NCT00783822

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

October 31, 2008

Last Update Submit

November 8, 2012

Conditions

Breast Neoplasms

Keywords

breast neoplasmsgenetic counseling

Outcome Measures

Primary Outcomes (1)

  • The choice of primary surgical treatment

    1 year

Secondary Outcomes (1)

  • Psychosocial effects

    1 year

Study Arms (2)

intervention

OTHER

rapid genetic counseling and testing

Other: RGCT

control

NO INTERVENTION

usual care

Interventions

RGCTOTHER

rapid genetic counseling and testing

intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed breast cancer
  • % or higher chance of carrying BRCA1/2 gene mutation

You may not qualify if:

  • age \<18 years
  • does not speak Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

Related Publications (2)

  • Wevers 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: 24423928DERIVED

  • Wevers 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: 21219598DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • N. K. Aaronson, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Psychosocial Research, Division of Psychosocial Research & Epidemiology

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

NL(1)