Genetic testing in breast cancer patients based on a home information package: DNA-direct.
Recruiting
- Conditions
- BRCA1/2, breast cancer, borstkanker, hereditary breast cancer, erfelijke borstkanker
- Registration Number
- NL-OMON22096
- Lead Sponsor
- MC St Radboud / Radboud University Medical Center (Nijmegen)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
All female breast cancer patients (recently diagnosed or in the past) referred to the department of Clinical Genetics of the Radboud University Medical Centre Nijmegen for genetic counseling.
Exclusion Criteria
1. Problems with (large amounts of) written Dutch text;
2. Current psychological / psychiatric treatment (including medication);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Satisfaction of the patient (i.e. RIVM-questionnaire, Decisional Conflict Scale, open-ended questions);<br /><br>2. Psychological / psychosocial burden of the patient (i.e. Impact of Event Scale, questions regarding quality of life (selected from EORTC-QLQ C30), GHQ-12, Cancer Worry Scale, risk perception of hereditary and recurrent breast cancer on a scale of 0-100%).
- Secondary Outcome Measures
Name Time Method 1. Factors that determine the patient’s choice for or against the DNA-direct procedure (i.e. demographic information, Empowerment (NEV-bk), open-ended questions);<br /><br>2. Waiting and processing times;<br /><br>3. Family characteristics of detected families with a mutation in the BRCA1 or BRCA2 gene (i.e. ODHCF).