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

This study has been completed.
Sponsor:
Collaborators:
UMC Utrecht
NutsOHRA Fund
Information provided by (Responsible Party):
Neil Aaronson, The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00783822
First received: October 31, 2008
Last updated: November 8, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • The choice of primary surgical treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

  Hide Detailed Description

Detailed Description:

In the Netherlands, approximately 12,000 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 (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.

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 1:2

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 women's experience of and satisfaction with RGCT (i.e., 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783822

Locations
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Sponsors and Collaborators
The Netherlands Cancer Institute
UMC Utrecht
NutsOHRA Fund
Investigators
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 July 28, 2014