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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Behavioral: psycho-oncological intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psycho-oncological intervention<br>stepped care psycho-oncological intervention | Behavioral: psycho-oncological intervention<br>* stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fatigue |  | 1 year | 
| Changes in psychological distress |  | 1 year | 
| Changes in depressive syndrome |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, interferon-a, quality of life, psychological distress, depressive symptoms, side effects