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

Study Overview
=================
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.

Official Title
-----------------
Telephone-Based Genetic Counseling; An Equivalence Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Telephone Genetic Counseling
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Genetic Counseling<br>Participants randomized to this arm will receive all genetic counseling via telephone. | Behavioral: Telephone Genetic Counseling<br>* Participants will receive all genetic counseling via telephone<br>|
| Active Comparator: Usual Care<br>Participants randomized to usual care will receive standard in-person genetic counseling. | Behavioral: Usual Care<br>* subjects will receive standard in-person genetic counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer