A study looking at a new way to help women decide about breast reconstructive surgery (PEGASUS)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is using a discussion to help women decide about breast reconstructive surgery.     

It is for women who are thinking about having breast reconstructive surgery following a mastectomy Open a glossary item.

More about this trial

Most women have the choice of having breast reconstructive surgery following a mastectomy. This creates a breast similar in the size and shape of your own breast. 

But the reconstructed breast may not be identical. And you may notice the differences when you are undressed.

You can choose to have the breast reconstructed at the same time of your mastectomy. Or at a later date.

Doctors and nurses can support and help you to make these decisions. But it can be difficult to choose. And you may find it difficult to talk to your doctor about what your expectations are.

The researchers in this trial have developed a new tool to help women making these decisions. It is called PEGASUS (Patient’s Expectations and Goals: Assisting Shared Understanding of Surgery).

The PEGASUS tool is an intervention. It asks about:

  • how you feel about your breasts 
  • your expectations of the reconstruction surgery  
  • how important the surgery is for you

You have this discussion with a member of the breast reconstruction team. 

The main aims of this study are to:

  • find out how good the PEGASUS tool is at helping women decide about breast reconstruction surgery 
  • find out what women and health professionals think about the PEGASUS tool

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this study if you are a woman and all the following apply.

  • You have breast cancer, ductal carcinoma in situ (DCIS), or you are thinking of having a mastectomy to reduce your risk of breast cancer (risk reducing mastectomy) 
  • You are thinking about having breast reconstructive surgery following a mastectomy    
  • You are aged 18 years or older

You cannot join this study if you can’t have breast reconstructive surgery for any reason. 

Trial design

The researchers need about 180 women from the south west of England to take part.

This trial has 2 groups:

  • control group Open a glossary item
  • PEGASUS group

Control group
The first 90 women taking part in this trial go into the control group. 

You complete questionnaires before the breast reconstruction surgery and then after:

  • 3 months
  • 6 months 
  • 12 months

It asks about how you feel about your breasts and the surgery. 

The study team will send you the questionnaires in the post. Along with a prepaid envelope for you to return them. You can also complete them online. Each questionnaire should take around 20 minutes to complete.   

PEGASUS group 
Researchers need about 90 women to take part in this group. 

You complete a questionnaire. It asks about how you feel about your breasts and the surgery.

Then you have a discussion with the breast reconstruction team. This is part of your standard care. During this appointment you complete the PEGASUS intervention. 

It asks you to think about and discuss the surgery. And to write down your goals and expectations for the surgery.

The breast reconstruction team discuss your responses with you. 

They also ask to audio record the discussion. This is for the study team to see how health professionals use the new PEGASUS intervention. They only keep these recordings for the time of the study.

You don’t have to agree to have your discussion recorded if you don’t want to. You can still take part in this study. 

You complete more questionnaires after:

  • 3 months 
  • 6 months
  • 12 months 

It asks you the same questions about how you feel about your breasts and the surgery. 

The study team will send you the questionnaires in the post. Along with a prepaid envelope for you to return them. Or you can complete them online. Each questionnaire should take around 20 minutes to complete.   

Interview
The study team need about 32 women to have an interview around 12 months after surgery. It can be over the telephone or at the hospital. They ask about:

  • what were your expectations for the surgery 
  • how you felt about making decisions about the reconstruction surgery 
  • how you feel about the PEGASUS tool (if you were part of the group using this)

The study team will ask to audio record the interview. Or to complete a written record. They only keep these records during the study. 

Medical records 
The study team will ask to look at your medical records. They want to find out about your surgery and other hospital visits you may have. 

Only people involved in this research will look at your records. 

Hospital visits

You don’t have any extra visits as part of this study. Your discussion with the breast reconstruction team may take longer if you are part of the PEGASUS group. 

Side effects

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

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

Professor Diana Harcourt

Supported by

Breast Cancer Now
University of the West of England

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14106

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

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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