Condition category
Cancer
Date applied
16/06/2020
Date assigned
16/06/2020
Last edited
09/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/
a-study-of-the-effect-abemaciclib-has-on-the-daily-life-of-people-who-take-it-impactor

Trial website

https://shore-c.sussex.ac.uk/impactor.html

Contact information

Type

Public

Primary contact

Dr Helena Harder

ORCID ID

http://orcid.org/0000-0002-7296-8227

Contact details

SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
+44 (0)1273 873019
impactor@sussex.ac.uk

Type

Scientific

Additional contact

Dr Helena Harder

ORCID ID

http://orcid.org/0000-0002-7296-8227

Contact details

SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
+44 (0)1273 873019
impactor@sussex.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 279088

Study information

Scientific title

Impact of abemaciclib on patients' roles and responsibilities: a multi-centre observational quality of life study with nested qualitative interview study

Acronym

IMPACTOR

Study hypothesis

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

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, UK; +44 (0)207 972 2496; tyneandwearsouth.rec@hra.nhs.uk), REC ref: 20/NE/0101

Study design

Multi-centre observational quality of life study with nested qualitative interview study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

The participant information sheet will be made available at https://shore-c.sussex.ac.uk/impactor.html

Condition

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 names

Abemaciclib

Primary outcome measure

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
2. Role function assessed using the Patient Roles and Responsibilities Scale (PRRS) at baseline, 1, 3 and 6 months

Secondary outcome measures

1. Qualitative evidence of patients’ experience of treatment collected via a semi-structured interview at 3 months
2. Treatment-related diarrhoea measured using the Diarrhoea Management Diary (DMD) completed weekly for 6 months
3. Strategies employed to counter diarrhoea, including non-adherence to treatment, measured using the DMD completed weekly for 6 months

Overall trial start date

24/04/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant 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

Recruitment start date

01/09/2020

Recruitment end date

30/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
Royal Sussex County Hospital Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

The Clatterbridge Cancer Centre NHS Foundation Trust
Clatterbridge Road Bebington
Wirral
CH63 4JY
United Kingdom

Trial participating centre

The Royal Marsden NHS Foundation Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

The Christie NHS Foundation Trust
Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

Airedale General Hospital
Airdale NHS Foundation Trust Skipton Road Steeton
Keighley
BD20 6TD
United Kingdom

Trial participating centre

Kent and Canterbury Hospital
East Kent Hospitals University NHS Foundation Trust Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Trial participating centre

The Royal Bournemouth Hospital
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Royal Surrey NHS Foundation Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

Lothian Health Board
Waverley Gate 2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom

Trial participating centre

Yeovil District Hospital NHS Foundation Trust
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Sponsor information

Organisation

University of Sussex

Sponsor details

Research and Enterprise Services
Falmer
Brighton
BN1 9QF
United Kingdom
+44 (0)1273 872748
researchsponsorship@sussex.ac.uk

Sponsor type

University/education

Website

http://www.sussex.ac.uk/

Funders

Funder type

Industry

Funder name

Eli Lilly and Company

Alternative name(s)

Lilly, Eli Lilly & Co, Eli Lilly & Company

Funding Body Type

government organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

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: https://shore-c.sussex.ac.uk/impactor.html. Additional documents are not currently available.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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).