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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Sam
Smith
+44 (0)113 343 0892
S.Smith1@leeds.ac.uk
Dr
ROSETA Optimisation
Trial Team
None provided
ROSETA@leeds.ac.uk
Supporting adjuvant endocrine therapy (AET) adherence in breast cancer
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
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). The study will test what, if any, is the best combination of the interventions. The interventions being tested comprise SMS text reminders to support taking medication, a leaflet providing information about the medication, a website to provide useful resources for managing the side effects of the medication, and a skills programme known as Acceptance and Commitment Therapy (ACT) which encourages approaching experiences with openness and awareness, and supports you to engage with your values. This is led by a therapist and involves learning and practising skills at home.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Stopped taking AET if it is clinically contraindicated according to clinical recommendation 2. Involved in a similar research trial where medication adherence is a primary outcome*,** 3. Currently attending psychotherapy/psycho-oncology/psychology/counselling services, for any clinical reason* 4. Need for treatment for a severe mental health disorder or crisis, which is likely to interfere with participation (e.g., active psychosis, bipolar disorder, significant issues with addiction or self-harm or expressing active suicidal ideation with active plans and intent*)5. Auditory problems that would prevent the patient from participating in a telephone or video call, or hearing audio clips*6. Taken part in the ROSETA Pilot trial.
*Source data for these items will be either partially or completely patient self-report.**Consented to and the trial is still being delivered.
Participation in another trial will not necessarily exclude a patient from participation. CTRU should be notified of any potential conflicting trials to facilitate a review of the feasibility of co-enrolment by the CI and Trial Management Group (TMG). The review will consider the methodological impact and participant burden.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
ROSETA Optimisation
Trial Team
None provided
ROSETA@leeds.ac.uk
Prof
Sam
Smith
+44 (0)113 343 0892
S.Smith1@leeds.ac.uk
The study is sponsored by University of Leeds and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58021
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
