Clinical trial NCT00963261: Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Official title: Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Melanoma
Keywords: melanoma
interferon-a
quality of life
psychological distress
depressive symptoms
side effects
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Essex Pharma GmbH
name: Universitätsklinikum Köln
First posted: 2009-08-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Changes in fatigue
timeFrame: 1 year
measure: Changes in psychological distress
timeFrame: 1 year
measure: Changes in depressive syndrome
timeFrame: 1 year
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg, Department of Dermatology
city: Köln
country: Germany
facility: University Medical Center Collogne, Department of Dermatology
Study officials:
affiliation: University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
name: Katrin Reuter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center, Department of Dermatology
name: Dorothee Nashan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reuter K, Albrecht K, Seelig H, Meiss F, Mauch C, Kreuzberg N, Nashan D. Health-related quality of life, fatigue, and depression under low-dose IFN-alpha therapy in melanoma patients. J Immunother. 2014 Nov-Dec;37(9):461-7. doi: 10.1097/CJI.0000000000000057.
citation: Albrecht KJ, Nashan D, Meiss F, Bengel J, Reuter K. Shared decision making in dermato-oncology: preference for involvement of melanoma patients. Melanoma Res. 2014 Feb;24(1):68-74. doi: 10.1097/CMR.0000000000000030.
citation: Albrecht K, Droll H, Giesler JM, Nashan D, Meiss F, Reuter K. Self-efficacy for coping with cancer in melanoma patients: its association with physical fatigue and depression. Psychooncology. 2013 Sep;22(9):1972-8. doi: 10.1002/pon.3238. Epub 2013 Jan 3.