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

Not Applicable

• Conditions: Malignant Melanoma
• Interventions: Behavioral: psycho-oncological intervention

• Registration Number: NCT00963261
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-25
• Primary Completion: 2011-02
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
psycho-oncological intervention	psycho-oncological intervention	stepped care psycho-oncological intervention

Primary Outcome Measures

Name	Time	Method
Changes in quality of life	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in fatigue	1 year
Changes in psychological distress	1 year
Changes in depressive syndrome	1 year

Trial Locations

Locations (2)

University Medical Center Freiburg, Department of Dermatology; 🇩🇪 Freiburg, Germany

University Medical Center Collogne, Department of Dermatology; 🇩🇪 Köln, Germany