Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001806
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
1999-11-03
Brief Title:
Methods in Education for Breast Cancer Genetics
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Methods in Education for Breast Cancer Genetics
Status:
COMPLETED
Status Verified Date:
2017-12-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 breastovarian cancer syndrome risks benefits and limitations of BRCA1BRCA2 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
Detailed Description:
In October 1995 the National Naval Medical Center opened the only Department of Defense funded Breast Care Center BCC Within less than one year the Center was seeing 100 - 200 new patients per week and making 10 - 20 new diagnoses of breast cancer per month In 1997 we began conducting germline testing for BRCA1 and BRCA2 under an approved Navy IRB study To date 51 individuals have enrolled into the Education and Counseling component and 42 individuals have elected to receive germline testing Early on it became apparent that a more time efficient approach to education and counseling would be required if access to information on breast cancer genetics was to be made available to a larger population Traditionally education and counseling has been offered on a one to one basis prior to germline testing Often hours are spent with an individual At some centers multiple visits are standard Not only is there a shortage of health care providers trained in cancer genetics but even if there were an abundance of trained providers the time and cost as well as need for efficiency would preclude this type of approach Thus this approach is not applicable to most health care delivery systems We began offering education in small groups approximately 18 months ago using the same informational content that we use in our one to one sessions Based on preliminary nonrandomized results there appeared to be no difference in learning and general patient satisfaction based on results of pre- and post-test administered before and after the education It was our contention that group education is equivalent and in some situations better than individual education Therefore we will conduct a randomized trial designed to test equivalence between individual and group education
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0081 | None | None | None |