Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations

Breast Cancer Clinical Trial

Official title:

Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416754
• Other study ID #: CDR0000450754
• Secondary ID: R01CA082346P30CA
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: April 5, 2017
• Start date: December 2000
• Est. completion date: December 2006

Study information

• Verified date: February 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.

PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.

Description:

OBJECTIVES:

• Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.

• Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.

• Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.

• Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.

• Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.

OUTLINE: This is a multicenter study.

Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.

• Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.

• Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.

Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.

PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1109
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation

• Prior diagnosis of breast cancer allowed

• Must not be undergoing active treatment

• Patients with prior bilateral mastectomy are eligible for study but not eligible for randomization

PATIENT CHARACTERISTICS:

• Female only

• No psychiatric or cognitive disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• counseling intervention
subjects will receive genetic counseling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction	subjects will complete questionnaires re; genetic counseling experience	1 year