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| Name | Class |
|---|---|
| Lilly Deutschland GmbH Germany | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized patient coaching | Experimental | Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized patient coaching | Behavioral | Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinuation | Time to permanent discontinuation of abemaciclib therapy | From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence rate | Abemaciclib persistence rate (defined as ongoing abemaciclib therapy) | At 6 and 12 months after therapy start |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sponsor's study office | Contact | +49 15739466438 | studien@ifg-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter A. Fasching, Prof. Dr. med. | Department of Obstetrics and Gynaecology, Uniklinikum Erlangen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynaecology | Erlangen | Bavaria | 91054 | Germany |
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| At 6 and 12 months after therapy start |
| Medication Adherence Rate Scale (MARS-D) | A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence. | At 6 and 12 months after therapy start |
| 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. | At 6 and 12 months after therapy start |