Impact of abemaciclib on patients' roles and responsibilities
| ISRCTN | ISRCTN17281696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17281696 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 279088 |
| Protocol serial number | IRAS 279088 |
| Sponsor | University of Sussex |
| Funder | Eli Lilly and Company |
- Submission date
- 16/06/2020
- Registration date
- 16/06/2020
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
 ORCID ID |
0000-0002-7296-8227 |
|---|---|
| Phone | +44 (0)1273 873019 |
| impactor@sussex.ac.uk |
Scientific
SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
| ORCID ID |
0000-0002-7296-8227 |
|---|---|
| Phone | +44 (0)1273 873019 |
| impactor@sussex.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre observational quality of life study with nested qualitative interview study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Impact of abemaciclib on patients' roles and responsibilities: a multi-centre observational quality of life study with nested qualitative interview study |
| Study acronym | IMPACTOR |
| Study objectives | The principal objective of the study is to investigate breast cancer patients’ experiences of abemaciclib treatment outside of a clinical trial setting. The primary aim is to chart any changes in their quality of life in the first 6 months of treatment, and the impact of this treatment on patients’ ability to perform their normal roles and responsibilities. The researchers will conduct semi-structured interviews with a subset of the participants to achieve a more in-depth, richer understanding of their experiences of treatment, both positive and negative, side effects, and ways in which their day to day activities have been affected. One of the side effects more commonly associated with abemaciclib is diarrhoea. The researchers will ask participants to record their experiences of diarrhoea, and the measures they took to manage it, using a diarrhoea diary. This will enable them to assess whether treatment-related diarrhoea is manageable and decreases over time, as current trial data suggests. |
| Ethics approval(s) |
Approved 17/04/2020, North East Tyne and Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 972 2496; tyneandwearsouth.rec@hra.nhs.uk), ref: 20/NE/0101 |
| Health condition(s) or problem(s) studied | Quality of life of women receiving abemaciclib for breast cancer |
| Intervention | This is a quality of life observational study. Participants will complete validated quality of life measures at baseline, 1, 3 and 6 months and a weekly diarrhoea management diary. A subset of the participants will take part in a semi-structured qualitative interview study after 3 months. |
| Intervention type | Drug |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Abemaciclib |
| Primary outcome measure(s) |
1. Quality of life assessed using the Functional Assessment of Cancer Treatment general scale (FACT-G) with diarrhoea (DS) and endocrine symptom (ES) subscale at baseline, 1, 3 and 6 months |
| Key secondary outcome measure(s) |
1. Qualitative evidence of patients’ experience of treatment collected via a semi-structured interview at 3 months |
| Completion date | 08/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 150 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Patients with locally advanced or metastatic breast cancer who are prescribed either: 1.1. Abemaciclib in combination with fulvestrant (for women who have relapsed after endocrine therapy), or 1.2. Abemaciclib in combination with an aromatase inhibitor (for women who have not previously been treated) 2. Patients who are able to give fully informed consent and are able to read and speak in English 3. Patients who are 18 years old and over |
| Key exclusion criteria | 1. Patients with cancers other than breast or receiving treatments other than abemaciclib 2. Patients who are not able to provide fully informed consent or who are not able to read and speak English 3. Patients under 18 years of age 4. Patients who are currently inpatients or who are too distressed to participate |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Eastern Road
Brighton
BN2 5BE
United Kingdom
Bebington
Wirral
CH63 4JY
United Kingdom
London
SW3 6JJ
United Kingdom
Manchester
M20 4BX
United Kingdom
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Guildford
GU2 7XX
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The anonymised datasets generated during and/or analysed during the current study will be available upon (reasonable) request after publication of the findings from Sussex Health Outcomes Research and Education in Cancer (adminshore-c@sussex.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/04/2025 | 28/04/2025 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | Qualitative analysis | 26/04/2025 | 28/04/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/04/2025: Publication references and IPD sharing plan added, publication and dissemination plan updated.
20/08/2024: The intention to publish date was changed from 31/08/2024 to 01/01/2025. Total final enrolment added.
08/03/2024: The following changes were made:
1. The overall study end date was changed from 30/06/2023 to 08/03/2023.
2. The intention to publish date was changed from 30/06/2024 to 31/08/2024.
15/12/2022: The contact confirmed the record is up to date.
20/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 31/12/2022.
2. The overall end date was changed from 15/12/2022 to 30/06/2023.
3. The intention to publish date was changed from 01/08/2023 to 30/06/2024.
24/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 30/06/2022.
2. The overall trial end date has been changed from 31/03/2022 to 15/12/2022.
3. The intention to publish date has been changed from 31/12/2022 to 01/08/2023.
21/09/2021: The overall end date was changed from 31/12/2021 to 31/03/2022.
09/12/2020: The following changes were made to the trial record:
1. The trial participating centres Airedale General Hospital, Kent and Canterbury Hospital, The Royal Bournemouth Hospital, Royal Surrey NHS Foundation Trust, Lothian Health Board, Yeovil District Hospital NHS Foundation Trust were added.
2. The link in the plain English summary was corrected.
07/12/2020: The public and scientific contact has been changed.
21/10/2020: Cancer Research UK lay summary link added to plain English summary field.
16/06/2020: Trial's existence confirmed by Health Research Authority and Health and Care Research Wales (HCRW).
