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.
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
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
Single group
Standardized patient 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 abemaciclib therapy
Persistence rate
Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)
Satisfaction with Information about Medicines Scale (SIMS-D)
This scale assess the patient´s knowledge about their treatment. The total score ranges from 0 to 17, with higher scores indicating a higher degree of overall satisfaction with information received.
Medication Adherence Rate Scale (MARS-D)
A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence.
Bloem's patient typology questionnaire
This 6-item instrument classifies patients into four segments: 1) High Acceptance / High Control (Active/Adjusted): Good mental, low care need. 2) Low Acceptance / High Control (Struggling/Active): High need for support to accept the situation. 3) High Acceptance / Low Control (Resigned/Passive): High need for educational/proactive support. 4) Low Acceptance / Low Control (Vulnerable/Anxious): Highest care need, requires intense supportive care.
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Institut fuer Frauengesundheit
Lead sponsor
Lilly Deutschland GmbH Germany
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
