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Related Studies
Comparison of Two Methods of Genetics Education and Counseling for Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: March 2, 2007   No Changes Posted
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019877
  Purpose

RATIONALE: Genetics education and counseling may be effective when provided by two different methods.

PURPOSE: Randomized clinical trial to compare the effectiveness of two methods of education and counseling for participants who may undergo genetic testing for breast cancer.


Condition Intervention
Ovarian Epithelial Cancer
Male Breast Cancer
Breast Cancer
Procedure: Genetic Analysis

Study Type: Interventional
Study Design: Treatment
Official Title: Randomized Study of Methods in Education for Breast Cancer Genetics

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1999
Detailed Description:

OBJECTIVES:

I. Compare the effect of two different methods of providing education to persons enrolling in a breast cancer genetics program.

PROTOCOL OUTLINE: This is a randomized study. Participants are randomized to one of two different education methods.

All participants complete a pretest questionnaire, then attend a breast cancer genetics education and counseling session. A posttest questionnaire is also completed. Participants may then choose to undergo germline BRCA testing. Participants are followed at 1 week and 3, 6, and 12 months after receiving results of BRCA germline testing.

PROJECTED ACCRUAL:

A total of 120 participants (60 per arm) will be accrued for this study within 18-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of breast cancer or ductal carcinoma in situ at age 45 or under OR Diagnosis of ovarian cancer at age 50 or under OR Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer and ovarian cancer in the same individual OR Diagnosis of breast or ovarian cancer AND At least one first or second degree relative with breast cancer diagnosed at age 45 or under or ovarian cancer at age 50 or under OR Three relatives in the same lineage with breast or ovarian cancer where each affected individual is a first or second degree relative to another of the affected individuals OR First or second degree male relative with breast cancer diagnosed at any age OR Women of Ashkenazi Jewish descent who meets any of the above criteria with specified ages of onset of 50 for breast cancer and any age for ovarian cancer OR Male with breast cancer diagnosed at any age OR Documented BRCA mutation in the family Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No psychological disorder that may preclude study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019877

Locations
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5000
Sponsors and Collaborators
Investigators
Study Chair: Pamela Klein National Cancer Institute (NCI)
  More Information

No publications provided

Study ID Numbers: CDR0000067273, NCI-99-C-0081, MB-NAVY-B99-015, NCI-NMOB-9811
Study First Received: March 2, 2007
Last Updated: March 2, 2007
ClinicalTrials.gov Identifier: NCT00019877     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult solid tumor
body system/site cancer
breast cancer
cancer
female reproductive cancer
genetic condition
male breast cancer
ovarian epithelial cancer
solid tumor

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Cancer, Male
Ovarian Epithelial Cancer
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms, Male
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009