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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: counseling intervention
* Other: educational intervention
* Other: survey administration
* Behavioral: psychosocial assessment and care
* Behavioral: supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported outcomes at 1-and 6-months |  | 6 months | 
| Decision conflict, as assessed by the Decisional Conflict Scale |  | 6 months | 
| Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale |  | 6 months | 
| Decision quality |  | 6 months | 
| Disclosure of genetic testing results by parents |  | 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 |  | 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 |  | 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 |  | 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 |  | 6 months | 
| Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children |  | 6 months | 
| Parents' preferences and values regarding family communication of genetic test results |  | 6 months | 
| Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale |  | 6 months | 
| Cognitive appraisals |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2)