NCT00963261

Quality of Life and Psychological Well-being in Patients With Malignant Melanoma

Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BEHAVIORAL	psycho-oncological intervention	stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-02-01
• Completion: 2012-04-01
• First posted: 2009-08-21
• Last updated: 2010-06-25

Locations

2 sites across 1 country: Germany