Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children

• Self-reported outcomes at 1-and 6-months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Decision conflict, as assessed by the Decisional Conflict Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Decision quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Disclosure of genetic testing results by parents [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Parents' preferences and values regarding family communication of genetic test results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Cognitive appraisals [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  

Other: counseling intervention
subjects and parents will receive genetic counseling
Other: educational intervention
subjects and parents will receive education re: genetic testing
Other: survey administration
surveys will be administered to subjects and parents
Behavioral: psychosocial assessment and care
psychosocial assessment and counseling will be provided
Behavioral: supportive care
parents and children will be provided with supportive care

OBJECTIVES:

Primary

• To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.

Secondary

• To understand the mechanisms by which decision support impacts on decision outcomes.
• To identify mothers who are most and least likely to benefit from decision support.
• To explore the potential impact of decision support on disclosure and parent-child psychosocial well-being.

OUTLINE: This is a multicenter study. Mothers are stratified according to their child's age (< 13 vs ≥ 13 years old), child's gender (female vs male), and trial site. Mothers are randomized to 1 of 2 arms.

• Arm I (standard genetic counseling with communication aid): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "My Children, My Test Results," a detailed decision guide developed to promote quality and informed decision making and outcomes, and provide support to mothers regardless of whether or not they choose to communicate their BRCA1/2 test results to their children.
• Arm II (standard genetic counseling alone): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "Genetic Testing for Breast and Ovarian Cancer Risk: It's Your Choice" containing information regarding family history of breast and ovarian cancer risks, BRCA1/2 genes, risks and benefits of genetic testing, medical management options for carriers, and considerations including family communication.

All mothers complete extensive family history assessments during their baseline interviews and disclose if they have been diagnosed with cancer, length and type of treatments, and the number of other relatives with a history of cancer. Mothers are assessed at baseline (pre-test genetic counseling), post-genetic counseling after learning test results, and at 1 and 6 months post-genetic counseling by a 30-45 minute multi-item and multi-scale self-report telephone survey. Genetic testing results are also submitted to this study. The frequency (number), intensity (length in minutes), and content of participant-initiated telephone contacts to genetic counselors to assess intervention reactivity; participants' self-reported use of educational guides; and their satisfaction with the intervention will be assessed.