A study testing a quality of life questionnaire for women after breast reconstruction

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 to test a quality of life questionnaire for women who have had a breast reconstruction.

Doctors can treat breast cancer with surgery. If you have surgery, you may have your whole breast removed (a mastectomy), followed by surgery to make a new breast shape. This is called breast reconstruction.

Doctors know that this can be an emotional time and they have developed a questionnaire to find out more about how breast reconstruction surgery affects women’s quality of life Open a glossary item .

The aim of this study is to test this new quality of life questionnaire. They want to find out how suitable and reliable it is for women who have breast reconstruction surgery.

You will not get any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the researchers hope it will help them develop a questionnaire that will be useful in the future when planning breast reconstruction surgery.

Who can enter

There are 2 groups of women in this study.

Women in the 1st group are to have their whole breast removed (mastectomy) within the next 6 months.

Women in the 2nd group must have had their mastectomy between1 and 5 years ago and a scan that shows their cancer hasn’t spread to another part of their body.

And as well as the above, you

Had chemotherapy or hormone therapy before your surgery to shrink the cancer
Are going to have radiotherapy after your mastectomy
Are willing and able to answer the questions in the questionnaire

You cannot join this study if any of these apply

Your breast cancer has come back
Your mastectomy was more than 5 years ago
You have had your breast removed as a way of preventing you getting breast cancer

Trial design

This is an international study. The researchers need 360 women to join.

On 2 occasions you spend 10 to15 minutes answering a short questionnaire about your health, and reading statements in the document the study team are developing and indicating which responses best describe how you feel. The statements focus on your thoughts and, or feelings, about your life and your relationships with others since you had your breast reconstruction.

If you haven’t already had your mastectomy, you will fill in the first questionnaire before you have your mastectomy and the second one 6 months afterwards.

If you have already had your mastectomy, you fill in the 2nd questionnaire about 3 weeks after doing the 1st questionnaire. You can fill in the 2nd questionnaire at your clinic appointment or online at home.

Hospital visits

There are no extra hospital visits if you take part in this study. The questionnaire takes about 10 to 15 minutes to do.

Side effects

The study team does not expect there to be any real risks or disadvantages from taking part in this study. But you may find some of statements or questions upsetting. If this happens, you can ask the researcher to put you in touch with someone who can offer you further support.