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

NCT00685256 | Completed Phase 3

• 4 other identifiers: CDR0000592726R01HG002686P30CA051008GUMC-2007-444
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

breast cancer; hereditary breast/ovarian cancer (BRCA1, BRCA2)

Outcome Measures

Primary Outcomes (13)

• 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

Interventions

counseling intervention OTHER

subjects and parents will receive genetic counseling

educational intervention OTHER

subjects and parents will receive education re: genetic testing

survey administration OTHER

surveys will be administered to subjects and parents

psychosocial assessment and care BEHAVIORAL

psychosocial assessment and counseling will be provided

supportive care BEHAVIORAL

parents and children will be provided with supportive care

Eligibility Criteria

• Age: 8 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Georgetown University: lead
• National Cancer Institute (NCI): collaborator
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (2)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Counseling; Early Intervention, Educational; Psychiatric Rehabilitation; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Rehabilitation; Therapeutics; Patient Care

Study Officials

• Kenneth Tercyak, PhD

  Lombardi Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2015
• Last Updated: May 17, 2017

Record last verified: 2017-02

Locations

US (2)