C43.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Stage I and II melanoma patients with histologically confirmed, cutaneous primary malignant melanoma, i.e. no metastases or lymph node manifestation, no adjuvant interferon or other therapy. Patients with new disease (after surgery) and patients after surgery in the 1st + 2nd year of follow-up examinations. Prerequisites are the ability to fill out a German questionnaire and the willingness to undergo a questionnaire survey. Age between 18 and 75 years
Exclusion criteria
Exclusion criteria: Mucosal melanomas and ocular melanomas, the presence of satellite, lymph node or distant metastases (clinically or apparative diagnosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient data relevant to care is recorded using standardized questionnaires (DLQI/Dermatology Life Quality Index, EQ5D-5L/five-level version of the EuroQol five-dimensional questionnaire and HADS/Hospital Anxiety and Depression Scale) and a patient diary. Patients are interviewed twice: at the beginning of the study and after 3 months as part of aftercare, in accordance with the guidelines of the German Dermatological Society. Primary endpoint: Is there any evidence of a change in quality of life compared to the two groups (study arms). | — |
Secondary
| Measure | Time frame |
|---|---|
| Are there any indications of a change in the quality of life in the before/after comparison? | — |
Countries
Germany
Contacts
Universitätsklinikum Regensburg Klinik & Poliklinik für Dermatologie