CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 170 enrolled
Drug / intervention
Genetic Education and Counseling +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001806
NCT00001806Phase 3Completed

Methods in Education for Breast Cancer Genetics

National Cancer Institute (NCI)·interventional·Posted Nov 4, 1999·Updated Dec 12, 2019

In Brief

A Phase 3 clinical trial evaluating Genetic Education and Counseling for Breast Cancer and Ovarian Cancer. Completed, enrolled 170 participants across 1 site.

Detailed Summary

In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer genetics program at the National Naval Medical Center s Breast Care Center. Genetic education, counseling, and germline testing for BRCA1 and BRCA2, two genes which confer increased lifetime risks for breast and ovarian cancer, were offered under a Navy IRB-approved study. Sixty participants received education and counseling on that protocol, 49 of whom chose to have genetic testing. The education and counseling, provided by oncology nurses trained in cancer genetics, focused on preparing participants to make well-informed decisions about testing. Included were information on cancer and genetics; hereditary breast/ovarian cancer syndrome; risks, benefits and limitations of BRCA1/BRCA2 testing; and screening and risk reduction options for high-risk individuals. Through our experience with this study, we devised two different methods of providing this information. Both of these methods were well received and appear to be equally effective, as measured by knowledge assessments before and after the sessions and subjective evaluation by the participants. We will now study them in a randomized fashion in the current protocol, to better evaluate whether one method is preferable. Ultimately we hope to be able to make recommendations that will allow for access to genetic education and counseling for more individuals in a more cost efficient manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartApr 6, 1999
Primary CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 18.7 yearsPosted 26.7 years ago

Interventions

Genetic Education and Counselingother

Group Education and Counseling

Genetic Education and Counselingother

Individual Education and Counlseing