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

NCT00685256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2017-05-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH

  • Georgetown University

    lead OTHER

Principal Investigators

  • Kenneth Tercyak, PhD · Lombardi Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2013-02-28
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685256 on ClinicalTrials.gov