C50 C56
Conditions
Interventions
Group 1: 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
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Germany
Contacts
Public ContactRita Schmutzler
Zentrum Familiärer Brust- und Eierstockkrebs Universitätsklinikum KölnGebäude 70, CIO, 4. Etage
Outcome results
None listed