Patients’ expectations and experiences of abemaciclib and hormone therapy for early-stage high-risk breast cancer
| ISRCTN | ISRCTN10597735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10597735 |
| IRAS number | 298216 |
| Secondary identifying numbers | IRAS 298216, CPMS 49884 |
- Submission date
- 05/10/2021
- Registration date
- 06/10/2021
- Last edited
- 14/12/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is looking at the expectations and experiences of women who are receiving abemaciclib (also called Verzenios) and hormone therapy for early breast high-risk cancer. Abemaciclib is called a targeted therapy. These targeted cancer drugs are treatments that help the body to control the growth and spread of cancer. They focus on specific abnormalities within cancer cells that allow them to survive. When used in breast cancer, abemaciclib is taken together with hormone therapy (also called endocrine therapy).
Treatment with abemaciclib and endocrine therapy for women with early-stage breast cancer that is at high risk of recurrence (returning) is fairly new. Little is known about what patients expect, their experiences during treatment and how they manage any possible side effects. It is known for example that diarrhoea is a common side effect of abemaciclib and can sometimes be severe. Diarrhoea usually starts during the first weeks of treatment. Finding out how people experience treatment, how well they deal with any problems and understanding their needs, is essential to aid the development of helpful information materials that will best inform and support them.
Who can participate?
Patients aged 18 years and over with breast cancer who are postmenopausal and are participating in the POETIC-A trial and allocated to receive abemaciclib and standard hormone therapy
What does the study involve?
Patients take part in a series of three interviews with researchers. They will be interviewed before starting treatment to find out what their expectations are and what they know about the drugs they have been prescribed. The follow-up interviews will take place 4 and 8 weeks later to find out if their treatment experiences met their expectations, if they experienced side effects, especially diarrhoea, what steps they have taken to reduce it, and how successful this was.
What are the possible benefits and risks of participating?
There are no direct benefits of taking part in this study, but the research findings might benefit others in the future. The results of the study will help to get a better understanding of how treatment with abemaciclib and hormone therapy affects people. This will be used to provide the best information and support for others starting this treatment in the future.
Where is the study run from?
Sussex Health Outcomes Research & Education in Cancer (SHORE-C) and Brighton & Sussex Medical School (UK)
When is the study starting and how long is it expected to run for?
July 2021 to August 2023
Who is funding the study?
Eli Lilly and Company Limited (USA)
Who is the main contact?
Dr Helena Harder
h.harder@sussex.ac.uk
Contact information
Scientific
Sussex Health Outcomes Research and Education in Cancer (SHORE-C)
Brighton & Sussex Medical School
University of Sussex
Brighton
BN1 9RX
United Kingdom
| Phone | +44 (0)1273 873019 |
|---|---|
| L.J.Fallowfield@sussex.ac.uk |
Public
Sussex Health Outcomes Research and Education in Cancer (SHORE-C)
Brighton & Sussex Medical School
University of Sussex
Brighton
BN1 9RX
United Kingdom
 ORCID ID |
0000-0002-7296-8227 |
|---|---|
| Phone | +44 (0)12730 873029 |
| h.harder@sussex.ac.uk |
Study information
| Study design | Multicenter observational mixed method study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | https://shore-c.sussex.ac.uk/docs/PEATYpisV2.pdf |
| Scientific title | Perceptions and experiences of abemaciclib and endocrine therapy |
| Study acronym | PEATY |
| Study objectives | The PEATY study aims to examine patients’ perceptions, attitudes, health beliefs, and experiences with abemaciclib and standard adjuvant endocrine therapy for ER+ HER2- breast cancer. The data collected in this study will provide a more comprehensive picture and important insights into the benefits, barriers and challenges associated with treatment in this high-risk population and its impact on their day-to-day life. This is important as patient-reported outcomes recorded in clinical trials reflect patient experiences while on treatment, but are limited by the content of the questionnaires used to assess outcomes. PEATY will employ mixed methods using semi-structured, in-depth interviews that focus on patients’ experiences and changes over time. |
