Trial document




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  DRKS00015527

Trial Description

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Title

Evaluation of a decision coaching program for structured decision support in preference sensitive decisions of risk-adapted prevention for BRCA1/2 gene mutation carriers (EDCP-BRCA)

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Trial Acronym

EDCP-BRCA

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URL of the Trial

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Brief Summary in Lay Language

For BRCA1/2 mutation carriers, the decision between prophylactic surgeries and/or joining the screening program is based upon age of the woman, memories of family cancers, fertility and desire to have children, caring for children, close relationships, body image, ongoing risk and survival, among others. This study supports healthy female BRCA1/2 mutation carriers to make a decision concerning their individual risk for breast and ovarian cancer through a decision coaching provided by a specialized breast care nurse. The decision coaching promotes active involvement in the decision making, as well as higher satisfaction with the decision making process.

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Brief Summary in Scientific Language

Around 70,000 women are newly diagnosed with breast cancer each year in Germany alone. Additionally another 7,800 women are newly diagnosed with ovarian cancer. In around 30% of these cases there is a familial clustering for these cancer types. 25% of these women carry a BRCA 1/2 gene mutation. Women with this gene mutation have an elevated risk for breast and ovarian cancer throughout their lifetime. These women have multiple options of preventive care. For example, they can have their breasts or ovaries surgically removed or participate in an intensive mammography screening program. To make a decision about their preventive options, women need to be fully informed and counseled.
The current project aims at supporting affected women with their decision process with an individual decision coaching session. The goal is to improve understanding of benefits and risks of all preventive options. In turn, this should lead to a higher decision competence and quality.
The effectiveness of the decision coaching will be evaluated in six centers for familial breast and ovarian cancer Germany-wide through a randomized-controlled trial (RCT). Around 400 women will participate in the study. Women newly diagnosed with a BRCA 1/2 gene mutation will be recruited through the attending physician and randomized into experimental or control group. Women in the control group will receive standard routine care, while women in the experimental group will receive the decision coaching. The decision coaching will be implemented by specialized breast care nurses. The project is funded for 3 years with EUR 2,067,660,00.
If the decision coaching program will reliably improve the decision quality, it can be integrated into routine care in the centers for familial breast and ovarian cancer.

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Organizational Data

  •   DRKS00015527
  •   2019/10/30
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  •   yes
  •   Approved
  •   19-1110, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   ICD-10-CM: Z15.01
  •   BRCA1/2 gene mutation, no prior history of breast and/or ovarian cancer
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Interventions/Observational Groups

  •   Women in the intervention group receive an individualized decision coaching by specialized breast care nurses.
  •   Women in the control group receive usual care, consisting of risk counselling and information material.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

The primary outcome of the study is the congruence between the preferred and actual role in the decision-making process. Questionnaire data will be gathered from participants at three different points in time. T1 is measured one week after getting the genetic result, T2 is measured 12 weeks after getting the genetic result and T3 six months after getting the genetic result. The primary outcome will be the difference between T1 and T2.

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Secondary Outcome

Secondary outcomes are satisfaction with the actual role, decisional conflict, knowledge and attitude towards preventions strategies, stage of decision making, symptoms of anxiety and depression, coping self-efficacy, subjective impact of the test result and self-concept of BRCA1/2 carriers.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/11/01
  •   399
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

BRCA1/2 gene mutation

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Exclusion Criteria

cancer diagnosis, heart condition, severe mental illness and/or suicidal, insufficient German

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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, Universitätsklinikum Köln
    • Ms.  Anna  Isselhard 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    • Institut für Gesundheitsökonomie und klinische Epidemiologie, Universitätsklinikum Köln
    • Ms.  Anna  Isselhard 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Wegelystr.
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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