Refining and Optimising a behavioural intervention to Support Endocrine Therapy - The ROSETA Pilot Trial

niversity of Leeds0 sites52 target enrollmentDecember 16, 2021

Overview

2023 Other publications in https://doi.org/10.3310/nihropenres.13337.2 process evaluation protocol (added 26/10/2023)

Registry

who.int

Start Date

December 16, 2021

End Date

April 30, 2023

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

niversity of Leeds

•Current inclusion criteria as of 10/01/2023:
•1\. An informed consent form (signed and dated)
•2\. Capacity to provide informed consent
•3\. Women with early stage (1 to 3a) breast cancer according to the 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 study, providing the most recent cancer is being treated with adjuvant endocrine therapy, 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’
•4\. Aged \=18 years at time of screening for ROSETA’s pilot study
•5\. Have sufficient proficiency in English to be able to adhere to all intervention components and data collection required
•6\. Treated with curative intent
•7\. 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 study if they are being treated with monoclonal antibody\-based therapy such as trastuzumab, kadcyla, pertuzumab, and phesgo

•Current exclusion criteria as of 10/01/2023:
•1\. Stopped taking adjuvant hormone therapy if it is clinically contraindicated according to clinical recommendation
•2\. Women with metastatic breast cancer
•3\. Currently or recently (last 6 months) involved in a similar research study where medication adherence is a primary outcome\*
•4\. Currently attending psychotherapy/psycho\-oncology/psychology/counselling services, for any clinical reason\*
•5\. 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\*)
•Note, if concerned about the possible presence of risk of suicidal ideation with active plans and intent, then this can be assessed with the following questions, with patients ineligible if they answer ‘yes’ to 5\.3\.
•Recently (in the last month):
•5\.1\. Have you had any thoughts about ending your life?
•5\.2\. (if yes) Have you thought about how you might go about it?