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What is the ROSETA Optimisation trial?

Some patients with breast cancer struggle to take their medications regularly and may even stop altogether. The ROSETA Optimisation trial is testing how well four ways (called interventions) support women with breast cancer in taking hormone therapy (e.g., Tamoxifen, Raloxifene, Anastrozole, Letrozole, Exemestane). We are testing what, if any, is the best combination of the interventions.

What interventions are you testing?

SMS text reminders to support taking medication.
A leaflet providing information about the medication.
A website to provide useful resources for managing side effects of the medication.
A skills programme known as Acceptance and Commitment Therapy (ACT) which encourages approaching experiences with openness and awareness, and to support you to engage with your values. This is led by a therapist and involves learning and practising skills at home.

Who can take part?

We hope that around 500 women aged 18 and over will take part, who have been diagnosed with breast cancer and prescribed medication to reduce the risk of the cancer returning. They must have access to a mobile phone and a computer or smart device that can access the internet. Taking part is completely voluntary.

Who is organising the trial?

The trial is being run by the University of Leeds. The Chief Investigator is Professor Sam Smith, a researcher interested in the factors affecting the use of cancer medicines.

What is involved?

We will:

  • Confirm your eligibility and ask if you consent to take part.
  • Ask you to complete a total of 4 questionnaires over a period of 12 months.
  • Ask you if you are willing to be interviewed after around 4 and 12 months, to discuss your experiences of taking part. The interviews are optional, so you can take part in ROSETA without being interviewed.

You will be randomly allocated either to one or more of the interventions in addition to your usual care, or to your usual care alone. If you are randomly allocated to the ACT sessions, you will attend a total of 5 remote sessions and will be asked to complete home practice tasks.

Will I get the results?

You can choose to receive a copy of the results by email at the end of the trial.

Are you interested in taking part?

Go to the ‘Screening Questionnaire’ page to complete a screening questionnaire to see if you could be suitable to take part. You may only take part if your local hospital is taking part in the ROSETA study. Please check the ‘News’ page for a list of hospitals taking part in ROSETA. This will be updated throughout the study, so please check back regularly.