Quality of Life and Psychological Well-being in Patients With Malignant Melanoma
Recruitment status was Recruiting
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| First Received Date ICMJE | August 20, 2009 | ||||||||
| Last Updated Date | June 24, 2010 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00963261 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Quality of Life and Psychological Well-being in Patients With Malignant Melanoma | ||||||||
| Official Title ICMJE | Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy - | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Malignant Melanoma | ||||||||
| Intervention ICMJE | Behavioral: psycho-oncological intervention
stepped care treatment program with different elements (patient information, exercise, psychoeducation, individual and group therapy, psycho-pharmacology) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Estimated Completion Date | April 2012 | ||||||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00963261 | ||||||||
| Other Study ID Numbers ICMJE | PO5098 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Katrin Reuter, PhD; Dorothee Nashan, MD, University Medical Center Freiburg | ||||||||
| Study Sponsor ICMJE | University Hospital Freiburg | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital Freiburg | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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