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

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

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.

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.

Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months

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

Peshkin BN, Kelly S, Nusbaum RH, Similuk M, DeMarco TA, Hooker GW, Valdimarsdottir HB, Forman AD, Joines JR, Davis C, McCormick SR, McKinnon W, Graves KD, Isaacs C, Garber J, Wood M, Jandorf L, Schwartz MD. Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. J Genet Couns. 2016 Jun;25(3):472-82. doi: 10.1007/s10897-015-9897-6. Epub 2015 Oct 12.

Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21.