Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003617

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00003617
  •   2012/04/16
  •   2009/08/20
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00963261  (ClinicalTrials.gov)
  •   PO5098  (University Hospital Freiburg)
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Health Condition or Problem studied

  •   Malignant Melanoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Behavioral: psycho-oncological intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Changes in quality of life; time frame: 1 year

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Secondary Outcome

- Changes in fatigue; time frame: 1 year
- Changes in psychological distress; time frame: 1 year
- Changes in depressive syndrome; time frame: 1 year

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2009/04/30
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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Addresses

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    • Universitätsklinikum Freiburg - Department of Psychiatry and Psychotherapy
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
    • Katrin Reuter, PhD 
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    •   [---]*
    •   [---]*
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    • Katrin Reuter, PhD 
    end of 1:1-Block address public-contact
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.