The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib. Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.
Participant provides written informed consent prior to the beginning of trial-specific procedures.
Patients must be aged ≥18 years on the day of signing informed consent.
Participant has histologically confirmed primary invasive adenocarcinoma of the breast.
Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or progesterone receptor-positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory.
Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
Patients with serious preexisting medical condition(s) that would preclude participation in this study.
Women who are pregnant or lactating.
Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen-positive]).
Parallel
Typology-based coaching
BehavioralStandardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
Time to discontinuation
Time to permanent discontinuation of ribociclib therapy
Ribociclib persistence rate
Ribociclib persistence rate (defined as ongoing ribociclib therapy)
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