C50
Conditions
Interventions
Group 1: Introduction and assessment of a standardized consultation sessions for OTT in high-risk eBC patients within oncological practice
Sponsors
LMU Klinikum, Brustzentrum
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of high-risk eBC. Completion of locoregional therapy (surgery, radiotherapy) and eventual (neo-)-adjuvant chemotherapy according to clinical practice. Indication for extended adjuvant oral therapy with Abemaciclib, Ribociclib, Neratinib or Olaparib (according to EMA approval and local guidelines as well as physician’s choice). Both concurrent bisphosphonate treatment or endocrine therapy is allowed (including Tamoxifen or an aromatase inhibitor +/- GnRH). Ability and willing to use CANKADO app. Availability of hardware: computer and/or tablet and/or smartphone with internet access. Ability and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients < 18 years. Patients already enroled in other studies involving eHealth systems. Lack of consent to participate in the proposed oral tumor consultation session or lack of patient´s ability to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the evaluation of the role of nurse-conducted consultation sessions in high-risk early breast cancer (eBC) patients treated with adjuvant oral tumor therapy (OTT) during the first 6 months of therapy in terms of adherence to treatment, therapy safety, medical team’s (physicians, nurses, pharmacologists) workload and attitude OTT. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Implementation of an interactive autonomous eHealth system and assessment of adherence to treatment and therapy safety (measured by daily documentation of drug intake and global health status) through the use of CANKADO app. - Assessment of an efficient and effective approach of side effects and drug interactions management (via CANKADO app, specialized nurse-based consultation session and specialized pharmacological visits). - Assessment of patients’ QoL and impact of cancer and anticancer treatments in patients’ life (using QoL questionnaire, FACT B, v4.0 and EQ-5D-5L). - Evaluation of similarities and differences in OTT management in different healthcare settings comparing German and Italian obtained data. - Improvement of knowledge of OTT management in eBC patients in the oncology networks and increase of oral tumor consultation sessions in day clinics throughout Germany and in Italy (providing training materials for healthcare professionals such as congresses, webinars and workshops). | — |
Countries
Germany, Italy
Contacts
Public ContactRachel Würstlein
LMU Klinikum, Brustzentrum
Outcome results
None listed