IMPACTOR
Research type
Research Study
Full title
Impact of abemaciclib on patients’ roles and responsibilities (IMPACTOR)
IRAS ID
279088
Contact name
Valerie Shilling
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research:
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, what steps they may take to reduce it (e.g. dietary changes, over the counter or prescribed medications), and whether this side-effect improves with 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.Research Summary:
The IMPACTOR study (IMPact of AbemaCiclib on patienTs’ rOles and Responsibilities) ran from September 2020 to March 2023.Study background:
The purpose of the study was to investigate people’s experiences of living with metastatic breast cancer and receiving abemaciclib as part of their treatment, alongside either fulvestrant or an aromatase inhibitor. We wanted to understand the real-world impacts of this. Up until now, insights about this treatment came from clinical trial data. This can be somewhat limited and restricted to the experience of eligible patients, who may differ from those not in a trial.Aims:
Our main aim was to track any change to quality of life scores and the impact on people’s ability to fulfil their day-to-day roles and responsibilities. These were both measured by questionnaires.A secondary aim was to provide descriptive detail about these experiences, captured by optional interviews with participants. We were also interested in exploring whether abemaciclib related diarrhoea was well managed and whether its intensity changed over time. This was captured with self-report diaries.
Recruitment:
We recruited 46 women to take part, though 2 people withdrew after consent. The age range of the remaining 44 participants was between 42 and 83. Twenty-four participants remained on study for the full 6 months. Others withdrew as they stopped treatment, either due to side effects or a progression of their cancer.Assessments and timepoints:
Participants took part in the study for 25 weeks/6 months. They completed diarrhoea diaries each week and quality of life questionnaires when joining the study and then one, three and six months later. Participants were given the option of taking part in a one-off telephone interview. Twenty women opted to do so.Findings:
Participants experienced a change in their bowel habits while on abemaciclib – with a range of 0 – 8+ daily stools between the baseline and first month timepoints. Clinical classifications for diarrhoea are often defined by high frequency and loose/watery bowel movements. When we applied this approach to the diarrhoea diaries, we found that between 10 – 24% (1 – 2 in every 10) of participants experienced diarrhoea at any given timepoint. Three people reported diarrhoea which was persisted across at least 23 of the timepoints. Seventeen people (40% or 4 in 10 women) did not report any diarrhoea while on study.However, while some participants didn’t meet clinical criteria for diarrhoea, we did see anecdotal data to suggest people were experiencing changes in bowel habits. This was evident as 70% of participants (7 in 10 women) reported using self-management strategies to control diarrhoea within the first 3 months of study. The main methods were making dietary changes (50% or 1 in 2 women) or taking medication to help stop diarrhoea or loose stools (30% or 1 in 3 women).
Half of our participants (50% or 1 in 2 women) reported treatment breaks and dose reductions. Some people skipped doses of the abemaciclib as well to self-manage symptoms.
Quality of life scores for the group did not change significantly over time however we must be careful interpreting this finding because it only includes people who stayed on the study until the end. This means it is based on a small number of people who were well enough to finish the study and who stayed on treatment. We also looked at individual change, rather than the group as a whole. Most people reported no change or sometimes improvement in areas of quality of life compared to the start of the study. However, a marked number of participants experienced a meaningful decline in quality of life during the study (by month 1 - 15/37 – 40% or 4 in 10 women, month 3 – 9/28 – 32% or about 3 in 10 women, month 6 – 9/23 – 39% or about 4 in 10 women).
The interviews we conducted helped to shed some light on these experiences. In our analysis of these, we developed 8 main themes which recurred across our transcripts. Predominant amongst these were the themes of side effects and side effect management. People were willing to tolerate a level of discomfort in the belief that the treatment was helping them. They often spoke about how bad things would have to be in order to consider stopping.
The interviews aligned with the diarrhoea diaries in that people tried to manage side effects using diet and medication, such as loperamide. They also spoke about changing where and what time they would go out, ensuring there were nearby bathrooms to avoid any accidents, or carrying additional cleaning supplies with them.
Benefits and limitations:
We originally aimed to recruit 150 participants but this target was not achieved. As a result, we were not able to carry out some of our analyses. However, we did complete the number of interviews we had planned.A combination of the questionnaire, diary and interview data gave us a picture of what it was like being on treatment with abemaciclib for our participants. This experience differs from some clinical criteria – such as what counts as diarrhoea. Steps could be taken to improve education around this and to help provide information to those taking the drug as to how they could manage this side effect, and others.
We noted that participants felt isolated on this treatment as there weren’t many other people they could turn to who were also taking abemaciclib. Again, additional resources could be created to allow a community of patients to learn from each other and aid this feeling of being alone.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0101
Date of REC Opinion
17 Apr 2020
REC opinion
Favourable Opinion