Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients (TIME)
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Purpose
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 | Intervention |
|---|---|
|
Breast Neoplasms |
Other: RGCT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Behavioral and Psychosocial Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients: a Multicenter Study |
- The choice of primary surgical treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Psychosocial effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 265 |
| Study Start Date: | November 2008 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
intervention
rapid genetic counseling and testing
|
Other: RGCT
rapid genetic counseling and testing
|
|
No Intervention: control
usual care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands | |
| Principal Investigator: | N. K. Aaronson, PhD | The Netherlands Cancer Institute |
More Information
No publications provided by The Netherlands Cancer Institute
Additional 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, SNO-T-0701-95 |
| Study First Received: | October 31, 2008 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by The Netherlands Cancer Institute:
|
breast neoplasms genetic counseling |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013