Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00685256|
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2)||Other: counseling intervention Other: educational intervention Other: survey administration Behavioral: psychosocial assessment and care Behavioral: supportive care||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2008|
|Primary Completion Date :||February 2013|
|Study Completion Date :||December 2015|
Other: counseling intervention
- Self-reported outcomes at 1-and 6-months [ Time Frame: 6 months ]
- Decision conflict, as assessed by the Decisional Conflict Scale [ Time Frame: 6 months ]
- Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale [ Time Frame: 6 months ]
- Decision quality [ Time Frame: 6 months ]
- Disclosure of genetic testing results by parents [ Time Frame: 6 months ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children [ Time Frame: 6 months ]
- Parents' preferences and values regarding family communication of genetic test results [ Time Frame: 6 months ]
- Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale [ Time Frame: 6 months ]
- Cognitive appraisals [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685256
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, D.C., District of Columbia, United States, 20007|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Kenneth Tercyak, PhD||Lombardi Comprehensive Cancer Center|