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

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 side-effects is evaluated.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Behavioral: psycho-oncological intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
Study Start Date : April 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: psycho-oncological intervention
stepped care psycho-oncological intervention
Behavioral: psycho-oncological intervention
stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)

No Intervention: control group

Primary Outcome Measures :
  1. Changes in quality of life [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes in fatigue [ Time Frame: 1 year ]
  2. Changes in psychological distress [ Time Frame: 1 year ]
  3. Changes in depressive syndrome [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963261

Contact: Katrin Reuter, PhD +497612706986
Contact: Karoline Albrecht, dipl. psych. +497612706990

University Medical Center Freiburg, Department of Dermatology Recruiting
Freiburg, Germany, 79104
Contact: Dorothee Nashan, MD         
Principal Investigator: Katrin Reuter, PhD         
University Medical Center Collogne, Department of Dermatology Recruiting
Köln, Germany, 50937
Contact: Cornelia Mauch, MD         
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Katrin Reuter, PhD; Dorothee Nashan, MD, University Medical Center Freiburg Identifier: NCT00963261     History of Changes
Other Study ID Numbers: PO5098
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: June 2010

Keywords provided by University Hospital Freiburg:
quality of life
psychological distress
depressive symptoms
side effects

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents