iKNOW - an interventional study to improve counseling of BRCA1/2 mutation carriers

iKNOW - an interventional study to improve counseling of BRCA1/2 mutation carriers - iKNOW

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020914

Enrollment

200

Registered

2020-03-12

Start date

2019-12-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA1/2 mutation

Interventions

Group 1: Women in the Intervention group receive counseling in compliance with the guidelines, supported by an online counseling tool and access to the tool for 6 months after counseling. Due to the C

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: BRCA1/2 Mutation, access to a computer

Exclusion criteria

Exclusion criteria: risk counseling taken place, insufficient knowledge of german language, severe psychiatric disorder

Design outcomes

Primary

Measure	Time frame
Primary outcome is the objective risk comprehension of the 10-year risk of developping breast and ovarian cancer at T3 (6 months after counseling), assessment via questionnaire	—

Secondary

Measure	Time frame
Secondary outcomes are also gathered via questionnaire. Measurement Points are before counseling (T0), directly after counseling (T1), 4 weeks after counseling (T2) and 6 months after counseling (T3). 1. Change in risk comprehension of the 10-year risk of developping breast and ovarian cancer in the course of 6 months (T1, T2, and T3) 2. Change of the emotional subjective risk perception (T1, T2, T3) 3. Risk knowledge (T1, T2, T3) 4. Health anxiety (Lerman Cancer Worry Scale; T1, T2, T3) 5. State anxietey (STAI-SKD; T1, T2, T3) 6. Quality of life (SF-12 subscale general health perception) 7. Utilisation of medical Services (T2, T3) 8. Satisfaction with counseling (ZUF-8, adapted, T1, T3) 9. Usability of the counseling tool (meCUE scales usability, usefulness and visual aesthetics; T1, T3) 10. Evaluation of counseling Contents (T1, T2, T3) Due to the Corona-pandemic part of the Survey consists of paper-pencil questionnaires and part of online questionnaires. This deviation is documented and considered in the analyses.	—

Measure

Time frame

Secondary outcomes are also gathered via questionnaire. Measurement Points are before counseling (T0), directly after counseling (T1), 4 weeks after counseling (T2) and 6 months after counseling (T3). 1. Change in risk comprehension of the 10-year risk of developping breast and ovarian cancer in the course of 6 months (T1, T2, and T3) 2. Change of the emotional subjective risk perception (T1, T2, T3) 3. Risk knowledge (T1, T2, T3) 4. Health anxiety (Lerman Cancer Worry Scale; T1, T2, T3) 5. State anxietey (STAI-SKD; T1, T2, T3) 6. Quality of life (SF-12 subscale general health perception) 7. Utilisation of medical Services (T2, T3) 8. Satisfaction with counseling (ZUF-8, adapted, T1, T3) 9. Usability of the counseling tool (meCUE scales usability, usefulness and visual aesthetics; T1, T3) 10. Evaluation of counseling Contents (T1, T2, T3) Due to the Corona-pandemic part of the Survey consists of paper-pencil questionnaires and part of online questionnaires. This deviation is documented and considered in the analyses.

—

Countries

Germany

Contacts

Public ContactCaren Hilger

Charité – Universitätsmedizin Berlin, Institut für Geschlechterforschung in der Medizin (GIM), Forschungsgruppe Prävention

caren.hilger@charite.de+49 (0) 30 450 525326

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026