Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Freiburg, Tyskland, 79104
- Rekruttering
- University Medical Center Freiburg, Department of Dermatology
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Kontakt:
- Dorothee Nashan, MD
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Ledende efterforsker:
- Katrin Reuter, PhD
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Köln, Tyskland, 50937
- Rekruttering
- University Medical Center Collogne, Department of Dermatology
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Kontakt:
- Cornelia Mauch, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: kontrolgruppe
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Eksperimentel: psycho-oncological intervention
stepped care psycho-oncological intervention
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stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Changes in quality of life
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in fatigue
Tidsramme: 1 year
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1 year
|
|
Changes in psychological distress
Tidsramme: 1 year
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1 year
|
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Changes in depressive syndrome
Tidsramme: 1 year
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1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Katrin Reuter, PhD, University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
- Ledende efterforsker: Dorothee Nashan, MD, University Medical Center, Department of Dermatology
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PO5098
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