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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00287898
First received: February 6, 2006
Last updated: April 5, 2017
Last verified: February 2017
  Purpose

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 Intervention
Breast Cancer
Behavioral: Telephone Genetic Counseling
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Telephone-Based Genetic Counseling; An Equivalence Trial

Resource links provided by NLM:


Further study details as provided by Georgetown University:

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

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

Enrollment: 669
Actual Study Start Date: May 2005
Study Completion Date: January 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287898

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):
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00287898     History of Changes
Other Study ID Numbers: CDR0000450959
R01CA082346 ( US NIH Grant/Contract Award Number )
R01CA108933 ( US NIH Grant/Contract Award Number )
P30CA051008 ( US NIH Grant/Contract Award Number )
GUMC-2004-133
Study First Received: February 6, 2006
Last Updated: April 5, 2017

Keywords provided by Georgetown University:
breast cancer

ClinicalTrials.gov processed this record on April 27, 2017