Clinical trial · Interventional
IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib. The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care. Participants will be asked to answer several questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+/HER2- Early Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized patient coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standardized patient coaching
- description
- Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
- interventionNames
- Behavioral: Standardized patient coaching
Primary outcomes (1)
- measure
- Time to discontinuation
- timeFrame
- From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first
- description
- Time to permanent discontinuation of abemaciclib therapy
Secondary outcomes (4)
- measure
- Persistence rate
- timeFrame
- At 6 and 12 months after therapy start
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women age 18 or older at time of ICF signature * Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago * Patients treated with abemaciclib according to the SmPC and each center´s medical practice * Informed consent given prior to the starting study activities Exclusion Criteria: * Women who are pregnant or lactating * Patients with contraindications against abemaciclib according to the current SmPC * Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician
References
Publications (0)
Data not yet available