Trial document





This trial has been registered retrospectively.
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  DRKS00015823

Trial Description

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Title

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

http://none

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Brief Summary in Lay Language

1. preparation of a decision aid in two modifications for women with pathogenic BRCA1/2 mutation without cancer (modification A) or with unilateral breast cancer (modification B), who are faced with the question of which preventive measure they would like to choose at what time to counter their increased risk of breast cancer and/or ovarian cancer.
2. pilot testing of decision support tools in clinical use and evaluation in a randomized controlled clinical trial.

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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.
-By participating in decision-making, the aim is to reach an informed decision in accordance with one's own preferences and values, which leads to greater satisfaction with the decision made.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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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
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   IG (A): Seekers with pathogenic BRCA1/2 mutation without cancer.
    Those seeking advice receive a written decision support in paper format immediately after their genetic test results or in the further course of time. (Decision support modification A)

    IG (B): Patients with a pathogenic BRCA1/2 mutation and unilateral breast cancer in their medical history receive a written decision support in paper format immediately after their genetic test results or in the further course of time. (Decision support modification B)

    Before the intervention and three and six months afterwards, the participants answer standardized questionnaires on decision- and knowledge-related and psychological parameters.
  •   Control group without decision aid.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   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

- Change in the stage of decision making between T1 and T2
- Change in knowledge about disease risks and preventive options between T1 and T2
- Change in psychological stress consequences, anxiety and depression symptoms between T1 and T2
- Use of the EH for decision making, acceptance of the EH on T2

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

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

  •   Female
  •   18   Years
  •   70   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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Addresses

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    • 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 KölnGebäude 70, CIO, 4. Etage
    • Ms.  Prof. Dr.  Rita  Schmutzler 
    • Kerperner Straße 62
    • 50937  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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Status

  •   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.