A study of the effect abemaciclib has on the daily life of people who take it (IMPACTOR)

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 effect abemaciclib might have on your quality of life and daily roles and responsibilities.

More about this trial

Abemaciclib is a treatment for certain types of breast cancer that has spread. You have abemaciclib in combination with fulvestrant or an aromatase inhibitor Open a glossary item .

Before they become available as a treatment all drugs go through a clinical trial Open a glossary item . As part of the clinical trial researchers also look at how the drug might affect people’s quality of life.

But in a clinical trial there are several conditions on who can or cannot take part. And so this does not give a true picture of how treatment might affect the quality of life for people in the real world.

In this study researchers ask women who are taking abemaciclib to fill in some questionnaires. The questions asked are about:

your general quality of life
symptoms and side effects
how you are managing your day to day roles and responsibilities

They also want to interview some women to find out more about this.

The aims of the study are to find out:

what is the experience of women taking abemaciclib outside of a clinical trial
how abemaciclib affects quality of life
how abemaciclib affects the roles and responsibilities of women taking it

Who can enter

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

Please note
Your doctor must contact the study team before you begin treatment with abemaciclib.

Who can take part

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

have breast cancer that has spread to the nearby tissue (locally advanced ) or has spread to another part of the body (metastatic)
are about to begin treatment with abemaciclib in combination with fulvestrant or abemaciclib in combination with an aromatase inhibitor
are able to speak and read English
are at least 18 years old

Who can’t take part

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

have another cancer other than breast cancer
are being treated or about to begin a treatment that doesn’t include abemaciclib
have already started treatment with abemaciclib
are in hospital

Trial design

The study team want 150 people to take part.

You fill in a questionnaire booklet:

when you join the study then at
1 month
3 months
6 months

The questions ask about:

your general quality of life
symptoms and side effects of your treatment
how you are managing your day to day roles and responsibilities. This includes things like caring for family members and returning to work.
managing personal finances, such as the additional costs of illness or cutting back on some things

The questionnaire booklet takes about 20 minutes to complete.

You can do the questionnaires online. The team send you a weblink each time you are due to do the questionnaires.

Or if you prefer, they will send you a paper copy of the questionnaires to fill in and send back. They will provide a stamped addressed envelope for its return.

Abemaciclib can cause diarrhoea. The study team give you a weekly diarrhoea management diary to fill in. This takes about 5 minutes each week.

Interviews
The team want to interview up to 50 people.

When you receive your 3 month questionnaire the team will invite you to an interview. You don’t have to agree to do the interview. You can still do the questionnaires.

But if you do agree, the team will arrange it at a time and date to suit you. The interview is over the phone.

They ask about:

the positive and negative affect abemaciclib has on your life
side effects you have
how you cope with the side effects
what you do to relieve the side effects

The interview is audio taped so the researchers record your answers. They can write these out later. Your answers are confidential.

Hospital visits

There are no extra hospital visits if you agree to take part.

Side effects

Thinking about cancer and treatment might upset you. Should this happen you can contact a member of the study team. Or if you prefer you can contact the Patient Advice Liaison Service (PALS) at your hospital.