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Methods in Education for Breast Cancer Genetics

18 Years
Open (Enrolling)
Breast Neoplasm, Ovarian Cancer

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Trial Information

Methods in Education for Breast Cancer Genetics

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.

Inclusion Criteria


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.

Type of Study:


Study Design:


Principal Investigator

Kathleen Calzone, R.N.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

  • Breast Neoplasm
  • Ovarian Cancer
  • Information
  • Decisions
  • Counseling
  • Hereditary
  • BRCA
  • Group
  • Individual
  • Genetic Testing
  • Genetic Counseling
  • Genetic Education
  • Informed Consent
  • Breast Cancer
  • Ovarian Cancer
  • Known Family Mutation
  • Breast Neoplasms
  • Neoplasms
  • Ovarian Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
National Naval Medical Center Bethesda, Maryland  20889