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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Hereditary Breast/Ovarian Cancer (brca1, brca2)
• Intervention / Treatment: Other: counseling intervention; Other: educational intervention; Other: survey administration; Behavioral: psychosocial assessment and care; Behavioral: supportive care

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.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
      • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Cancer Institute (NCI); National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 24, 2008
• First Submitted That Met QC Criteria: May 24, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; hereditary breast/ovarian cancer (BRCA1, BRCA2)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: CDR0000592726; P30CA051008 (U.S. NIH Grant/Contract); R01HG002686 (U.S. NIH Grant/Contract); GUMC-2007-444