Status:
UNKNOWN
Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Essex Pharma GmbH
Universitätsklinikum Köln
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 f...
Eligibility Criteria
Inclusion
- Documented and proven stage Ib up to stage IIIc malignant melanoma
- No clinical and radiological evidence or suspicion of persistent disease
- Treatment with IFN-α within a study or analog treatment schedule with IFN-α
- ECOG performance status \< 2
- Constant after care
- Informed consent to participate in the study
- melanoma diagnosis within the last 5 years or therapy, recurrence or progression within this period of time.
Exclusion
- Inoperable lymph nodes- or distant metastases
- Tumors of other origins or localisations within the past 10 years
- Severe and permanent infectious diseases, e. g. HIV or hepatitis
- Participation in other treatment studies apart from IFN-α
- Insufficient knowledge of German language
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00963261
Start Date
April 1 2009
End Date
April 1 2012
Last Update
June 25 2010
Active Locations (2)
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1
University Medical Center Collogne, Department of Dermatology
Cologne, Germany, 50937
2
University Medical Center Freiburg, Department of Dermatology
Freiburg im Breisgau, Germany, 79104