Supporting Women with adhErence to hormonE Therapy following breast cancer (SWEET): the feasibility study
- Conditions
- Breast CancerCancer
- Registration Number
- ISRCTN29401613
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 90
Sub-study 1
The following patients will be eligible:
1. Aged 18 years old and over
2. Female
3. Diagnosis of ER-positive invasive breast cancer
4. Medium or high risk of recurrence, defined as one of the following:
4.1. T2 and N0
4.2. T2 and N>0
4.3. T1 and N>0
4.4. T1 and N0 and grade 3
5. Within 3 months of first oral adjuvant endocrine therapy (AET) prescription (tamoxifen or aromatase inhibitor)
6. Completed surgery
7. Completed chemotherapy (if applicable)
8. Can access the internet and have an email address
9. Are willing to use a support package with a web-based component
Sub-study 2
The following patients will be eligible:
1. Aged 18 years old and over
2. Female
3. Diagnosis of ER-positive invasive breast cancer
4. Medium or high risk of recurrence, defined as one of the following:
4.1. T2 and N0
4.2. T2 and N>0
4.3. T1 and N>0
4.4. T1 and N0 and grade 3
5. Were first prescribed oral AET (tamoxifen or aromatase inhibitor) within the past 9-36 months
6. Have completed surgery
7. Have completed chemotherapy (if applicable)
Sub-study 1 and 2 exclusion criteria:
The following patients with early-stage ER+ve invasive breast cancer will be ineligible:
1. Male
2. Have been prescribed adjuvant CDK4/6i (abemaciclib)
3. Have cognitive impairment sufficient to preclude participation, as judged by the clinical team
4. Are unable to read and understand English
5. Had previous AET (for another breast cancer)
6. Have not had surgery for breast cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method