Clinical trial · Interventional
Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients
Behavioral and Psychosocial Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients: a Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been completed (e.g. the first year after diagnosis). For women with a mutation in one of the two breast-ovarian cancer syndrome genes, chances of a second breast cancer are high, and therefore a proportion of these women may opt for preventive measures in addition to their immediate breast cancer treatment. Contralateral prophylactic mastectomy significantly reduces this risk, and is associated with a reduction in mortality. Genetic counseling and testing for breast cancer typically takes approximately 4-6 months to complete. However, some hospitals and laboratories are now able to generate test results within 3 to 6 weeks. This technology of rapid genetic testing creates new opportunities for providing both women and their treating surgeons with information potentially relevant for deciding between available treatment options, including type of surgery and adjuvant therapy. The study will focus on newly diagnosed breast cancer patients who, prior to receiving treatment, are identified as having at least a 10% risk of carrying a mutation in the BRCA1 or BRCA2 genes. We will investigate whether women with a recent diagnosis of breast cancer make use of rapid genetic counseling when offered. Furthermore, we will investigate whether the process of genetic counseling (and subsequent DNA testing) has influence on the choice of treatment, and whether and how such rapid genetic counseling and testing (RGCT) affects levels of risk perception, cancer-related worries and distress, and decisional satisfaction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RGCT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- intervention
- description
- rapid genetic counseling and testing
- interventionNames
- Other: RGCT
- type
- NO_INTERVENTION
- label
- control
- description
- usual care
Primary outcomes (1)
- measure
- The choice of primary surgical treatment
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Psychosocial effects
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed breast cancer * 10% or higher chance of carrying BRCA1/2 gene mutation Exclusion Criteria: * age \<18 years * does not speak Dutch
References
Publications (2)
- DERIVEDWevers MR, Aaronson NK, Verhoef S, Bleiker EM, Hahn DE, Kuenen MA, van der Sanden-Melis J, Brouwer T, Hogervorst FB, van der Luijt RB, Valdimarsdottir HB, van Dalen T, Theunissen EB, van Ooijen B, de Roos MA, Borgstein PJ, Vrouenraets BC, Vriens E, Bouma WH, Rijna H, Vente JP, Witkamp AJ, Rutgers EJ, Ausems MG. Impact of rapid genetic counselling and testing on the decision to undergo immediate or delayed prophylactic mastectomy in newly diagnosed breast cancer patients: findings from a randomised controlled trial. Br J Cancer. 2014 Feb 18;110(4):1081-7. doi: 10.1038/bjc.2013.805. Epub 2014 Jan 14. PMID 24423928
- DERIVEDWevers MR, Ausems MG, Verhoef S, Bleiker EM, Hahn DE, Hogervorst FB, van der Luijt RB, Valdimarsdottir HB, van Hillegersberg R, Rutgers EJ, Aaronson NK. Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: design of a multicenter randomized clinical trial. BMC Cancer. 2011 Jan 10;11:6. doi: 10.1186/1471-2407-11-6. PMID 21219598