The ROSETA trial

Overview

The ROSETA trial is an NIHR-funded multi-centre trial using a 2⁴ factorial experimental design to optimise a complex intervention to support adherence to adjuvant endocrine therapy in women affected by stage I to III breast cancer. 512 women will be randomised to one of 16 conditions, each of which is formed of a unique combination of four intervention components: SMS messaging, patient education, guided self-help, access to online self-management. All women will have access to standard care. The data are combined at the end of the trial to examine the best combination of components for supporting medication adherence. 

Objectives

To determine the most effective intervention package for supporting adjuvant endocrine therapy adherence at 12-months post-randomisation

Primary outcomes

• ·       Self-reported medication adherence

Secondary outcomes

• ·       Self-efficacy
• ·         Quality of life
• ·         Habits
• ·         Medication beliefs
• ·         Psychological distress
• ·         Health-related quality of life
• ·         Cost

Inclusion/ exclusion criteria

Inclusion

1.             Capacity to provide informed consent
2.       Women with early stage (1-3) breast cancer according to the Tumor, Node, Metastasis (TNM)/American Joint Committee on   Cancer (AJCC) staging system 
3.             Aged ≥18 years
4.       Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required
5.       Treated with curative intent
6.     Completed their hospital-based treatment (e.g. surgery, radiotherapy and/or chemotherapy) for the current breast cancer within the last 12 months    Note: Women are still eligible for the trial if they are being treated with abemaciclib or monoclonal antibody-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo; these medications do not have to be completed within the 12 months stipulated within this criterion.

7. Currently prescribed oral AET (tamoxifen, raloxifene, anastrozole, letrozole, exemestane) 

8.   Access to a mobile phone to receive SMS messages

9.   Access to a computer or smart device that can access the internet

Exclusion

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 otcome
3.       Currently attending psychotherapy/psycho-oncology/psychology/counselling services for any reasons
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.

Planned sample size

512 randomised participants

Total number of sites planned

25 sites target

Timeline

End of recruitment 31/03/2025 – extension planned

End of trial 30/11/2026 (all analysis and write up completed)