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Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients (TIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00783822
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : November 9, 2012
UMC Utrecht
Fonds NutsOhra
Information provided by (Responsible Party):
Neil Aaronson, The Netherlands Cancer Institute

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.

Condition or disease Intervention/treatment
Breast Neoplasms Other: RGCT

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Behavioral and Psychosocial Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients: a Multicenter Study
Study Start Date : November 2008
Primary Completion Date : January 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
rapid genetic counseling and testing
Other: RGCT
rapid genetic counseling and testing
No Intervention: control
usual care

Primary Outcome Measures :
  1. The choice of primary surgical treatment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Psychosocial effects [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783822

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Sponsors and Collaborators
The Netherlands Cancer Institute
UMC Utrecht
Fonds NutsOhra
Principal Investigator: N. K. Aaronson, PhD The Netherlands Cancer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neil Aaronson, Head, Department of Psychosocial Research, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT00783822     History of Changes
Other Study ID Numbers: NL24252.031.08
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Neil Aaronson, The Netherlands Cancer Institute:
breast neoplasms
genetic counseling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases