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Contact Information:

Prof John Saxton
+44 (0)191 227 3371
john.saxton@northumbria.ac.uk


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Be Part of Research - Trial Details - North of England women's diet and activity after breast cancer randomised controlled trial
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North of England women's diet and activity after breast cancer randomised controlled trial

Not Recruiting

Open to: Female

Age: Adult

Sheffield Newcastle-upon-Tyne North Shields Newcastle Gateshead Sheffield

Medical Conditions

Breast cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Being overweight after hormone-positive breast cancer treatment increases the chance of cancer returning: extra weight (mainly fat) leads to higher levels of oestrogen/harmful substances in the blood. There is a lack of lifestyle support for overweight women after breast cancer. This study has designed a practical way to provide individually tailored lifestyle support to help them lose weight. This overall project has three phases, the first phase of which has already been completed, working with patients and clinicians to develop an intervention. The second and third phases are to complete the internal pilot of this intervention to test the feasibility of the study before going into the full trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2021 30 Sep 2021

Participants are randomly allocated to either the control or the intervention group. Participants allocated to the control group are asked to attend the initial assessment session and follow-up assessment sessions after 6 and 12 months. They continue to receive usual care from their healthcare provider and on completion of the 12-month assessment session, receive all the intervention materials that are given to participants in the intervention group.
Participants allocated to the intervention group attend an initial support session and attend support sessions over 12 months. These workshops offer healthy lifestyle (dietary and physical activity) education; support for the different ways to can engage in physical activity; provide an opportunity for discussion and resolving personal challenges; and help through the weight loss journey. After the first 3 months in the support group, the lifestyle advisor contacts the participant at regular intervals either by telephone or email (participant choice) to provide individual ongoing support.
All participants complete baseline, 6 and 12 months testing carried out by members of the research team who are blinded to group allocation. These sessions collect all outcome measures. Participants are also contacted by a researcher at 3, 6, 9 and 12 months to ask about their healthcare resource use.
A process evaluation is ongoing throughout the study. This evaluation includes interviewing lifestyle advisors leading the group sessions, interviewing participants at different timepoints and observing group sessions.


Overweight and obese women diagnosed with early-stage, oestrogen-positive breast cancer and are at least 8 weeks from any final chemotherapy and less than 3 years since primary treatment was completed. Women are required to be under the care of one of the four participating NHS Trusts.

You can take part if:



You may not be able to take part if:


1. Metastatic/inoperable or active loco-regional disease; BMI < 25kg/m22. Following alternative/complementary diet or taking high dose antioxidants for >= 3 months3. Severe physical/psychiatric or comorbid impairment (e.g. arthritis/multiple sclerosis)4. Uncontrolled T2DM and CVD or severe osteoporosis5. No telephone contact6. Unable to consent7. Enrolled on another weight loss/lifestyle behaviour change trial8. Already engaged in > 150 min.week-1 of moderate-intensity PA9. Expecting to have surgery during the study that would affect adherence to the study10. Unable to speak/read English


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sheffield Teaching Hospitals NHS Foundation Trust
    Northern General Hospital Herries Road
    Sheffield
    S5 7AU
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle-upon-Tyne
    NE7 7DN
  • Northumbria Healthcare NHS Foundation Trust
    Rake Lane
    North Shields
    NE29 8NH
  • Northumbria University
    Department of Sport, Exercise and Rehabilitation Northumberland Building City
    Newcastle
    NE1 8ST
  • Gateshead Health NHS Foundation Trust
    Queen Elizabeth Hospital
    Gateshead
    NE9 6SX
  • Sheffield Hallam University
    Advanced Wellbeing Research Centre Collegiate Cresent
    Sheffield
    S10 2LX

Women allocated to the intervention group receive information and support regarding diet and physical activity to achieve and maintain weight loss and improve general level of fitness. This programme of support for lifestyle behaviour change has been specifically designed for breast cancer patients. The intervention will also inform the participants of the latest evidence-based guidance on dealing with possible side-effects that they might be experiencing. By decreasing weight and becoming more physically active, current scientific evidence suggests that improvements in the quality of cancer survivorship experience, as well as decreasing risk of future health conditions, including breast cancer recurrence, diabetes and cardiovascular problems. Intervention groups involve a physical activity component, which could lead to some muscle soreness or risk of injury. These sessions will be progressive and be taken by a qualified cancer-rehabilitation exercise instructor to ensure these risks are minimal. All participants complete up to three Dual Energy X-ray (DXA) scans. All of these will be extra to those that they would receive if they did not take part. These scans provide clinical information. The x-ray procedures use ionising radiation to form images of the body. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chance of this happening as a consequence of taking part in this study is extremely small.

Prof John Saxton
+44 (0)191 227 3371
john.saxton@northumbria.ac.uk



The study is sponsored by Northumbria University and funded by Yorkshire Cancer Research; Grant Codes: NOR416; National Institute for Health Research (NIHR) (UK).



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Read full details for Trial ID: ISRCTN15088551

Or CPMS 44178

Last updated 20 September 2021

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