The ROSETA Optimisation Trial
Research type
Research Study
Full title
Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence:The ROSETA Optimisation Trial
IRAS ID
328413
Contact name
Samuel Smith
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Breast cancer is the most commonly diagnosed cancer in women. Hormone therapies have improved outcomes for women with breast cancer, however, studies suggest that between 31-73% of women with breast cancer take their hormone therapy as prescribed. The ROSETA Optimisation trial is testing how well four ways (called interventions) support women with breast cancer in taking hormone therapy. We are testing what, if any, is the best combination of the interventions.
Each intervention targets a different barrier to medication taking: SMS text reminders target memory problems, an information leaflet targets medication beliefs, a website targets managing medication side-effects, and Acceptance and Commitment Therapy (ACT) targets psychological distress. Women will be randomised to a group that includes a combination of interventions, one intervention, or no interventions. All women will receive the usual care provided by their hospital.
We aim to include 512 women with breast cancer across 25 NHS sites. Eligible women who have completed their hospital-based treatment will be approached about the study during hospital appointments or remotely. Women may also self-refer by completing an online screening questionnaire managed by the trial team at the Leeds Clinical Trials Research Unit at the University of Leeds (CTRU). The CTRU will contact patients who self-refer to inform them whether or not they may be suitable to take part, and securely pass on the details of those suitable to the research team at their local NHS site.
All women will be asked to complete study questionnaires at 4, 8 and 12 months. We will interview willing participants and ACT therapists to discuss their experiences of the interventions.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0250
Date of REC Opinion
8 Jan 2024
REC opinion
Further Information Favourable Opinion