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Improving outcomeS for Women diagnosed with early breast cancer through adhErence to adjuvant Endocrine Therapy (SWEET): study protocol for a pragmatic randomised control trial of a patient-centred intervention to improve adherence to endocrine therapy in early breast cancer

Lucy McGeagh,Alice Walker,Louise Hiller,Janet Dunn,Mary Wells,Peter Donnelly,Andrew Wardley,Jane Wolstenholme,Robert Horne,Sarah-Jane Stewart,J. Brett,C. Cahir,Deborah Fenlon,Jan Rose,Lesley Turner,Lyndsay Hughes,A. Todd,Brian Nicholson,Phil Mawson,Ruth P Norris,Sue Thompson,Helen Dakin,Raegan Barrows,Sally Kum,Mark Turner,Farah Rehman,Henry Cain,Eila K Watson,Linda Sharp,A. King,Victoria Harmer,Nicky Levitt,Anna Mann,Colin McCowan,Zoe Moon,Mia Porteous,Samuel G. Smith

Published 2025 in Trials

ABSTRACT

At least 5 years of adjuvant endocrine therapy substantially reduces risks of recurrence and mortality in oestrogen-receptor positive early breast cancer. However, adherence to endocrine therapy is sub-optimal; poor adherence is associated with higher risks of recurrence and death from breast cancer, worse cancer-specific health-related quality-of-life, and increased healthcare costs. The SWEET randomised control trial aims to evaluate effectiveness and cost-effectiveness of the HT&Me intervention in reducing poor adherence to adjuvant endocrine therapy and improve cancer-specific health-related quality-of-life in women with oestrogen-receptor positive early breast cancer. This is a UK based, pragmatic, open label randomised control trial. Participants (stages 1–3 oestrogen-receptor positive breast cancer, completed surgery, within 14 weeks of first endocrine therapy prescription; n = 1460) complete a baseline questionnaire, and are randomised to the HT&Me intervention plus usual care, or usual care alone. The HT&Me intervention is evidence-based, theory-informed and patient-centred. It consists of viewing an animation, two consultations with a SWEET study practitioner (a health care professional trained in delivering the intervention) approximately 3 months apart, access to the interactive HT&Me web-app for the 18 months, and regular monthly nudges. All participants complete follow-up questionnaires at 6, 12, and 18 months. A multi-method process evaluation will be conducted involving quantitative analysis exploring mechanisms of action of the intervention, and qualitative interviews with a sample of participants and health care professionals involved in the trial. Primary endpoints are adjuvant endocrine therapy adherence (combined self-report (Medication Adherence Report Scale) and Proportion of Days Covered calculated from prescription encashment records) and cancer-specific health-related quality-of-life (Functional Assessment of Cancer Therapy Scale- General). Secondary endpoints are adjuvant endocrine therapy-specific health-related quality-of-life and within-trial cost-utility analysis which will evaluate cost-effectiveness. The SWEET trial seeks to address a significant issue affecting the growing population of breast cancer survivors: poor adherence to adjuvant endocrine therapy. Challenges addressed and resolved within the protocol include the following: capacity at sites to deliver the intervention; variations in breast cancer services nationally; and measuring adherence. This trial has potential to improve quality of life and adherence to endocrine therapy; reducing numbers of recurrences and breast cancer deaths, benefiting women, their families and the health service. ISRCTN Number: ISRCTN24852890 registered on 02.08.2023.

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