Malignant Melanoma Clinical Trial
Official title:
Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
The purpose of this study is to analyse the physical and psychological side-effects in the course of treatment with IFN-alpha. The effectiveness of a specific intervention for the management of these side-effects is evaluated.
Today, the consideration of the side effects of intensive treatment measures and their
influence on quality of life are regarded as standard procedures in oncology. Quality of
life measurements have found their way into clinical studies as patient-reported outcomes.
In comparison to other tumor types, the field of dermato-oncology has had less research
activity concerning quality of life. However, in recent years more attention has been paid
to health related quality of life in malignant melanoma patients, especially under adjuvant
treatment with interferon-alpha. Data about high dose IFN-α treatment, especially from the
USA, show that there are significant physical and psychological side effects, such as
fatigue and depression, which often lead to dosage reduction or termination of treatment. As
yet, there are very few systematic studies about low dose IFN-α treatment, especially in
regard to the side effects during the course of the disease.
Concerning treatment side-effects it is known throughout various areas of oncology that
specific psycho-oncological interventions assist in the patients' adaptation to the illness
and handling of the side effects of therapy.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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