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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685256
• Other study ID #: CDR0000592726
• Secondary ID: R01HG002686P30CA
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2008
• Last updated: May 16, 2017
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• counseling intervention
subjects and parents will receive genetic counseling
• educational intervention
subjects and parents will receive education re: genetic testing
• survey administration
surveys will be administered to subjects and parents

Behavioral:
• psychosocial assessment and care
psychosocial assessment and counseling will be provided
• supportive care
parents and children will be provided with supportive care

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington, D.C.	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

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