Ignite Creation Date:
2024-05-05 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00783822
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2008-10-31
Brief Title:
Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Behavioral and Psychosocial Effects of Rapid Genetic Counseling and Testing in Newly Diagnosed Breast Cancer Patients a Multicenter Study
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIME
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 eg 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
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
Detailed Description:
In the Netherlands approximately 12000 women are diagnosed with breast cancer annually of whom about 5-10 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 eg 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
This multicenter study will employ a randomized controlled trial In an 18 month period newly diagnosed breast cancer patients will be recruited from 13 hospitals in the Amsterdam and Utrecht regions of the Netherlands Eligible patients will be randomized either to the usual care UC arm of the study or to the RGCT arm of the study The randomization will be done in a ratio of 12
Women in the RGCT arm of the study will be referred for genetic counseling within a week after diagnosis prior to the primary surgery
Women in the UC condition will receive standard advice and care from their treating physician
Standardized questionnaires will be administered to all patients at study entry and at 6 and 12 months to assess all psychosocial outcomes The endpoints will include
1 the choice of clinical management strategy including the uptake of direct bilateral mastectomy BLM or of delayed preventive contralateral mastectomy PCM
2 cancer risk perception cancer-related worry and distress
3 knowledge of genetic aspects of breast cancer
4 decisional satisfaction and
5 health-related quality of life HRQL The study will also evaluate womens experience of and satisfaction with RGCT ie the timing and quality of the services provided the perceived impact on treatment decisions perceived need for additional psychosocial services etc Data on surgical outcomes will be abstracted from the medical records A subset of women will be interviewed to obtain supplementary qualitative data about the RGCT experience
This study will provide essential information about the impact of RGCT on the choice of primary surgical treatment among women with breast cancer with an increased risk that their cancer has a hereditary basis and about the psychosocial effects of the RGCT process and the ensuing treatment decisions It will inform clinical geneticists surgeons and patients about the potential benefits and risks of RGCT and will be useful in further shaping the content and process of genetic counseling in the diagnostic and early treatment phase of breast cancer
The study will also yield recommendations for improving the quality of the multidisciplinary care provided in breast cancer clinics by the addition of genetic expertise when patients are at relatively high risk of having a genetic predisposition for breast cancer
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
This multicenter study will employ a randomized controlled trial In an 18 month period newly diagnosed breast cancer patients will be recruited from 13 hospitals in the Amsterdam and Utrecht regions of the Netherlands Eligible patients will be randomized either to the usual care UC arm of the study or to the RGCT arm of the study The randomization will be done in a ratio of 12
Women in the RGCT arm of the study will be referred for genetic counseling within a week after diagnosis prior to the primary surgery
Women in the UC condition will receive standard advice and care from their treating physician
Standardized questionnaires will be administered to all patients at study entry and at 6 and 12 months to assess all psychosocial outcomes The endpoints will include
1 the choice of clinical management strategy including the uptake of direct bilateral mastectomy BLM or of delayed preventive contralateral mastectomy PCM
2 cancer risk perception cancer-related worry and distress
3 knowledge of genetic aspects of breast cancer
4 decisional satisfaction and
5 health-related quality of life HRQL The study will also evaluate womens experience of and satisfaction with RGCT ie the timing and quality of the services provided the perceived impact on treatment decisions perceived need for additional psychosocial services etc Data on surgical outcomes will be abstracted from the medical records A subset of women will be interviewed to obtain supplementary qualitative data about the RGCT experience
This study will provide essential information about the impact of RGCT on the choice of primary surgical treatment among women with breast cancer with an increased risk that their cancer has a hereditary basis and about the psychosocial effects of the RGCT process and the ensuing treatment decisions It will inform clinical geneticists surgeons and patients about the potential benefits and risks of RGCT and will be useful in further shaping the content and process of genetic counseling in the diagnostic and early treatment phase of breast cancer
The study will also yield recommendations for improving the quality of the multidisciplinary care provided in breast cancer clinics by the addition of genetic expertise when patients are at relatively high risk of having a genetic predisposition for breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SNO-T-0701-95 | None | None | None |