Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children
- 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
- 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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Self-reported outcomes at 1-and 6-months
Kenneth Tercyak, PhD
Lombardi Cancer Research Center
United States: Food and Drug Administration
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|