NCT00416754

Brief Summary

RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment. PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,109

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
Last Updated

April 7, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

December 27, 2006

Last Update Submit

April 5, 2017

Conditions

Breast Cancer

Keywords

breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    subjects will complete questionnaires re; genetic counseling experience

    1 year

Interventions

counseling interventionOTHER

subjects will receive genetic counseling

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation * Prior diagnosis of breast cancer allowed * Must not be undergoing active treatment * Patients with prior bilateral mastectomy are eligible for study but not eligible for randomization PATIENT CHARACTERISTICS: * Female only * No psychiatric or cognitive disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marc Schwartz, PhD

    Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

December 1, 2000

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share