Trial document

This trial has been registered retrospectively.
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Trial Description

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Development and piloting of a decision support tool to support decision making in the context of risk-adapted prevention for patients with pathogenic BRCA1/2 mutations

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Trial Acronym

not available

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URL of the Trial


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Brief Summary in Lay Language

Creation of a patient-oriented decision aid based on a genetic test for the probability of breast cancer.

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Brief Summary in Scientific Language

-Supporting the decision-making process and minimising decision-making conflicts within the framework of risk-adapted prevention.
-Supporting those seeking advice in actively including their preferences and values in decision-making.
-Improving knowledge and understanding of the individual risk of disease and the benefits and risks of different prevention strategies.
-Through decision-making participation, a reduction of emotional stress and personal maturation is aimed at.

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Organizational Data

  •   DRKS00015823
  •   2019/06/14
  •   [---]*
  •   yes
  •   Approved
  •   17-128, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Patients with BRCA1/2 (BReast CAncer) mutation without cancer

    (Patients receive a written decision guide; at the end of their decision-making process, patients complete a standardized questionnaire to see how helpful the written decision guide has been.)
  •   Patients with BRCA1/2 mutation with cancer
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  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Change in the severity of the decision conflict (DCS-D score difference) between the time points T1 (after genetic reporting/risk consultation at the doctor's consultation) and T2 (after decision for an alternative course of action has been made)

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Secondary Outcome

Comparison with patients from other clinics without decision aids

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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  •   Actual
  •   2018/11/15
  •   278
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. healthy women
2. women with unilateral breast cancer (first disease without metastasis)
3. sufficient decision-making ability to give informed written consent in accordance with the ICH-GCP guidelines and national/local regulations.
4. sufficient language skills to complete the questionnaires

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Exclusion Criteria

1. women with relapse or metastasis of breast cancer, ovarian cancer, or other cancer who are ill
2. women unable to give informed consent
3. women without sufficient knowledge of the German language

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  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Institut für Gesundheitsökonomie und Klinische Epidemiologie
    • Ms.  Dr.  Sibylle  Kautz-Freimuth 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    • Zentrum Familiärer Brust- und Eierstockkrebs Universitätsklinikum Köln
    • Ms.  Prof. Dr.  Rita  Schmutzler 
    • Kerperner Straße 34
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Landeszentrum Gesundheit Nordrhein-Westfalen (LZG.NRW)
    • Gesundheitscampus 10
    • 44801  Bochum
    • Germany
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  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.