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

Georgetown University

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Usual Care; Behavioral: Telephone Genetic Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00287898

P30CA051008 (U.S. NIH Grant/Contract)

R01CA108933 (U.S. NIH Grant/Contract)

CDR0000450959

GUMC-2004-133

R01CA082346 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 669 patients

Sex: Female

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

669 participants in 2 patient groups

Telephone Genetic Counseling

Experimental group

Description:

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

Treatment:

Behavioral: Telephone Genetic Counseling

Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care