Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation - Full Text View

Sponsors and Collaborators:	Lombardi Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00287898

Purpose

RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

Condition	Intervention	Phase
Breast Cancer	Procedure: counseling Procedure: mutation analysis	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Genetic Counseling

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized
Official Title:	Telephone-Based Genetic Counseling; An Equivalence Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months [ Designated as safety issue: No ]
Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months [ Designated as safety issue: No ]
Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months [ Designated as safety issue: No ]
Quality of life as assessed by SF-12 health survey at 3 and 6 months [ Designated as safety issue: No ]
Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Costs by cost measurement post-counseling [ Designated as safety issue: No ]
Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	May 2005
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.

Secondary

Identify participant characteristics that predict differential response to TGC.
Explore the mechanisms by which TGC or SGC impact distress and quality of life.

OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.

Group 1 (standard genetic counseling): Participants undergo an in-person genetic counseling session. Participants are then given the option of providing blood for genetic testing at the study site. Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor.
Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based genetic counseling session. Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail. Participants receive their results over the phone from their genetic counselor.

After completion of genetic counseling, all participants are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:
- First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation
- Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased)
- Obligate gene carrier or affected woman
Must live within 100 miles of the Lombardi Comprehensive Cancer Center
No more than 4 weeks since breast or ovarian cancer diagnosis
No metastatic or inflammatory breast cancer or ovarian cancer
No stage III breast or ovarian cancer while undergoing concurrent chemotherapy

PATIENT CHARACTERISTICS:

No psychiatric illness or cognitive disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

No prior genetic counseling or testing for BRCA1 and/or BRCA2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287898

Locations

United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115-6084
Contact: Judy Garber, MD 617-632-2282 judy_garber@dfci.harvard.edu
United States, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Contact: Clinical Trials Office - Mount Sinai School of Medicine 212-659-8050
United States, Vermont
Vermont Cancer Center at University of Vermont	Recruiting
Burlington, Vermont, United States, 05405-0110
Contact: Clinical Trials Office - Vermont Cancer Center at University o 802-656-2178

Sponsors and Collaborators

Lombardi Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Marc Schwartz, PhD

Lombardi Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center ( Marc Schwartz )
Study ID Numbers:	CDR0000450959, GUMC-2004-133
Study First Received:	February 6, 2006
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00287898
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009