“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study to see if information about risk affects whether women follow a weight loss programme (PROCAS lifestyle study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at personalised information about risk, and whether it increases the number of women who are able to follow a diet and exercise weight loss programme.
The women joining this study are already taking part in the main PROCAS study. PROCAS is a very large study collecting information about breast cancer risk from women taking part in the NHS breast cancer screening programme.
The researchers have estimated the risk of breast cancer for 55,000 women in the PROCAS study. They found that
- About 1 in 100 women have a high risk (about 30% chance of developing breast cancer in their lifetime)
- 9 in 100 women have a moderately increased risk (between 20% and 30%)
- 70 in 100 women have an average risk (between 4% and 20%)
- 20 in 100 women have a below average risk (less than 4% chance of developing breast cancer)
If you are overweight, losing weight (and keeping the weight off) can reduce your risk of getting breast cancer. It can also significantly reduce your risk of diabetes, heart disease and stroke.
In this study, the researchers are looking at whether they can target women in the NHS breast screening programme and introduce lifestyle changes that can reduce their risk of cancer and other diseases.
The study team aim to find out
- If they can get overweight women to join a weight loss programme
- Whether the level of breast cancer risk influences how many women join the programme and stick to it
- If women in the breast cancer screening programme have increased risks of other cancers, diabetes, heart disease, stroke and dementia, and whether they have concerns about these
- Whether a web based diet and exercise programme can help women to lose weight
The results of the study will be used to plan a large clinical trial that will test a tailored weight loss programme to see if it works, whether it will reduce breast cancer risk and what it will cost.
Who can enter
You may be able to join this study if all of the following apply. You
- Have recently received your breast cancer risk feedback from the PROCAS study
- Are overweight with a
body mass index (BMI)of 25 or more
- Live within travelling distance of the Nightingale Centre and Genesis Prevention Centre in Manchester
- Have access to a phone and the internet and are able to use both of these
You cannot join this study if any of these apply. You
- Have had cancer (apart from carcinoma in situ of the cervix or non melanoma skin cancer)
- Have diabetes or disease of the heart or blood vessels (
- Have serious kidney problems
- Have any medical condition or mental health problem that could affect you taking part
- Currently use hormone replacement therapy (
- Are successfully following a diet or exercise plan and have lost more than 2lb (1kg) of weight in the last 2 weeks
- Women in group 1 receive information about their personal risk of getting breast cancer, heart disease, stroke, diabetes and dementia.
- Women in group 2 receive information about their personal risk of getting breast cancer and general information about heart disease, stroke, diabetes and dementia.
Everybody taking part will use the study’s interactive website and have 3 months of personalised phone and online support in making lifestyle changes. This will be followed by 3 more months of using the website with just online support.
Everybody taking part will have an assessment appointment at the Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital.
You then join a weight loss and lifestyle programme with the aim of losing weight over the next 6 months.
For the first 3 months, you use the study website and have telephone and online support from a
There are no side effects associated with taking part in this study.
How to join a clinical trial
Dr Michelle Harvie
Genesis Breast Cancer Prevention Centre
NIHR Clinical Research Network: Cancer
University Hospital of South Manchester NHS Foundation Trust