Supporting women with adherence to hormone therapy following breast cancer

Not Applicable

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN24852890
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-02
• Last Update Posted: 2 September 2024
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1460

Inclusion Criteria

1. Aged 18+ years
2. Female
3. Diagnosis of ER-positive invasive breast cancer, stages 1-3 and treated with curative intent
4. Completed surgery for breast cancer
5. Within 3 months of first oral AET prescription (tamoxifen or aromatase inhibitor) post breast cancer completion surgery
6. Completed chemotherapy (if applicable)
7. Able to access the internet
8. Has an email address
9. Are willing to use a support package with a web-based component

Exclusion Criteria

1. Male
2. Evidence of metastatic disease i.e. stage 4 disease (M1 regardless of T and N status)
3. Have cognitive impairment sufficient to preclude participation, as judged by the clinical team
4. Had previous AET (for another breast cancer)
5. Are unable to read and understand English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AET adherence using combined self-report (Medical Adherence Report Scale (MARS-5) and prescription encashment records (e.g. Medication Possession Ratio (MPR); Timepoint(s): Baseline, 6 months, 12 months and 18 months

Secondary Outcome Measures

Name	Time	Method
1. Cancer-specific HR-QOL using Functional Assessment of Cancer Therapy scale- General (FACT-G); Timepoint(s): Baseline, 6 months, 12 months and 18 months<br>2. AET-specific HRQoL using Breast Cancer Trialist Prevention Checklist (BCPT; Timepoint(s): Baseline, 6 months, 12 months and 18 months<br>3. Cost-effectiveness using within-trial cost per quality-adjusted life year (QALY); QALYs; resource use and cost to NHS, patients and society, and EQ-5D-5L; Timepoint(s): Baseline, 6 months, 12 months and 18 months<br>4. Extent of adherence using MPR (continuous); encashment records and/or GP prescribing records throughout the study<br>5. Suboptimal implementation self-reported using MARS-5; Timepoint(s): Baseline, 6 months, 12 months and 18 months<br>6. Non-persistence, self-reported using >180 days gap in AET prescriptions; Timepoint(s): Baseline, 6 months, 12 months and 18 months