Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Condition: Breast Cancer; Hereditary Breast/Ovarian Cancer (brca1, brca2)
MeSH terms: Ovarian Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: A study that evaluates the support of a decision guide used together with genetic
      counseling may improve communication between mothers undergoing BRCA1/2 testing and their
      minor-age children.

      PURPOSE: This randomized phase III trial is studying standard genetic counseling given
      together with a decision guide to see how well it works compared with genetic counseling
      alone in improving communication between mothers undergoing BRCA1/2 testing and their
      minor-age children.
    

Detailed description: 
      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.
    

Intervention name(s): counseling intervention; educational intervention; survey administration; psychosocial assessment and care; supportive care
Intervention type(s): Other; Other; Other; Behavioral; Behavioral
Intervention description(s): subjects and parents will receive genetic counseling; subjects and parents will receive education re: genetic testing; surveys will be administered to subjects and parents; psychosocial assessment and counseling will be provided; parents and children will be provided with supportive care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: breast cancer; hereditary breast/ovarian cancer (BRCA1, BRCA2)