“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A study of the effect abemaciclib has on the daily life of people who take it (IMPACTOR)
This study is looking at the effect abemaciclib might have on your quality of life and daily roles and responsibilities.
More about this trial
Before they become available as a treatment all drugs go through a
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.
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
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.
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.
There are no extra hospital visits if you agree to take part.
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.
How to join a clinical trial
Professor Dame Lesley Fallowfield
Eli Lilly and Company Limited
Brighton & Sussex Medical School
University of Sussex