NEWDAY-ABC

Study Design: Randomised controlled hybrid intervention-implementation trial
Disease Area: Cancer / Breast Cancer
Funder: Yorkshire Cancer Research
Sponsor: University of Hull
Chief Investigator: Prof John Saxton and Dr Caroline Wilson

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

IN SET UP

Summary

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.

What we plan to do

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 Investigator

Prof. John Saxton Professor in Clinical Exercise Physiology - University of Hull

Dr. Caroline Wilson Consultant in Medical Oncology - The Christie NHS Foundation Trust

HHTU Study team

Matthew Northgraves - Trial Manager
Judith Cohen - HHTU Director
Bronwen Williams - Operations Manager
Beccy Acaster - Data Manager
Chao Huang - Statistician

Collaborators

University of Hull
The Christie NHS Foundation Trust
NHS Hull University Teaching Hospitals
Sheffield Teaching Hosptials NHS Trust
Advanced Wellbeing Research Centre - Sheffield Hallam University