| Ethics approval(s) | Approved 29/07/2021, London - Chelsea Research Ethics Committee (REC London Centre, 2 Redman Place, Stratford, London, E20 1JQ, UK; .+44 (0)207 104 8029; chelsea.rec@hra.nhs.uk), REC ref: 21/PR/0853 |
| Health condition(s) or problem(s) studied | Quality of life of women receiving abemaciclib and endocrine therapy for breast cancer |
| Intervention | Study data will be collected through three semi-structured interviews: at baseline before start of treatment, and 4 and 8 weeks later. The baseline interviews will explore patients’ understanding of the drugs prescribed, expectations of treatment, and health beliefs. The follow-up interviews will capture patients’ treatment experiences, in particular treatment side effects such as diarrhoea, how these impact day-to-day life, and how they are managed. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Abemaciclib |
| Primary outcome measure | Patients’ expectations and experiences of treatment with abemaciclib and standard adjuvant endocrine therapy for early-stage high-risk breast cancer, assessed using semi-structured interviews at baseline before the start of treatment and 4 and 8 weeks later |
| Secondary outcome measures | Patients’ information and communication needs, assessed using semi-structured interviews at baseline before the start of treatment and 4 and 8 weeks later |
| Overall study start date | 29/07/2021 |
| Completion date | 31/08/2023 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30 |
| Total final enrolment | 5 |
| Key inclusion criteria | 1. Diagnosis of ER+, HER2- breast cancer 2. Postmenopausal 3. Participating in the POETIC-A trial and randomised to receive abemaciclib and standard adjuvant endocrine therapy 4. Aged 18 years or over 5. Good comprehension of the English language |
| Key exclusion criteria | 1. Inability to understand and speak English 2. Inability to give fully informed consent |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Bournemouth
BH7 7DW
United Kingdom
Poole
BH15 2JB
United Kingdom
Redhill
RH1 5RH
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Lakin Road
Warwick
CV34 5BW
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Sponsor information
University/education
Research & Enterprise Services
Falmer House
Brighton
BN1 9QF
England
United Kingdom
| Phone | +44 (0)1273 872748 |
|---|---|
| researchsponsorship@sussex.ac.uk | |
| Website | http://www.sussex.ac.uk/ |
"ROR" |
https://ror.org/00ayhx656 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 14/12/2023: The researchers are trying the publish the results as a short communication in a peer-reviewed journal and are also submitting a conference abstract. Previous publication and dissemination plan as of 14/08/2023: The trial did not recruit sufficient patients and results will not be published in peer-reviewed journal. Previous publication and dissemination plan: The researchers plan to publish the findings from this research in a high-impact peer-reviewed journal. A plain language summary of the findings will be sent to all study participants and published on the study website. Additional documents are currently not available. |
| IPD sharing plan | Trial closed prematurely (under recruiting) data will not be published and for that reason not be shared |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
14/12/2023: Trial closed prematurely (under recruiting), publication and dissemination plan updated, intention to publish date changed from 01/12/2023 to 31/08/2024.
14/08/2023: The following changes were made to the trial record:
1. The study type 'Treatment' was added.
2. The total final enrolment was added.
3. The study participating centre The Royal Marsden Hospital was removed and University Hospitals Dorset – Royal Bournemouth Hospital, University Hospitals Dorset - Poole Hospital, Surrey and Sussex Healthcare NHS Trust - East Surrey Hospital, Shrewsbury and Telford NHS Hospital Trust - Royal Shrewsbury Hospital, South Warwickshire University NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust, The Christie NHS Foundation Trust were added.
4. The publication and dissemination plan was changed.
5. The participant level data sharing statement was changed.
15/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 01/06/2023.
2. The overall trial end date has been changed from 30/09/2022 to 31/08/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/12/2022 to 01/12/2023.
05/10/2021: Trial's existence confirmed by the Health Research Authority.
