privacy notices for this study are linked below
Watch this space.







