Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
This is a randomised trial using quantitative methods. Participants will complete questionnaires and take part in a verbal knowledge assessment with a researcher in relation to GEP testing.
Patient o
Sponsors
University of Sussex
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. First presentation of early stage breast cancer with all known disease surgically removed 2. Oestrogen Receptor (ER+ve) and HER-2 negative (female patients only) 3. No clear decision as to whether chemotherapy should be given as adjunct based on current prognostic criteria 4. Consented to GEP tests 5. Able to give full informed consent to IMPARTER:4 6. Good comprehension of the English language 7. Access to internet connection and compatible devices
Exclusion criteria
Exclusion criteria: 1. Other breast cancer diagnosis e.g. DCIS, metastatic 2. Unable to give fully informed consent 3. Under 18 years of age 4. Unable to understand and speak English 5. No access to internet connection and/or compatible devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients’ knowledge and understanding about GEP tests and risk of recurrence results measured by a knowledge interview prior to a patient receiving their GEP test results | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The impact of anxiety, intolerance of uncertainty and decisional conflict on decision-making (patient) assessed by the state (baseline and T2) and trait STAI measures (baseline), intolerance of uncertainty (T1) and decisional conflict measure (T2) 2. The confidence/satisfaction with GEP test result consultations (clinician) completed following the test result consultation 3. The agreement between clinician and patient on their treatment decision and whether this is influenced by the clinician’s satisfaction with interview about recurrence risk and IoU scores (clinician completes once per study prior to seeing patients), the patient’s recurrence risk, or pre-existing characteristics (trait anxiety, uncertainty) and whether GEP knowledge/understanding mitigate these | — |
Countries
England, United Kingdom
Outcome results
None listed