Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Conditions
Breast Cancer - Hereditary Breast/Ovarian Cancer (brca1, brca2)
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2)
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Intervention
Name: counseling intervention Type: Other
Name: educational intervention Type: Other
Name: survey administration Type: Other
Name: psychosocial assessment and care Type: Behavioral
Name: supportive care Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 8 Years
Gender: Female
Criteria: DISEASE CHARACTERISTICS:

- Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old)

- Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations

- Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months

PATIENT CHARACTERISTICS:

- At least 21 years old (mothers)

- No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent

- Must be able to adequately understand, speak, and read English

- Must have ready and consistent access to a telephone

PRIOR CONCURRENT THERAPY:

- Not specified
Locations
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States
Status: Recruiting
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center - 202-444-0381
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Andrea Farkas Patenaude, PhD - 617-632-3314 - andrea_patenaude@dfci.harvard.edu
Start Date
March 2008
Completion Date
December 2015
Sponsors
Georgetown University
Source
Georgetown University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page