Chief Investigators: Professor Dame Lesley Fallowfield

Co Investigator: Dr Valerie Shilling

Researchers: Dr Helena Harder, Rachel Starkings

Data Manager: Shirley May

Impact of abemaciclib on patients’ roles and responsibilities (Impactor)

In this study we will be looking at quality of life (QoL) in women starting abemaciclib treatment for locally advanced or metastatic breast cancer. Often QoL is studied as part of a clinical trial but research has shown that the participants in clinical trials are not always like people taking the treatment in the ‘real world’. This is because clinical trials often need to control for lots of factors, such as age or having other medical conditions. In the IMPACTOR study, we will look at the impact of abemaciclib for women outside of a clinical trial; how treatment might affect their QoL and ability to maintain or return to their normal activities, roles and responsibilities.

We will ask 150 participants to complete questionnaires measuring general health-related QoL, endocrine symptoms (e.g. hot flushes) and side effects associated with abemaciclib such as diarrhoea. They will also complete a questionnaire measuring ability to maintain or return to normal roles and responsibilities; things like caring for family members, returning to work and managing financial responsibilities. We will ask them to complete these measures before starting treatment and after one, three and six months. This will enable us to track any changes in QoL over time. Participants will also keep a weekly diarrhoea diary, as diarrhoea is a common side-effect of abemaciclib. This will help us track whether or not they experience diarrhoea during the study, what steps they may take to reduce it (e.g. changing diet), and whether diarrhoea reduces with increased time on treatment.

We will also invite some participants to take part in an interview study to explore in more depth peoples’ experiences of treatment and side effects, the impact on different areas of their lives, and how they and their healthcare professionals have tried to manage any problems.

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