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Methods in Education for Breast Cancer Genetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001806
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : December 3, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Other: Genetic Education and Counseling Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Methods in Education for Breast Cancer Genetics
Study Start Date : April 6, 1999
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Arm Intervention/treatment
Experimental: Group
Group education and counseling
Other: Genetic Education and Counseling
Group Education and Counseling

Active Comparator: Individual
Individual education and counseling
Other: Genetic Education and Counseling
Individual Education and Counlseing

Primary Outcome Measures :
  1. Impact of Events Scale [ Time Frame: Baseline, 3, 6, and 12 months ]
  2. Breast Cancer Genetics Knowledge Score [ Time Frame: Baseline, 3, 6, and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

At least one of the following:

Diagnosis of breast cancer, or DCIS prior to or at 45, or ovarian cancer prior to or at age 50;

Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer and ovarian cancer in the same individual;

Diagnosis of breast or ovarian cancer and one first or second degree relative with breast cancer diagnosed prior to or at age 45, or ovarian cancer prior to or at age 50;

Diagnosis of breast or ovarian cancer and three relatives in the same lineage with breast or ovarian cancer; each affected individual must be a first- or second-degree relative to another of the affected individuals;

Diagnosis of breast or ovarian cancer and a first or second degree male relative with breast cancer;

A woman 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;

A male with breast cancer diagnosed at any age;

Documented BRCA mutation in the family.

All individuals must be able to give informed consent.


Patients will be considered ineligible for any of the following reasons:

Any psychological disorder which may hinder the participant's ability to understand and process the material, based on a psychiatric consultation.

Inable to return for 2 visits.

Age under 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001806

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United States, Maryland
Walter Reed National Medical Center
Bethesda, Maryland, United States, 20301
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Kathleen Calzone, R.N. National Cancer Institute (NCI)

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00001806     History of Changes
Obsolete Identifiers: NCT00019877
Other Study ID Numbers: 990081
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 6, 2017
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genetic Testing
Genetic Counseling
Genetic Education
Informed Consent
Breast Cancer
Ovarian Cancer
Known Family Mutation
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders