C50
Conditions
Interventions
Group 1: Performing a patient typologization and providing communication and coaching concepts adapted to the patient type by specially trained medical professionals.
To measure the primary endpoint,
Sponsors
Arbeitskreis klinische Studien e.V.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for centres 1. offer follow-up care after primary breast cancer 2. administer endocrine therapies 3. administer parenteral tumour therapies Inclusion criteria for patients 1. hormone receptor positive breast cancer 2. completed curative primary treatment 3. receiving adjuvant endocrine therapy that was started no more than 8 weeks ago
Exclusion criteria
Exclusion criteria: Exclusion criteria for institutions 1. participation in other structured follow-up programmes or studies 2. fewer than 85 patients with primary breast cancer per year Exclusion criteria for patients 1. metastasised breast cancer 2. participation in aftercare programmes (e.g. Onko-Coach) or aftercare studies (e.g. Better Care) 3. medically diagnosed severe acute depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is adherence to adjuvant endocrine therapy. A patient is considered non-adherent if he takes the therapy on less than 80 % of the days within the 12 months observed. Adherence is continuously recorded via the medication diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (PROMIS 29 Baseline & 12 month follow-up) Health literacy (As part of the process evaluation) Symptom development (EORTC QLQ-BR45, Baseline & 12 month follow-up) Treatment satisfaction (As part of the process evaluation) | — |
Countries
Germany
Contacts
Public ContactManfred Welslau
Arbeitskreis klinische Studien e.V.
Outcome results
None listed