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

NCT ID: NCT00963261

Last Updated: 2010-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

psycho-oncological intervention

stepped care psycho-oncological intervention

Group Type: EXPERIMENTAL

psycho-oncological intervention

Intervention Type: BEHAVIORAL

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

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psycho-oncological intervention

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essex Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

University Medical Center Freiburg

Principal Investigators

Katrin Reuter, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

Dorothee Nashan, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, Department of Dermatology

Locations

University Medical Center Collogne, Department of Dermatology

Cologne, , Germany

Site Status: RECRUITING

University Medical Center Freiburg, Department of Dermatology

Freiburg im Breisgau, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Katrin Reuter, PhD

Role: CONTACT

katrin.reuter@uniklinik-freiburg.de

+497612706986

Karoline Albrecht, dipl. psych.

Role: CONTACT

karoline.albrecht@uniklinik-freiburg.de

+497612706990

Facility Contacts

Cornelia Mauch, MD

Role: primary

Dorothee Nashan, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25304729 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24136099 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23288588 (View on PubMed)

Other Identifiers

PO5098

Identifier Type: -

Identifier Source: org_study_id