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

Plain English Summary

Background and study aims
In this study, researchers will look at quality of life in women who are receiving abemaciclib (Verzenio®) treatment for breast cancer. They will do this in two ways: a quality of life questionnaire study and an interview study. Starting a new treatment can impact on quality of life in a number of ways. Usually, studies look at this as part of a clinical trial. Although important, research has shown that the participants in clinical trials are not always comparable to the people who might be 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. This study aims to look at the impact that abemaciclib might have for women outside of a clinical trial, and how treatment might affect their quality of life and ability to maintain or return to their normal activities, roles and responsibilities.

Who can participate?
Women aged over 18 with locally advanced or metastatic breast cancer (cancer that has spread) who are about to begin treatment with abemaciclib

What does the study involve?
The researchers will ask participants to complete questionnaires measuring their general health-related quality of life, as well as endocrine symptoms (e.g. hot flushes) and side effects associated with abemaciclib such as diarrhoea. Participants will also be given a questionnaire measuring their ability to maintain or return to their normal roles and responsibilities. This includes things like caring for family members, returning to work and managing financial responsibilities. The researchers will ask them to complete these measures before starting treatment and after 1, 3 and 6 months. This will enable them to track any changes in their quality of life over time. Research suggests that diarrhoea may be a common side-effect of abemaciclib, so the researchers will ask patients to keep a weekly diarrhoea diary. This will help them to track whether or not they have experienced diarrhoea during the study, what steps (dietary or anti-diarrhoeal drugs) they may have taken to reduce it, and importantly, whether this side-effect reduces with increased time on treatment. In addition, they will ask some of the participants to take part in a qualitative interview study. These interviews will enable the researchers to explore in more depth peoples’ experiences of treatment and side effects and the impact, both positive and negative, on different areas of their lives. They want to learn how they and their healthcare professionals have tried to manage any problems, and if these successfully enabled them to fulfil their everyday roles and responsibilities.

What are the possible benefits and risks of participating?
There are no direct benefits of taking part in this study. Participating in this study will contribute to research that might benefit others in the future by helping researchers to better understand if treatment with abemaciclib impacts on aspects of quality of life. There are no risks of participating in this study. The main disadvantage is the time taken to complete questionnaires.

Where is the study run from?
Brighton and Sussex Medical School (UK)

When is the study starting and how long is it expected to run for?
April 2019 to December 2021

Who is funding the study?
Eli Lilly and Company Limited (USA)

Who is the main contact?
Dr Valerie Shilling
v.m.shilling@sussex.ac.uk

Plain English summary under review with external organisation

Trial website

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

Contact information

Type

Public

Primary contact

Dr Valerie Shilling

ORCID ID

http://orcid.org/0000-0002-5610-0321

Contact details

SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
+44 (0)1273 879734
v.m.shilling@sussex.ac.uk

Type

Scientific

Additional contact

Dr Valerie Shilling

ORCID ID

http://orcid.org/0000-0002-5610-0321

Contact details

SHORE-C
Brighton and Sussex Medical School
University of Sussex
Science Park Road
Falmer
Brighton
BN1 9RX
United Kingdom
+44 (0)1273 877934
v.m.shilling@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

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

Funding Body Type

private sector 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

16/06/2020: Trial's existence confirmed by Health Research Authority and Health and Care Research Wales (HCRW).