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

University Hospital Freiburg

Status: Unknown

Conditions: Malignant Melanoma

Treatments: Behavioral: psycho-oncological intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00963261

PO5098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

psycho-oncological intervention

Experimental group

Description:

stepped care psycho-oncological intervention

Treatment:

Behavioral: psycho-oncological intervention

control group

No Intervention group