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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00963261
• Other study ID #: PO5098
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2009
• Last updated: June 24, 2010
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2010
• Source: University Hospital Freiburg
• Contact: Katrin Reuter, PhD
• Phone: +497612706986
• Email: katrin.reuter[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-a within a study or analog treatment schedule with IFN-a

• 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-a

• Insufficient knowledge of German language

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg, Department of Dermatology	Freiburg
Germany	University Medical Center Collogne, Department of Dermatology	Köln

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Freiburg	Essex Pharma GmbH, Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of life		1 year	No
Secondary	Changes in fatigue		1 year	No
Secondary	Changes in psychological distress		1 year	No
Secondary	Changes in depressive syndrome		1 year	No