A study of the health of women after breast surgery and radiotherapy (OSTaRa)

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 looking at the health of women who have had surgery to remove a lump followed by radiotherapy.

Surgery to remove the lump is called a lumpectomy or breast conserving surgery.

More about this trial

It is important to make sure all treatments:

are safe
work
are affordable

To find this out researchers use questionnaires that look at how your treatment has affected your quality of life.

At the moment there is little information about women’s quality of life who have had a lumpectomy followed by surgery.

In this study researchers will ask these women to fill in 2 questionnaires:

a quality of life questionnaire
a questionnaire asking about such things as their age, education and employment

The aim of this study is to find out about the quality of life and health of these women after treatment.

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.

Who can take part

You may be able to join this study if all of the following apply. You are a woman who:

has had breast cancer
has had surgery to remove the area of cancer only (lumpectomy or breast conserving surgery)
has had radiotherapy
is at least 18 years old

Who can’t take part

You cannot join this study if any of the following apply. You:

have already filled in an OSTaRa questionnaire
don’t understand English well enough to answer the questions

Trial design

This is an observational study. The study team need 200 women to join.

You will be given an OSTaRa pack when you go to your clinic. The pack contains:

an information sheet
2 questionnaires

After reading the information if you want to join the study, you fill in a consent form.

You then fill in 2 questionnaires. They take about 10 minutes each. You can complete them at the hospital and hand them in before you leave. Or you can take them home and post them back using the stamped addressed envelope enclosed.

The 1st questionnaire asks about your general health and quality of life.

The 2nd questionnaire asks about personal details such as your:

age
employment
education

Hospital visits

There are no extra hospital visits if you agree to join this study

Side effects

Some of questions ask about your cancer and treatment. And this might cause some anxiety.

Recruitment start:

01/03/2019

Recruitment end:

31/03/2020

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Professor Jayant Vaidya

Supported by

University College London

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

31 March 2020

CRUK internal database number:

16362