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

Telephone-Based Genetic Counseling; An Equivalence Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Telephone Genetic Counseling; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 669
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-6084
      • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Vermont
    • Burlington, Vermont, United States, 05405-0110
      • Vermont Cancer Center at University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Marc Schwartz, PhD, Lombardi Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2005
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 6, 2006
• First Submitted That Met QC Criteria: February 6, 2006
• First Posted (Estimate): February 7, 2006

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CDR0000450959; P30CA051008 (U.S. NIH Grant/Contract); R01CA082346 (U.S. NIH Grant/Contract); R01CA108933 (U.S. NIH Grant/Contract); GUMC-2004-133