Breast Cancer
Conditions
Keywords
breast cancer
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.
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.
Interventions
BEHAVIORALTelephone Genetic Counseling
Participants will receive all genetic counseling via telephone
BEHAVIORALUsual Care
subjects will receive standard in-person genetic counseling
Sponsors
National Cancer Institute (NCI)
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knowledge assessed by genetic testing knowledge measure 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 |
| Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months | 6 months |
| Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months | 12 months |
| Costs by cost measurement post-counseling | 6 months |
Countries
United States
Outcome results
None listed