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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963261
Recruitment Status : Unknown
Verified June 2010 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : August 21, 2009
Last Update Posted : June 25, 2010
Essex Pharma GmbH
Universitätsklinikum Köln
Information provided by:
University Hospital Freiburg

August 20, 2009
August 21, 2009
June 25, 2010
April 2009
February 2011   (Final data collection date for primary outcome measure)
Changes in quality of life [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00963261 on Archive Site
  • Changes in fatigue [ Time Frame: 1 year ]
  • Changes in psychological distress [ Time Frame: 1 year ]
  • Changes in depressive syndrome [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
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 -
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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Malignant Melanoma
Behavioral: psycho-oncological intervention
stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)
  • Experimental: psycho-oncological intervention
    stepped care psycho-oncological intervention
    Intervention: Behavioral: psycho-oncological intervention
  • No Intervention: control group

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2012
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Katrin Reuter, PhD; Dorothee Nashan, MD, University Medical Center Freiburg
University Hospital Freiburg
  • Essex Pharma GmbH
  • Universitätsklinikum Köln
Principal Investigator: Katrin Reuter, PhD University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Principal Investigator: Dorothee Nashan, MD University Medical Center, Department of Dermatology
University Hospital Freiburg
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP