IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized patient coaching.
- Who it may be relevant to
- Registry conditions: HR+/HER2- Early Breast Cancer. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Behavioral Standardized patient coaching
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
Primary outcome measures
- Time to discontinuation [Time frame: From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first]
Secondary outcome measures (4)
- Persistence rate [Time frame: At 6 and 12 months after therapy start]
- Satisfaction with Information about Medicines Scale (SIMS-D) [Time frame: At 6 and 12 months after therapy start]
- Medication Adherence Rate Scale (MARS-D) [Time frame: At 6 and 12 months after therapy start]
- Bloem's patient typology questionnaire [Time frame: At 6 and 12 months after therapy start]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- Department of Obstetrics and Gynaecology — Erlangen
Identifiers
NCT: NCT07521202 · IFG-01-2025