The ROSETA Optimisation Trial – Investigating strategies to improve medication adherence in women with early-stage breast cancer

Not Applicable

• Conditions: Supporting adjuvant endocrine therapy (AET) adherence in breast cancer; Cancer

• Registration Number: ISRCTN17334319
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Last Update Posted: 24 June 2024
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 512

Inclusion Criteria

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
Note: Women being treated for a second primary breast cancer or a breast cancer local recurrence are eligible for the trial, providing at least one of the cancers is being treated with AET, and they meet all eligibility criteria. Women with bilateral breast cancer are permitted, providing at least one breast is affected by hormone receptor-positive disease
3. Aged > = 18 years old
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*

*Source data for these items will be either partially or completely patient self-report.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the most effective intervention package for supporting adjuvant endocrine therapy (AET) adherence by using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) measure – collected at 12 months post-randomisation