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| Name | Class |
|---|---|
| Essex Pharma GmbH | INDUSTRY |
| Universitätsklinikum Köln | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| psycho-oncological intervention | Experimental | stepped care psycho-oncological intervention |
|
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psycho-oncological intervention | Behavioral | stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fatigue | 1 year | |
| Changes in psychological distress | 1 year | |
| Changes in depressive syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrin Reuter, PhD | Contact | +497612706986 | katrin.reuter@uniklinik-freiburg.de | |
| Karoline Albrecht, dipl. psych. | Contact | +497612706990 | karoline.albrecht@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Katrin Reuter, PhD | University Medical Center Freiburg, Department of Psychiatry and Psychotherapy | Principal Investigator |
| Dorothee Nashan, MD | University Medical Center, Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Collogne, Department of Dermatology | Recruiting | Cologne | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304729 | Derived | 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. | |
| 24136099 | Derived | 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D003863 | Depression |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 1 year |
| University Medical Center Freiburg, Department of Dermatology | Recruiting | Freiburg im Breisgau | 79104 | Germany |
|
| 23288588 | Derived | 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. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |