Clinical trial · Interventional
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 -
NCT00963261CI-TRIAL-00003600unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psycho-oncological intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- psycho-oncological intervention
- description
- stepped care psycho-oncological intervention
- interventionNames
- Behavioral: psycho-oncological intervention
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (1)
- measure
- Changes in quality of life
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Changes in fatigue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDReuter 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. PMID 25304729
- DERIVEDAlbrecht 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. PMID 24136099
- DERIVEDAlbrecht 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. PMID 23288588