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Background 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. Methods 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. Discussion 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. Trial registration ISRCTN Number: ISRCTN24852890 registered on 02.08.2023.

IntroductionRecurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective.Methods and analysisRecurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation.The trial’s target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site.The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement.Ethics and disseminationThe trial was approved by the East Midlands—Nottingham 2 Research Ethics Committee on 30 March 2023.Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels.Trial registration numberISRCTN17972668.