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

• ClinicalTrials.gov Identifier: NCT00287898
• Recruitment Status: Completed
• First Posted: February 7, 2006
• Last Update Posted: April 7, 2017
• Sponsor: Georgetown University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Georgetown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Behavioral: Telephone Genetic Counseling; Behavioral: Usual Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 669 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Telephone-Based Genetic Counseling; An Equivalence Trial
• Actual Study Start Date: May 2005
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telephone Genetic Counseling; Participants randomized to this arm will receive all genetic counseling via telephone.	Behavioral: Telephone Genetic Counseling; Participants will receive all genetic counseling via telephone
Active Comparator: Usual Care; Participants randomized to usual care will receive standard in-person genetic counseling.	Behavioral: Usual Care; subjects will receive standard in-person genetic counseling

Outcome Measures

Primary Outcome Measures :

1. Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months [ Time Frame: 6 months ]
2. Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months [ Time Frame: 3 months ]
3. Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months [ Time Frame: 3 months ]
4. Quality of life as assessed by SF-12 health survey at 3 and 6 months [ Time Frame: 6 months ]
5. Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Costs by cost measurement post-counseling [ Time Frame: 6 months ]
2. Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 85 Years (Adult, Older Adult)
• Sexes 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

Locations

United States, District of Columbia

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

United States, Massachusetts

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

Boston, Massachusetts, United States, 02115-6084

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

United States, Vermont

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States, 05405-0110

Sponsors and Collaborators

Georgetown University

National Cancer Institute (NCI)

Investigators

• Study Chair: Marc Schwartz, PhD; Lombardi Comprehensive Cancer Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Georgetown University
• ClinicalTrials.gov Identifier: NCT00287898
• Other Study ID Numbers: CDR0000450959; R01CA082346 ( U.S. NIH Grant/Contract ); R01CA108933 ( U.S. NIH Grant/Contract ); P30CA051008 ( U.S. NIH Grant/Contract ); GUMC-2004-133
• First Posted: February 7, 2006
• Last Update Posted: April 7, 2017
• Last Verified: February 2017

Keywords provided by Georgetown University:

breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases