HR+/HER2- Early Breast Cancer
Conditions
Brief summary
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
BEHAVIORALStandardized patient coaching
Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)
Sponsors
Institut fuer Frauengesundheit
Lilly Deutschland GmbH Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to discontinuation | From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first | Time to permanent discontinuation of abemaciclib therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence rate | At 6 and 12 months after therapy start | Abemaciclib persistence rate (defined as ongoing abemaciclib therapy) |
| Satisfaction with Information about Medicines Scale (SIMS-D) | At 6 and 12 months after therapy start | 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) | At 6 and 12 months after therapy start | A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence. |
| Bloem's patient typology questionnaire | At 6 and 12 months after therapy start | 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. |
Countries
Germany
Contacts
CONTACTSponsor's study office
STUDY_CHAIRPeter A. Fasching, Prof. Dr. med.
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
Outcome results
None listed