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临床试验/NCT00963261
NCT00963261Unknown不适用

Side-effect Management for Patients With Malignant Melanoma Undergoing Treatment With Interferon Alpha (IFN-α)- Diagnosis and Therapy -

University Hospital Freiburg4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
4
主要终点
Changes in quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Changes in quality of life

时间窗: 1 year

次要结局

  • Changes in fatigue(1 year)
  • Changes in psychological distress(1 year)
  • Changes in depressive syndrome(1 year)

研究者

发起方
University Hospital Freiburg
申办方类型
Other

研究点 (4)

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