DNA testing for BRCA1/2 in breast cancer patients prior to genetic counseling: DNA-direct

Completed

• Conditions: BRCA gene mutation; hereditary breast cancer; 10006291; 10083624

• Registration Number: NL-OMON35994
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

All female breast cancer patients (recently diagnosed or in the past) referred to Human Genetics of the Radboud University Medical Centre Nijmegen for genetic counseling.

Exclusion Criteria

For the DNA-direct procedure: problems with (large amounts of) written Dutch text, current psychological / psychiatric treatment (including medication), problems with family communication about cancer as estimated by the patient.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Satisfaction of the patient regarding genetic testing and counseling<br /><br>Psychological / psychosocial burden of the patient regarding genetic testing<br /><br>and counseling</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Factors that determine the patient*s choice for or against the DNA-direct<br /><br>procedure<br /><br>Waiting and processing times<br /><br>Family characteristics of detected families with a mutation or a so-called<br /><br>unclassified variant type 3 (UV-III) in the BRCA1 or BRCA2 gene</p><br>