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

NCT00287898 | Completed

• 5 other identifiers: CDR0000450959R01CA082346R01CA108933P30CA051008GUMC-2004-133
• Study Type: interventional
• Target: 669
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (5)

• Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months

  6 months

• Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months

  3 months

• Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months

  3 months

• Quality of life as assessed by SF-12 health survey at 3 and 6 months

  6 months

• Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months

  6 months

Secondary Outcomes (2)

• Costs by cost measurement post-counseling

  6 months

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

  12 months

Study Arms (2)

Telephone Genetic Counseling

EXPERIMENTAL

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

Behavioral: Telephone Genetic Counseling

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

Telephone Genetic Counseling BEHAVIORAL

Participants will receive all genetic counseling via telephone

Telephone Genetic Counseling

Usual Care BEHAVIORAL

subjects will receive standard in-person genetic counseling

Usual Care

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Georgetown University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

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

Boston, Massachusetts, 02115-6084, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110, United States

Location

Related Publications (2)

• 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.

  PMID: 26455498 DERIVED

• 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.

  PMID: 24449235 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc Schwartz, PhD

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: May 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2014
• Last Updated: April 7, 2017

Record last verified: 2017-02

Locations

US (4)