A study looking at improving outcomes for older women with breast cancer

Cancer type:

Breast cancer

Status:

Open

Phase:

Other

This study is looking at using decision making tools to improve treatment outcomes for women aged 70 or older with breast cancer. 

More about this trial

Doctors can treat breast cancer with surgery, radiotherapy, hormone therapy or a combination of these. They depend on research to make sure that every woman gets the treatment that suits her best.

But much of this research is in women under the age of 70. So doctors have much less evidence to guide them about treatments for women over the age of 70. 

In this study researchers developed tools to help older women and their doctors make decisions about breast cancer treatment. These decision making tools are

  • a web page doctors can use during the clinic appointment
  • detailed written information about 2 treatment options for the women
  • 2 tables summarizing the pros and cons of the 2 treatment options

In half of the hospitals where the study is been done the women and their doctors will have the option to use the decision tools or not. In the remaining hospitals the tools won’t be used.   

The main aims of this study are to

  • gather detailed information about the treatment of breast cancer in older women
  • find out how well they do
  • find out how well the decision making tools work
  • find out how many women and doctors use the decision making tools

Who can enter

You may be able to enter this trial if you

  • Are a woman and you were over 70 years old when your breast cancer was diagnosed
  • Have invasive breast cancer that can be removed with surgery

You cannot enter this trial if you

  • Have breast cancer that has spread to another part of your body
  • Cannot have surgery to remove your cancer
  • Have had breast cancer in the past 5 years
  • Are taking medication containing oestrogen, such as hormone replacement therapy (HRT) unless you are able to stop it a month before taking part in this study – your doctor can advise 

Trial design

There are 6 parts in this study. The study team need 3,000 women to join.

First part

You attend your follow up visits as normal. The researchers will record information about how you are doing and what treatment you are having.

For the other parts you can agree to take part in any one, or all, of them if you want to. 

Second part

You fill in a few questionnaires when you attend your follow up visits. These questionnaires will ask about how you have been feeling and side effects you’ve had. This is called a quality of life study.

Third part

The researchers will ask for a sample of tissue from when you had a small piece of tissue (biopsy) taken to diagnose your cancer or have surgery to remove your cancer. They hope these will help them to develop better tests to predict which treatments work best for different women. 

Fourth part

The researchers want to see how you are doing in the long term and if you had any health problems before, during and after your cancer treatment. They want to access your details on 2 registries. The first is the UK National Cancer Registry that keeps details of the number of cancer cases and types each year. The other is the Hospitals Episodes Statistics registry that records all the hospital visits during the year. 

Fifth part

The team may invite you to take part in an interview. They will ask you about the discussions you had with your doctor and nurse about your treatment. And how you decided what treatment was right for you. With your permission they will audio record this.

Sixth part

With your permission the researcher will audio record the discussion you have with your doctor or nurse about your treatment choices.

Hospital visits

You see the doctor 6 weeks after starting treatment and then every 6 months for 2 years for a physical examination and to see how you are.

Side effects

There are no side effects associated with taking part in this study.  

Location

Abergavenny
Airedale
Barnsley
Blackburn
Boston
Bradford
Brighton
Bristol
Burnley
Chelmsford
Cheltenham
Chester
Colchester
Cottingham
Coventry
Coventry
Croydon
Dartford
Doncaster
Dorchester
Epping
Grantham
Grimsby
Harrogate
Kingston upon Thames
Lancaster
Leeds
Leicester
Leighton
Lincoln
Liverpool
Llandough
London
Luton
Macclesfield
Manchester
Mansfield
Middlesbrough
Milton Keynes
Newport
Newport (IOW)
Nottingham
Oxford
Prescot
Rotherham
Scarborough
Scunthorpe
Sheffield
Southport
Stockton-on-Tees
Tameside
Wakefield
West Bromwich
Weston Super Mare
Wigan
Yeovil
York

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Lynda Wyld

Supported by

NIHR Clinical Research Network: Cancer
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Sheffield Hallam University
Sheffield University

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10794

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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