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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520290-12-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Typology-based coaching | Experimental | Personalized therapy coaching based on patient typology |
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| Standard of care patient counselling | No Intervention | Standard of care therapy education and counselling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Typology-based coaching | Behavioral | Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT) |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinuation | Time to permanent discontinuation of ribociclib therapy | From baseline up to end of study (max. 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Ribociclib persistence rate | Ribociclib persistence rate (defined as ongoing ribociclib therapy) | At 6, 12 and 36 months after therapy start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Institut für Frauengesundheit GmbH | Contact | +49 9131 91880613 | typer@ifg-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Manfred Welslau, Dr. med. | MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie | Principal Investigator |
| Nina Ditsch, Prof. Dr. med. | Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| Department of Obstetrics and Gynecology, Uniklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie | Recruiting | Hösbach | Bavaria | 63768 | Germany |
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