Trial document





This trial has been registered retrospectively.
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  DRKS00003718

Trial Description

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Title

Assessment of the application of complimentary substances and methods in skin cancer patients

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Register project, which investigates the effectiveness of modern melanoma therapies in everyday conditions, the patient benefit and safety

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Brief Summary in Scientific Language

The project shoud provide reliable statements about the effectiveness of the applied treatments, the patient benefit and tolerability.

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Organizational Data

  •   DRKS00003718
  •   2013/05/15
  •   [---]*
  •   yes
  •   Approved
  •   837.157.11(7699), Landesärztekammer Rheinland-Pfalz, Mainz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   scin cancer
  •   C43-C44 -  Melanoma and other malignant neoplasms of skin
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Interventions/Observational Groups

  •   Questionnaire study: Patients are asked about the efficacy and safety of modern melanoma therapies under everyday conditions
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

For each patient using a standardized questionnaire, the use of complementary and alternative therapies (CAM) is applicable. Patients when entering the skin cancer center will be asked regarding their treatment and aftercare at defined time points (1. admission to the skin cancer center, 2.: during treatment (number of surveys available, survey each in therapy change), 3. Aftercare () several surveys possible elevation at each follow-up visit. Data will be collected on larger collectives of different skin tumor entities on user behavior of patients from skin cancer centers in different provinces levied.

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Secondary Outcome

The data on user behavior will be correlated to data for the individual patient's situation, history and treatment.
1. Motivation for the use of KAM
2. Influence of certain situations on the decision of therapy for patients KAM
3.
Patient´s assessment regarding treatment efficacy
4.
Extent of the potential interactions with anti-tumor therapy
5.
Influence of the use of CAM in the course of therapy
6.
Supportive effect of KAM
7.
Negative effects of KAM on progression-free survival and overall survival
8.
Evaluation of the questionnaire as a screening tool for the detection of user behavior regarding complementary and alternative therapies for skin cancer patients

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/09/21
  •   5000
  •   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

All patients with skin cancer who are advised and treated at a skin cancer center
- A signed consent form
- Age> 18 years

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Exclusion Criteria

- Linguistic or other restrictions that prevent the independent completion of the questionnaire
- Lack of informed consent

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Addresses

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    • ADO Tübingen / (PRIO) der Deutschen Krebsgesellschaft (DKG)
    • Liebmeierstr. 25
    • 72076  Tübingen
    • Germany
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    •   [---]*
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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr.  Carmen  Loquai 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Hautklinik und Poliklinik Universitätsmedizin Mainz der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr.  Carmen  Loquai 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Hautklinik
    • Mr.  Dr.  Frank  Meiß 
    • Hauptstr. 7
    • 79104  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/31
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Trial Publications, Results and other Documents

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