
Study Design: External Pilot Randomised Controlled Trial
Disease Area: Cancer / Breast Cancer
Funder: Yorkshire Cancer Research
Sponsor: Northumbria University
Chief Investigator: Prof John Saxton and Dr Caroline Wilson
Trial Registration: ISRCTN15088551
North of England Women’s Diet and Activity After Breast Cancer
(NEWDAY-ABC) – Pilot RCT
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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
In the UK, studies have reported a range of health benefits following interventions to increase physical activity and improve dietary behaviours, also known as lifestyle behaviour changes after primary treatment of early-stage breast cancer.
Identified barriers to positive lifestyle behaviour change include a lack of motivation, fears about cancer recurrence, physical factors such as common physical side effects of breast cancer treatment (fatigue, lymphoedema, weight gain), the ageing process and contextual/environmental factors such as employment and access to exercise facilities.
In contrast, facilitators for positive lifestyle behaviour change include a desire to lose weight, access to supervised exercise and dietary education, feeling a sense of control, peer support and having an opportunity to regain a sense of normality.
Despite these study findings, breast cancer patients consistently report a lack of accurate information and/or support from health professionals, including accurate lifestyle advice for people living with treatment-induced physical limitations. Offering a route to supported, personalised lifestyle behaviour change interventions could address an important unmet need for women and provide treating clinicians with well-defined advice and guidance at this opportune ‘teachable moment’.
What we plan to do
Through qualitative work, a team of researchers from Northumbria University have developed a lifestyle behaviour change intervention for overweight women following primary treatment of early stage breast cancer.
The intervention will now be tested in a multi-centre, randomised controlled superiority trial. An external pilot trial will assess the feasibility and acceptability of the NEWDAY-ABC intervention and assess the recruitment and retention assumptions.
In collaboration with Northumbria University, Hull Health Trials Unit are responsible for trial management and data management systems for the NEWDAY-ABC study.
Chief Investigator
Prof John Saxton Professor in Clinical Exercise Physiology - University of Hull
Dr Caroline Wilson Oncologist - Sheffield Teaching Hospitals
HHTU Study team
Matthew Northgraves - Trial Manager
Bronwen Williams - Operations Manager
Sarah Sumpter - Senior Data Manager
Judith Cohen - Director
John Turgoose - Information Systems Manager
Collaborators
Dr Sarah Wane Researcher - Northumbria University
Dr Katie Pickering Researcher - Sheffield Hallam University
Email address
hhtuenquiries@hyms.ac.uk
Participating Sites and their Project Investigators
- Sheffield Teaching Hospitals NHS Fundation Trust Dr Caroline Wilson
- Gateshead Health NHS Foundation Trust Dr Daniela Lee
- Northumbria Healthcare NHS Foundation Trust Dr Wendy Carr
Publications
Saxton, J. M., Pickering, K., Wane, S., Humphreys, H., Crank, H., Anderson, A. S., Cain, H., Cohen, J., Copeland, R. J., Gray, J., Hargreaves, J., McNally, R. J. Q., & Wilson, C. (2022). Co-designed weight management intervention for women recovering from oestrogen-receptor positive breast cancer. BMC Cancer, 22(1), 1202. https://doi.org/10.1186/s12885-022-10287-y
Jm, S., K, P., S, W., H, C., As, A., H, C., J, C., Rj, C., J, G., J, H., Rjq, M., & C, W. (2022). The experiences and perceptions of female breast cancer patients regarding weight management during and after treatment for oestrogen-receptor positive disease: a qualitative study. BMC Cancer, 22(1), 1189. https://doi.org/10.1186/s12885-022-10238-7
Conference Presentations
Pickering, K., Wane, S., Speake, H., Crank, H., Anderson, A., Cain, H., Copeland, R., Lee D., Gray, J., McNally, R., Hargreaves, J., Cohen, J., Northgraves, M., Wilson, C., Saxton, J (2021) Abstract PS8-26: The new normal; adjusting to remote ways of providing bespoke weight management support to breast cancer survivors during the COVID-19 global pandemic [Poster presentation]. San Antonio Breast Cancer Symposium 2021, San Antonio, Texas. Published in Cancer research Vol. 81, Issue 4_Supplement, pages PS8-26 - PS8-26 https://doi.org/10.1158/1538-7445.SABCS20-PS8-26