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

NCT ID: NCT00287898

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 669 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telephone Genetic Counseling

Participants randomized to this arm will receive all genetic counseling via telephone.

Group Type: EXPERIMENTAL

Telephone Genetic Counseling

Intervention Type: BEHAVIORAL

Participants will receive all genetic counseling via telephone

Usual Care

Participants randomized to usual care will receive standard in-person genetic counseling.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

subjects will receive standard in-person genetic counseling

Interventions

Telephone Genetic Counseling

Participants will receive all genetic counseling via telephone

Intervention Type: BEHAVIORAL

Usual Care

subjects will receive standard in-person genetic counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Schwartz, PhD

Role: STUDY_CHAIR

Lombardi Comprehensive Cancer Center

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mount Sinai School of Medicine

New York, New York, United States

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26455498 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24449235 (View on PubMed)

Other Identifiers

R01CA082346

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA108933

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA051008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GUMC-2004-133

Identifier Type: -

Identifier Source: secondary_id

CDR0000450959

Identifier Type: -

Identifier Source: org_study_id