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

Not Applicable

• Conditions: C50; C56; Malignant neoplasm of breast; Malignant neoplasm of ovary

• Registration Number: DRKS00015823
• Lead Sponsor: niversitätsklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-14
• Results First Posted: 2021-06-05
• Study Completion: 2022-03-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 450

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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