NEWDAY-ABC

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: ISRCTN16294567

North of England Wellness through healthy fooD choices and ActivitY after early Breast Cancer (NEWDAY-ABC) hybrid intervention-implementation trial

RECRUITING

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 (Consultant Clinical Oncologist)

Northern Lincolnshire and Goole NHS Foundation Trust - Dr Annet Pillai (Consultant Medical Oncologist)

Sheffield Teaching Hospitals NHS Foundation Trust - Neil Masters (Consultant Pharmacist Oncology)

NEWDAY-ABC is currently open to recruitment for patients who received their breast cancer treatment at The Christie NHS Foundation Trust and Hull University Teaching Hospitals NHS Trust.

To find out more about the study, you can read the Participant information for open sites below:

MANCHESTER HUB (The Christie NHS Foundation Trust)

Participant Information Sheet (Christie)

NEWDAY-ABC Infographic

NEWDAY-ABC Poster (Christie)

HULL HUB (Hull University Teaching Hospitals NHS Trust)

Participant Information Sheet (Hull)

NEWDAY-ABC Infographic

NEWDAY-ABC Poster (Hull)

For further information you can email NEWDAY@hyms.ac.uk or complete the EOI for the hospital you received your treatment at.

MANCHESTER HUB

For patients of The Christie NHS Foundation Trust