Status:

COMPLETED

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

Lead Sponsor:

Georgetown University

Collaborating Sponsors:

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

Conditions:

Breast Cancer

Hereditary Breast/Ovarian Cancer (brca1, brca2)

Eligibility:

FEMALE

8-120 years

Phase:

PHASE3

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 childre...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2015

    Estimated Enrollment :

    245 Patients enrolled

    Trial Details

    Trial ID

    NCT00685256

    Start Date

    March 1 2008

    End Date

    December 1 2015

    Last Update

    May 17 2017

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

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

    2

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

    Boston, Massachusetts, United States, 02115