NCT00685256

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 8 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Hereditary Breast/Ovarian Cancer (brca1, brca2)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-02-01
• Completion: 2015-12-01
• First posted: 2008-05-28
• Last updated: 2017-05-17

Locations

2 sites across 1 country: United States