Supporting women with adherence to hormone therapy following breast cancer

Conditions

Breast cancer Cancer

McGeagh L, Walker A, Hiller L, Dunn J, Wells M, Donnelly P, Wardley A, Wolstenholme J, Horne R, Stewart SJ, Brett J, Cahir C, Fenlon D, Rose J, Turner L, Hughes L, Todd A, Nicholson B, Mawson P, Norris R, Thompson S, Dakin H, Barrows R, Kum S, Turner M, Rehman F, Cain H, Watson E, Sharp L, SWEET Research Team.

2025-11-26

10.1186/s13063-025-09056-6

Supporting women with adherence to adjuvant endocrine therapy (SWEET): feasibility study of the HT&Me intervention.

McGeagh L, Stewart SJ, Norris R, Wells M, Thompson S, Mawson P, Brett J, Turner M, Wolstenholme J, Dakin H, Donnelly P, Cain H, Rehman F, Kum S, Horne R, Taylor G, Turner L, Rose J, Sharp L, Watson E, SWEET Research Team.

2025-11-011 citations

10.1016/j.ejon.2025.103026

Interventions

SWEET is a multi-centre, unblinded, pragmatic randomised controlled trial (RCT) of HT&Me intervention + usual care vs usual care alone. The aim is to determine the clinical effectiveness of the trial

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 2. AET-specific HRQoL using Breast Cancer Trialist Prevention Checklist (BCPT; Timepoint(s): Baseline, 6 months, 12 months and 18 months 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 4. Extent of adherence using MPR (continuous); encashment records and/or GP prescribing records throughout the study 5. Suboptimal implementation self-reported using MARS-5; Timepoint(s): Baseline, 6 months, 12 months and 18 months 6. Non-persistence, self-reported using >180 days gap in AET prescriptions; Timepoint(s): Baseline, 6 months, 12 months and 18 months	—

Measure

Time frame

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 2. AET-specific HRQoL using Breast Cancer Trialist Prevention Checklist (BCPT; Timepoint(s): Baseline, 6 months, 12 months and 18 months 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 4. Extent of adherence using MPR (continuous); encashment records and/or GP prescribing records throughout the study 5. Suboptimal implementation self-reported using MARS-5; Timepoint(s): Baseline, 6 months, 12 months and 18 months 6. Non-persistence, self-reported using >180 days gap in AET prescriptions; Timepoint(s): Baseline, 6 months, 12 months and 18 months

—

Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed