A study to improve people’s understanding of a test for gene activity in breast cancer (IMPARTER)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 4

This study is looking at whether people better understand gene profiling tests after watching a video about it. This is when they compare to the standard information they might receive about the gene profiling tests.

It is open to people who are already having a genetic profiling test.

More about this trial

The gene expression profiling (GEP) test looks at individual cancers to understand how they behave. Doctors use the GEP test to decide what combination of treatment might help stop your breast cancer coming back after surgery.

Researchers have made a short film about GEP tests. They want to find out whether this film might help people better understand what these tests are.

In this study half the people will:

get the standard information from the hospital only
watch the film and get the standard information from the hospital

The main aim of this study is to find out whether the film increases people’s knowledge and understanding of GEP testing.

Please note you won’t get any direct benefit from taking part in this study. The information you give might help the team improve information people get about GEP tests.

Who can enter

The following bullet points are a summary of 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:

have agreed to have gene expression profiling testing
have a good understanding of English
have access to the internet such as a smartphone, laptop, tablet or desktop computer
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have breast cancer that is not early stage such as DCIS and cancer that has spread to another part of the body
have a clear decision from your doctor that you should have chemotherapy

Trial design

This is a phase 4 trial. The study team need 250 people to join.

It is a randomised Open a glossary item study. A computer puts you into a group. Neither you nor the research team chooses which group you are in. There are 2 groups:

standard information about GEP testing provided by the hospital. Your doctor or nurse might tell you about the test, give an information sheet or show you online information about GEP. (Group A)
watching the film and getting the standard information (Group B)

When you see your doctor or nurse they might mention the study to you. They will then send your contact details to the study team if you are interested.

A member of the team will call you. They tell you about the study and answer any questions you have.

The team contacts you 5 times.

The first 2 times are before the team puts you into one of the groups. They:

call you to talk about the study, answer any questions you may have and receive verbal consent from you if you would like to take part. They will also arrange another call. This call will be at a time and date convenient to you in the week before getting your results.
email a web link to you. This has a consent form and 3 short questionnaires for you to complete. The questions ask about how you are feeling and how you make decisions. This takes about 10 to 15 minutes to do.

You go in to either Group A or Group B. The team e-mail you to tell which group you are in. They will send people in Group B a web link to watch the film. The film is 8 minutes long.

The team then contact you twice more.

The first contact is a phone call. They will call you at a time and date convenient to you. During the call they ask you what you understand about the GEP test. They also ask you about how useful the information was. They write down your answers. They use your answers to improve the information about GEP testing.

The second contact is an email. This will have a web link to 2 questionnaires. This is sent to you the day of your GEP results appointment to complete within a week.