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

Breast Cancer Clinical Trial

Official title:

Telephone-Based Genetic Counseling; An Equivalence Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287898
• Other study ID #: CDR0000450959
• Secondary ID: R01CA082346R01CA
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: April 5, 2017
• Start date: May 2005
• Est. completion date: January 2014

Study information

• Verified date: February 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. completion date: January 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Telephone Genetic Counseling
Participants will receive all genetic counseling via telephone
• Usual Care
subjects will receive standard in-person genetic counseling

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Mount Sinai School of Medicine	New York	New York
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months		6 months
Primary	Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months		3 months
Primary	Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months		3 months
Primary	Quality of life as assessed by SF-12 health survey at 3 and 6 months		6 months
Primary	Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months		6 months
Secondary	Costs by cost measurement post-counseling		6 months
Secondary	Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months		12 months