Quality of life of women receiving abemaciclib for breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
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 par
Sponsors
University of Sussex
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactHelena Harder
Outcome results
None listed