Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence: The ROSETA Optimisation Trial

niversity of Leeds0 sites512 target enrollmentFebruary 2, 2024

Overview

Phase: 未知
Intervention: Not specified
Conditions: Supporting adjuvant endocrine therapy (AET) adherence in breast cancer
Sponsor: niversity of Leeds
Enrollment: 512
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 2, 2024

End Date

November 30, 2026

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

niversity of Leeds

•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\*

•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.